"Single-Shot" Vaccines May Protect Against H5N1 Influenza Virus
Two newly developed "single-shot" H5N1 influenza vaccines protected ferrets against lethal infection with the H5N1 influenza virus and may allow for mass vaccination in humans in the event of a pandemic outbreak. The researchers from Australia report their findings in the August 2009 issue of the Journal of Virology.
As the highly infectious H5N1 influenza A virus continues to persist in bird populations and infect humans through poultry, concerns of a pandemic outbreak remain high. Although human-to-human transmission has remained limited, the fatality rate among those reported human cases is greater than 60%. The threat that the virus will mutate and achieve efficient human-to-human spread emphasizes the need for effective preventative therapies.
Vaccination is considered the optimal method for controlling an influenza pandemic. Vaccines must be rapidly available to reach mass populations and they must include the minimal antigen dose (substance that promotes the generation of antibodies) to result in full immunity. The use of adjuvants (substances to improve the immune response) in vaccine development may lower the antigen dose required and ultimately ease the demand on vaccine supply during a pandemic.
Clinical trials on prepandemic vaccines containing adjuvant suggested that two injections were necessary to induce protective immunity. In this study researchers first inoculated ferrets twice with two H5N1 influenza virus adjuvant vaccines (Iscomatrix and AIPO4) and observed for protective efficacy following a lethal challenge with the H5N1 virus. Results showed that ferrets were completely protected against death and disease for at least 15 months. More significantly, a secondary study found that both adjuvant vaccines also protected ferrets from death following only a single inoculation. Specifically, ferrets receiving a single shot of the Iscomatrix adjuvant vaccine displayed fewer signs of infection and remained highly active.
"Our data provide the first indication that in the event of a future influenza pandemic, effective mass vaccination may be achievable with a low-dose 'single shot' vaccine and provide not only increased survival but also significant reduction in disease severity," say the researchers.
(D. Middleton, S. Rockman, M. Pearse, I. Barr, S. Lowther, J. Klippel, D. Ryan, L. Brown. 2009. Evaluation of vaccines for H5N1 influenza virus in ferrets reveals the potential for protective single-shot immunization. Journal of Virology, 83. 15: 7770-7778.)
Infection-Causing Amoeba May be Resistant to Multiple Contact Lens Solutions
A new study suggests that some contact lens solutions do not properly disinfect against Acanthamoeba, a free-living organism in the environment that can cause a painful vision-threatening infection. The researchers from the Centers for Disease Control and Prevention, Public Health Service, and the U.S. Department of Health and Human Services, Atlanta, Georgia, report their findings in the July 2009 issue of the Journal of Clinical Microbiology.
Acanthamoeba are found in a variety of environmental sources including soil, freshwater, brackish water and seawater, as well as hot tubs and Jacuzzis. The species is associated with many different human diseases such as central nervous system infections and Acanthamoeba keratitis (AK), an infection of the cornea that can ultimately lead to blindness. 85% of AK cases in the United States are attributed to contact lens wear, with some specific risk factors being improper contact lens care and contact with nonsterile water during wear.
Insufficient anti-Acanthamoeba activity in Advanced Medical Optics Complete MoisturePlus multipurpose contact lens solution was brought to attention following a recent multistate outbreak of AK. While investigating that outbreak, researchers also compared the effectiveness of 11 other contact lens solutions against cysts of Acanthamoeba castellanii, Acanthamoeba polyphaga, and Acanthamoeba hatchetti, all of which were sample specimens collected during the outbreak. Results indicated that only the two contact lens solutions containing hydrogen peroxide showed any disinfection ability against A. castellanii and A. polyphaga after 6 or 24 hours. No significant disinfection efficacy was noted among the 11 solutions against A. hatchetti.
"The prevention of future cases of AK will require contact lens solutions that are effective against Acanthamoeba species and continued emphasis on proper lens care hygiene," say the researchers. "Educating contact lens wearers about the risk factors for AK, including the improper use of contact lens solutions, is important; but a systematic method for evaluating contact lens solutions will reduce the chance that inefficacious solutions are available."
(S.P. Johnston, R. Sriram, Y. Ovarnstrom, S. Roy, J. Verani, J. Yoder, S. Lorick, J. Roberts, M.J. Beach, G. Visvesvara. 2009. Resistance of Acanthamoeba cysts to disinfection in multiple contact lens solutions. Journal of Clinical Microbiology, 47. 7: 2040-2045.)
New DNA Vaccine Inhibits Deadly Skin Cancer in Mice
A new DNA vaccine inhibited malignant melanoma, a deadly form of skin cancer, in mice by eliciting antibodies that target a gastrin-releasing peptide which is known to play a key role in cancer development. The researchers from China and the U.S. report their findings in the July 2009 issue of the journal Clinical and Vaccine Immunology.
Gastrin-releasing peptide (GRP) is an important human peptide that regulates gastric acid secretion and motor function as well as elicits gastrin release. Previous research has shown that GRP plays a significant role in human cancers through atypical expression of the GRP receptor and GRP binding that activates cellular signaling and results in increased cell production and tumor formation. Anti-GRP antibodies have displayed promising antitumoral activity and DNA vaccines targeting GRP are a hopeful therapeutic approach.
In the study researchers developed a novel anti-GRP DNA vaccine including various immunoadjuvants (substances to improve the immune response) and monitored anti-GRP antibody levels in vaccinated mice. Intramuscular injections induced high levels of specific antibodies against GRP as well as suppressed the growth of melanoma cells. Additionally, researchers intravenously injected cells in the lungs and found that cells were highly diminished indicating that the vaccine may also inhibit cancer from spreading.
"In conclusion, we have demonstrated for the first time that immune responses which are elicited by a novel anti-GRP DNA vaccine suppress the proliferation and growth of melanoma tumors in mice," say the researchers. "The antiangiogenesis and antimetastastic activities of this DNA vaccine suggest a novel approach against various cancers, especially malignant melanoma."
(J. Fang, Y. Lu, K. Ouyang, G. Wu, H. Zhang, Y. Liu, Y. Chen, M. Lin, H. Wang, L. Jin, R. Cao, R.S. Roque, L. Zong, J. Liu, T. Li. 2009. Specific antibodies elicited by a novel DNA vaccine targeting gastrin-releasing peptide inhibit murine melanoma growth in vitro. Clinical and Vaccine Immunology, 16. 7: 1033-1039.)
Source:
Carrie Slijepcevic
American Society for Microbiology
среда, 13 апреля 2011 г.
Epidemiology Of Human H5N1 Cases Reported To WHO
Last week's issue of the Weekly Epidemiological Record, published online by WHO, sets out results from the first analysis of epidemiological data on all 205 laboratory-confirmed H5N1 cases officially reported to WHO by onset date from December 2003 to 30 April 2006.
Data used in the analysis were collected for surveillance purposes. Quality, reliability and format were not consistent across data from different countries.
Despite this limitation, several conclusions could be reached
-- The number of new countries reporting human cases increased from 4 to 9 after October 2005, following the geographical extension of outbreaks among avian populations.
-- Half of the cases occurred in people under the age of 20 years; 90% of cases occurred in people under the age of 40 years.
-- The overall case-fatality rate was 56%. Case fatality was high in all age groups but was highest in persons aged 10 to 39 years.
-- The case-fatality profile by age group differs from that seen in seasonal influenza, where mortality is highest in the elderly.
-- The overall case-fatality rate was highest in 2004 (73%), followed by 63% to date in 2006, and 43% in 2005.
-- Assessment of mortality rates and the time intervals between symptom onset and hospitalization and between symptom onset and death suggests that the illness pattern has not changed substantially during the three years.
-- Cases have occurred all year round. However, the incidence of human cases peaked, in each of the three years in which cases have occurred, during the period roughly corresponding to winter and spring in the northern hemisphere. If this pattern continues, an upsurge in cases could be anticipated starting in late 2006 or early 2007.
A more standardized collection of epidemiological data by countries and timely sharing of these data are needed to improve monitoring of the situation, risk assessment, and the management of H5N1 patients.
For more information
Epidemiology of WHO-confirmed human cases of avian A(H5N1) infection
30 June 2006, Weekly Epidemiological Record (WER) vol. 81, 26 (pp 249-260)
who.int/csr/don/2006_06_30/en/index.html
Data used in the analysis were collected for surveillance purposes. Quality, reliability and format were not consistent across data from different countries.
Despite this limitation, several conclusions could be reached
-- The number of new countries reporting human cases increased from 4 to 9 after October 2005, following the geographical extension of outbreaks among avian populations.
-- Half of the cases occurred in people under the age of 20 years; 90% of cases occurred in people under the age of 40 years.
-- The overall case-fatality rate was 56%. Case fatality was high in all age groups but was highest in persons aged 10 to 39 years.
-- The case-fatality profile by age group differs from that seen in seasonal influenza, where mortality is highest in the elderly.
-- The overall case-fatality rate was highest in 2004 (73%), followed by 63% to date in 2006, and 43% in 2005.
-- Assessment of mortality rates and the time intervals between symptom onset and hospitalization and between symptom onset and death suggests that the illness pattern has not changed substantially during the three years.
-- Cases have occurred all year round. However, the incidence of human cases peaked, in each of the three years in which cases have occurred, during the period roughly corresponding to winter and spring in the northern hemisphere. If this pattern continues, an upsurge in cases could be anticipated starting in late 2006 or early 2007.
A more standardized collection of epidemiological data by countries and timely sharing of these data are needed to improve monitoring of the situation, risk assessment, and the management of H5N1 patients.
For more information
Epidemiology of WHO-confirmed human cases of avian A(H5N1) infection
30 June 2006, Weekly Epidemiological Record (WER) vol. 81, 26 (pp 249-260)
who.int/csr/don/2006_06_30/en/index.html
A Large-Scale Research Project By A Dutch Consortium Addressing A Global Problem
A new and promising research project of Top Institute Pharma is being
conducted by a multi-member Dutch consortium with expertise in the fields
of virology, immunology and vaccine development. The aim of the project is
to develop novel strategies to induce and monitor the humoral and cellular
immunity that protects the host from respiratory virus infections. This
project has a budget of almost 4 million Euros. One of its aims is to
reduce the risk of a pandemic outbreak of influenza, that may emerge from
the current avian influenza threat to humans. The partners in the project
are Solvay Pharmaceuticals B.V., Nobilon International B.V., OctoPlus
N.V., ViroClinics B.V., Virosome Biologicals B.V., the Erasmus University
Medical Center Rotterdam, Leiden University, the University Medical Center
Groningen, Utrecht University and the Netherlands Vaccine Institute.
The project is an initiative of Top Institute Pharma, a public-private
partnership that was founded in 2006. TI Pharma forms consortia of
industrial and academic research teams who conduct ground-breaking,
cross-disciplinary research. Its personnel are trained in improving the
efficiency of the entire drug discovery and development process. Each
year, the Dutch government provides 30 million Euros in funding for the
top institute. The pharmaceutical industry and academia each contribute an
additional 15 million Euros annually. TI Pharma is aiming to become an
international leader in research, training and education.
Professor Ab Osterhaus, principal investigator: "This is a unique project,
because it combines the expertise and knowledge from the fields of
virology, immunology and vaccine development of prominent industrial
partners, knowledge institutes, medical centers and universities.
Therefore, we hope for ground-breaking results."
Respiratory viruses are the cause of a large burden of disease in humans
and although effective vaccines exist to protect against seasonal
influenza, no vaccines are currently available for other important human
respiratory viral diseases such as avian influenza, pandemic influenza and
respiratory syncytial virus (RSV) infection. There are a number of reasons
for this: an incomplete understanding of the correlates of
(vaccine-induced) protection against these infections that stems from
research activities whose focus is too limited, inadequate research tools,
and because efficient vaccine delivery systems for humans are largely
lacking.
Principal investigator Professor Osterhaus: "This project aims to fill
these knowledge gaps in the prevention of respiratory virus infections
through developing a set of tools to enable us to better understand the
roles of both the humoral and the cellular arms of the adaptive immune
system, stimulated by virus infection and vaccination. Other aims of the
project are to develop novel vaccines based on antigens produced by new
manufacturing systems and with innovative delivery systems, that will
induce both humoral and cellular immunity. Pandemic influenza will be used
as the primary model disease as it is considered a major threat and is
part of the World Health Organization's Priority Medicines program.
Certain aspects of the work will be extended to the development of
intervention strategies for RSV infection."
Most seasonal influenza vaccines are inactivated, subunit, whole- or
split-virus vaccines. Vaccines for the highly pathogenic avian influenza
(HPAI) strain H5N1, which may well be the basis of the next pandemic in
humans, have been modelled on such seasonal vaccines but have been proven
to be poorly immunogenic in humans as large doses are required to obtain a
modest and highly restricted immune response. This is likely because
seasonal vaccination acts to boost existing immunity, while the immune
systems of the general population are naГЇve to the H5N1 virus. Professor
Osterhaus: "Given these results, and the insufficient manufacturing
capacity for influenza vaccines in general, it is imperative to develop a
novel generation of vaccines that will enable an increase in manufacturing
capacity, enhanced immunoprotection and vaccination requiring less
injections, allowing maximum protection worldwide."
About OctoPlus
OctoPlus N.V. (Euronext: OCTO) is a biopharmaceutical company creating
improved pharmaceutical products that are based on OctoPlus' drug delivery
technologies and have fewer side effects, improved patient convenience and
a better tolerability than existing products. The Company currently has 4
products in preclinical and clinical development. In addition, OctoPlus is
a leading provider of drug formulation and clinical scale manufacturing
services, with a focus on difficult to formulate active pharmaceutical
ingredients in injectable formulations.
octoplus.nl
About Nobilon
Nobilon International BV, part of Organon, a biopharmaceutical business
unit of Akzo Nobel, was founded in 2003. It has production and R&D
facilities in Boxmeer and Oss, the Netherlands. The biotechnology company
is dedicated to develop, produce and market human vaccines against
infectious diseases, building on existing expertise within sister
companies Intervet and Organon. Nobilon focuses on respiratory and
traveller's diseases. One of its core expertises is large scale cell
culture production of viruses, including influenza. Nobilon currently
employs approximately 75 staff in production and R&D.
nobilon
About Solvay Pharmaceuticals
Solvay Pharmaceuticals is a research driven group of companies that
constitute the global pharmaceutical business of the Solvay Group. The
company seeks to fulfill carefully selected, unmet medical needs in the
therapeutic areas of neuroscience, cardiometabolic, influenza vaccines,
gastroenterology, and men's and women's health. Its 2006 sales were EUR
2.6 billion and it employs approximately 10,000 people worldwide. For more
information, visit solvaypharmaceuticals. Solvay Pharmaceuticals
B.V. is active in the Netherlands and employs about 13 00 people.
About LACDR
LACDR is a center of excellence in innovative drug research and education.
Its research focus is the development of novel concepts, and developing
the knowledge and expertise that make drug discovery, evaluation and
clinical application possible. This includes a fundamental understanding
of drug actions as the basis for evaluating efficacy and safety.
lacdr.nl
About Virosome Biologicals B.V.
Virosome Biologicals B.V. is a wholly owned subsidiary of Norwood
Immunology Limited (NIM), having been acquired in November 2006. NIM is a
group focused on technologies and therapies to activate and manipulate the
immune system, through two platforms: use of temporary sex steroid
suppression to effect rejuvenation of the thymus and bone marrow, with
resulting enhancement of T cell function and immune responsiveness; and
the development of adjuvanted virosomes for vaccines based and as a
delivery mechanism for SiRNA. NIM is quoted on the London AIM Exchange
(AIM: NIM).
About the Netherlands Vaccine Institute
The Netherlands Vaccine Institute, as one of the few institutes in the
world, buys, produces and develops vaccines under the authority of the
government. The NVI protects the Dutch population against infectious
diseases by supplying vaccines under normal as well as extraordinary
circumstances. To achieve this, NVI has expert knowledge about all aspects
of the vaccine value chain, ranging from top class research & development
and clinical trials to high standard pharmaceutical production and
distribution.
nvi-vaccin.nl
conducted by a multi-member Dutch consortium with expertise in the fields
of virology, immunology and vaccine development. The aim of the project is
to develop novel strategies to induce and monitor the humoral and cellular
immunity that protects the host from respiratory virus infections. This
project has a budget of almost 4 million Euros. One of its aims is to
reduce the risk of a pandemic outbreak of influenza, that may emerge from
the current avian influenza threat to humans. The partners in the project
are Solvay Pharmaceuticals B.V., Nobilon International B.V., OctoPlus
N.V., ViroClinics B.V., Virosome Biologicals B.V., the Erasmus University
Medical Center Rotterdam, Leiden University, the University Medical Center
Groningen, Utrecht University and the Netherlands Vaccine Institute.
The project is an initiative of Top Institute Pharma, a public-private
partnership that was founded in 2006. TI Pharma forms consortia of
industrial and academic research teams who conduct ground-breaking,
cross-disciplinary research. Its personnel are trained in improving the
efficiency of the entire drug discovery and development process. Each
year, the Dutch government provides 30 million Euros in funding for the
top institute. The pharmaceutical industry and academia each contribute an
additional 15 million Euros annually. TI Pharma is aiming to become an
international leader in research, training and education.
Professor Ab Osterhaus, principal investigator: "This is a unique project,
because it combines the expertise and knowledge from the fields of
virology, immunology and vaccine development of prominent industrial
partners, knowledge institutes, medical centers and universities.
Therefore, we hope for ground-breaking results."
Respiratory viruses are the cause of a large burden of disease in humans
and although effective vaccines exist to protect against seasonal
influenza, no vaccines are currently available for other important human
respiratory viral diseases such as avian influenza, pandemic influenza and
respiratory syncytial virus (RSV) infection. There are a number of reasons
for this: an incomplete understanding of the correlates of
(vaccine-induced) protection against these infections that stems from
research activities whose focus is too limited, inadequate research tools,
and because efficient vaccine delivery systems for humans are largely
lacking.
Principal investigator Professor Osterhaus: "This project aims to fill
these knowledge gaps in the prevention of respiratory virus infections
through developing a set of tools to enable us to better understand the
roles of both the humoral and the cellular arms of the adaptive immune
system, stimulated by virus infection and vaccination. Other aims of the
project are to develop novel vaccines based on antigens produced by new
manufacturing systems and with innovative delivery systems, that will
induce both humoral and cellular immunity. Pandemic influenza will be used
as the primary model disease as it is considered a major threat and is
part of the World Health Organization's Priority Medicines program.
Certain aspects of the work will be extended to the development of
intervention strategies for RSV infection."
Most seasonal influenza vaccines are inactivated, subunit, whole- or
split-virus vaccines. Vaccines for the highly pathogenic avian influenza
(HPAI) strain H5N1, which may well be the basis of the next pandemic in
humans, have been modelled on such seasonal vaccines but have been proven
to be poorly immunogenic in humans as large doses are required to obtain a
modest and highly restricted immune response. This is likely because
seasonal vaccination acts to boost existing immunity, while the immune
systems of the general population are naГЇve to the H5N1 virus. Professor
Osterhaus: "Given these results, and the insufficient manufacturing
capacity for influenza vaccines in general, it is imperative to develop a
novel generation of vaccines that will enable an increase in manufacturing
capacity, enhanced immunoprotection and vaccination requiring less
injections, allowing maximum protection worldwide."
About OctoPlus
OctoPlus N.V. (Euronext: OCTO) is a biopharmaceutical company creating
improved pharmaceutical products that are based on OctoPlus' drug delivery
technologies and have fewer side effects, improved patient convenience and
a better tolerability than existing products. The Company currently has 4
products in preclinical and clinical development. In addition, OctoPlus is
a leading provider of drug formulation and clinical scale manufacturing
services, with a focus on difficult to formulate active pharmaceutical
ingredients in injectable formulations.
octoplus.nl
About Nobilon
Nobilon International BV, part of Organon, a biopharmaceutical business
unit of Akzo Nobel, was founded in 2003. It has production and R&D
facilities in Boxmeer and Oss, the Netherlands. The biotechnology company
is dedicated to develop, produce and market human vaccines against
infectious diseases, building on existing expertise within sister
companies Intervet and Organon. Nobilon focuses on respiratory and
traveller's diseases. One of its core expertises is large scale cell
culture production of viruses, including influenza. Nobilon currently
employs approximately 75 staff in production and R&D.
nobilon
About Solvay Pharmaceuticals
Solvay Pharmaceuticals is a research driven group of companies that
constitute the global pharmaceutical business of the Solvay Group. The
company seeks to fulfill carefully selected, unmet medical needs in the
therapeutic areas of neuroscience, cardiometabolic, influenza vaccines,
gastroenterology, and men's and women's health. Its 2006 sales were EUR
2.6 billion and it employs approximately 10,000 people worldwide. For more
information, visit solvaypharmaceuticals. Solvay Pharmaceuticals
B.V. is active in the Netherlands and employs about 13 00 people.
About LACDR
LACDR is a center of excellence in innovative drug research and education.
Its research focus is the development of novel concepts, and developing
the knowledge and expertise that make drug discovery, evaluation and
clinical application possible. This includes a fundamental understanding
of drug actions as the basis for evaluating efficacy and safety.
lacdr.nl
About Virosome Biologicals B.V.
Virosome Biologicals B.V. is a wholly owned subsidiary of Norwood
Immunology Limited (NIM), having been acquired in November 2006. NIM is a
group focused on technologies and therapies to activate and manipulate the
immune system, through two platforms: use of temporary sex steroid
suppression to effect rejuvenation of the thymus and bone marrow, with
resulting enhancement of T cell function and immune responsiveness; and
the development of adjuvanted virosomes for vaccines based and as a
delivery mechanism for SiRNA. NIM is quoted on the London AIM Exchange
(AIM: NIM).
About the Netherlands Vaccine Institute
The Netherlands Vaccine Institute, as one of the few institutes in the
world, buys, produces and develops vaccines under the authority of the
government. The NVI protects the Dutch population against infectious
diseases by supplying vaccines under normal as well as extraordinary
circumstances. To achieve this, NVI has expert knowledge about all aspects
of the vaccine value chain, ranging from top class research & development
and clinical trials to high standard pharmaceutical production and
distribution.
nvi-vaccin.nl
Bird Flu Outbreak In Xinjiang, China
China's Agriculture Ministry reports that a new bird flu outbreak among poultry has been reported from Hetian county, in the Xinjiang region, north-west of the country. There are no details of how many birds are infected or have died.
This is the first report of H5N1 infection among farmed poultry since February, 2006. All other reports since then have been concerning wild birds.
The National Bird Flu Laboratory, on Wednseday, confirmed H5N1 as the cause of death of the sick birds.
There have been about 40 outbreaks of H5N1 among birds in China over the past 12 months. 12 humans have died in the country as a result of H5N1 infection.
Since the end of last year Chinese authorities have put into place a massive vaccination campaign, which seems to have had some effect in slowing down the spread of H5N1 among farmed birds.
The Ministry of Agriculture has sent a team of experts to Hetian county - their aim is to try to control the outbreak and stop it from spreading. Vehicles and people moving in and out of the area are being disinfected.
A leading Chinese expert, Liu Xiufan, said China must improve its efforts to control bird flu. He urges China's government to review the effectiveness of current measures. He said 'We should do our best to reduce the risk of a human pandemic influenza breaking out and make necessary preparations before such a risk becomes a reality.'
Written by:
This is the first report of H5N1 infection among farmed poultry since February, 2006. All other reports since then have been concerning wild birds.
The National Bird Flu Laboratory, on Wednseday, confirmed H5N1 as the cause of death of the sick birds.
There have been about 40 outbreaks of H5N1 among birds in China over the past 12 months. 12 humans have died in the country as a result of H5N1 infection.
Since the end of last year Chinese authorities have put into place a massive vaccination campaign, which seems to have had some effect in slowing down the spread of H5N1 among farmed birds.
The Ministry of Agriculture has sent a team of experts to Hetian county - their aim is to try to control the outbreak and stop it from spreading. Vehicles and people moving in and out of the area are being disinfected.
A leading Chinese expert, Liu Xiufan, said China must improve its efforts to control bird flu. He urges China's government to review the effectiveness of current measures. He said 'We should do our best to reduce the risk of a human pandemic influenza breaking out and make necessary preparations before such a risk becomes a reality.'
Written by:
Baxter Announces Preliminary Phase I/II Data For Seasonal Influenza Vaccine Candidate
Baxter International
Inc. (NYSE: BAX) recently announced promising initial study data for its
candidate, Vero cell-based seasonal influenza vaccine, now undergoing a
Phase I/II clinical trial in Europe. The preliminary data indicate that the
vaccine induced strong antibody responses and good tolerability in all
study populations.
The findings were presented by Hartmut J. Ehrlich, M.D., vice president
of Global Research and Development for Baxter's BioScience business at a
June gathering of laboratory and clinical scientists and public health
professionals at the Options for the Control of Influenza VI Conference in
Toronto, Canada. The active, controlled, multi-center Phase I/II trial of
the seasonal influenza vaccine was designed to evaluate safety and
immunogenicity of the candidate vaccine in approximately 940 subjects
divided between the ages of 18-49 and 50 years of age and older.
The Phase I/II study data indicate that Baxter's seasonal candidate
vaccine, which was developed using a split virus process, was effective in
inducing protective levels of antibodies for all three seasonal virus
strains in both age levels. Split viruses are most frequently used for
seasonal influenza vaccines. Baxter's investigational pandemic H5N1
influenza vaccine, currently in Phase III trials in Europe, was developed
using a whole-virus process.
In the 18-49 subject population, 99.6 percent achieved protective
antibody levels for virus strains H1N1 and H3N2, and 92.9 percent for
strain B. In the 50 years of age and older population, 96.6 percent
achieved protective levels for virus strain H1N1, 100 percent for H3N2 and
73.3 percent for strain B.
Work on this vaccine is being completed as part of a U.S. Department of
Health and Human Services (DHHS) Office of Public Health and Emergency
Preparedness contract awarded to DynPort Vaccine Company LLC (DVC), a
Computer Sciences Corporation (NYSE: CSC) company, and Baxter in May 2006
to develop seasonal and pandemic influenza vaccines. Under this contract,
DVC is managing the project and clinical trials. Baxter is manufacturing
the vaccines and will serve as the U.S. Food and Drug Administration (FDA)
license-holder.
"I am very encouraged by the preliminary results of this Phase I/II
clinical trial, which suggest that this cell culture-derived vaccine may
provide protection against seasonal influenza with minimal side effects,"
said Frank von Sonnenburg, M.D., head of the Section of International
Medicine and Public Health in the Department of Infectious Diseases and
Tropical Medicine at the University of Munich.
Baxter's seasonal influenza candidate vaccine is manufactured using the
company's proprietary Vero cell technology. The use of Vero cell culture,
rather than conventional egg-based technology, offers several advantages.
Baxter's Vero cell culture process can be initiated more rapidly due to its
use of a "native" virus that does not need to be modified to allow growth
in eggs, thus accelerating vaccine availability. Vaccines produced using
the process can be released within approximately 12 weeks, significantly
earlier than with traditional egg-based systems. In addition, all influenza
strains with pandemic potential tested for growth in Vero cells have
produced consistent high yields, providing the flexibility to quickly
respond to emerging variant pandemic virus strains.
"Combined with the recent encouraging results from our pandemic H5N1
clinical trial, these data provide further evidence suggesting the Vero
cell platform can reliably deliver safe and effective influenza vaccines in
pandemic or interpandemic situations," said Dr. Noel Barrett, vice
president of Global Research and Development for Baxter's Vaccines
Business. "This early indication of an acceptable safety profile and
immunity against key seasonal influenza viral strains is critically
important as we plan the Phase III clinical trial program to provide a
solid measure of the vaccine's potential to protect a large number of
people during the influenza season."
Phase I/II Data
Preliminary data from the Phase I/II clinical trial presented at the
Toronto meeting showed the candidate vaccine's tolerability profile to be
similar to currently marketed, egg-based seasonal flu vaccines. The vaccine
also generated substantial levels of cross immunity against three seasonal
strains. The most common side effects observed for the trial vaccine were
injection site reactions, headaches and malaise.
In addition, the analysis demonstrated that the vaccine met European
Committee for Medicinal Products for Human Use (CHMP) criterion for
influenza vaccine licensure with all three strains, in both age groups
tested. The criterion requires that adults achieve specific levels of
immunity or "seroprotection" following vaccination.
ACKNOWLEDGEMENTS:
1. This project has been funded in whole or in part with Federal (United
States Government) funds from the Office of Public Health Emergency
Preparedness, Office of Research and Development Coordination, under
contract number HHS0100200600013C.
2. Pursuant to Section 507 of P.L. 104-208 and Section 508 of P.L. 105-78;
100% of the total of this project's costs are financed with Federal
(United States Government) money.
3. The content of this publication does not necessarily reflect the views
or policies of the United States Department of Health and Human
Services, nor does mention of trade names, commercial products, or
organizations imply endorsement by the U.S. Government.
About CSC
Computer Sciences Corporation is a leading global information
technology (IT) services company. CSC's mission is to provide customers in
industry and government with solutions crafted to meet their specific
challenges and enable them to profit from the advanced use of technology.
With approximately 87,000 employees, CSC provides innovative solutions
for customers around the world by applying leading technologies and CSC's
own advanced capabilities. These include systems design and integration; IT
and business process outsourcing; applications software development; Web
and application hosting; and management consulting. Headquartered in El
Segundo, Calif., CSC reported revenue of $14.9 billion for the 12 months
ended March 30, 2007. For more information, visit the company's Web site at
csc.
About Baxter
Baxter International Inc., through its subsidiaries, assists healthcare
professionals and their patients with the treatment of complex medical
conditions, including hemophilia, immune disorders, cancer, infectious
diseases, kidney disease, trauma and other conditions. The company applies
its expertise in medical devices, pharmaceuticals and biotechnology to make
a meaningful difference in patients' lives.
The safety and efficacy of this product has not been established. This
product is currently under clinical investigation and has not been licensed
by the FDA.
This release includes forward-looking statements concerning the
company's vaccine products, including with respect to clinical trials,
licensures, and the advantages of the vaccine products. The statements are
based on assumptions about many important factors, including the following,
which could cause actual results to differ materially from those in the
forward-looking statements: satisfaction of regulatory and other
requirements for timely commencement of additional clinical trials;
additional clinical results demonstrating the safety and efficacy of the
products; market acceptance of vaccines developed with Vero cell technology
relative to egg- based or other alternatives; continued public commitment
to addressing avian flu and other pandemic threats including additional
experience producing such vaccines at a large scale; and other risks
identified in the company's most recent filing on Form 10-Q and other SEC
filings, all of which are available on the company's web site. The company
does not undertake to update its forward-looking statements.
Baxter International
baxter
Inc. (NYSE: BAX) recently announced promising initial study data for its
candidate, Vero cell-based seasonal influenza vaccine, now undergoing a
Phase I/II clinical trial in Europe. The preliminary data indicate that the
vaccine induced strong antibody responses and good tolerability in all
study populations.
The findings were presented by Hartmut J. Ehrlich, M.D., vice president
of Global Research and Development for Baxter's BioScience business at a
June gathering of laboratory and clinical scientists and public health
professionals at the Options for the Control of Influenza VI Conference in
Toronto, Canada. The active, controlled, multi-center Phase I/II trial of
the seasonal influenza vaccine was designed to evaluate safety and
immunogenicity of the candidate vaccine in approximately 940 subjects
divided between the ages of 18-49 and 50 years of age and older.
The Phase I/II study data indicate that Baxter's seasonal candidate
vaccine, which was developed using a split virus process, was effective in
inducing protective levels of antibodies for all three seasonal virus
strains in both age levels. Split viruses are most frequently used for
seasonal influenza vaccines. Baxter's investigational pandemic H5N1
influenza vaccine, currently in Phase III trials in Europe, was developed
using a whole-virus process.
In the 18-49 subject population, 99.6 percent achieved protective
antibody levels for virus strains H1N1 and H3N2, and 92.9 percent for
strain B. In the 50 years of age and older population, 96.6 percent
achieved protective levels for virus strain H1N1, 100 percent for H3N2 and
73.3 percent for strain B.
Work on this vaccine is being completed as part of a U.S. Department of
Health and Human Services (DHHS) Office of Public Health and Emergency
Preparedness contract awarded to DynPort Vaccine Company LLC (DVC), a
Computer Sciences Corporation (NYSE: CSC) company, and Baxter in May 2006
to develop seasonal and pandemic influenza vaccines. Under this contract,
DVC is managing the project and clinical trials. Baxter is manufacturing
the vaccines and will serve as the U.S. Food and Drug Administration (FDA)
license-holder.
"I am very encouraged by the preliminary results of this Phase I/II
clinical trial, which suggest that this cell culture-derived vaccine may
provide protection against seasonal influenza with minimal side effects,"
said Frank von Sonnenburg, M.D., head of the Section of International
Medicine and Public Health in the Department of Infectious Diseases and
Tropical Medicine at the University of Munich.
Baxter's seasonal influenza candidate vaccine is manufactured using the
company's proprietary Vero cell technology. The use of Vero cell culture,
rather than conventional egg-based technology, offers several advantages.
Baxter's Vero cell culture process can be initiated more rapidly due to its
use of a "native" virus that does not need to be modified to allow growth
in eggs, thus accelerating vaccine availability. Vaccines produced using
the process can be released within approximately 12 weeks, significantly
earlier than with traditional egg-based systems. In addition, all influenza
strains with pandemic potential tested for growth in Vero cells have
produced consistent high yields, providing the flexibility to quickly
respond to emerging variant pandemic virus strains.
"Combined with the recent encouraging results from our pandemic H5N1
clinical trial, these data provide further evidence suggesting the Vero
cell platform can reliably deliver safe and effective influenza vaccines in
pandemic or interpandemic situations," said Dr. Noel Barrett, vice
president of Global Research and Development for Baxter's Vaccines
Business. "This early indication of an acceptable safety profile and
immunity against key seasonal influenza viral strains is critically
important as we plan the Phase III clinical trial program to provide a
solid measure of the vaccine's potential to protect a large number of
people during the influenza season."
Phase I/II Data
Preliminary data from the Phase I/II clinical trial presented at the
Toronto meeting showed the candidate vaccine's tolerability profile to be
similar to currently marketed, egg-based seasonal flu vaccines. The vaccine
also generated substantial levels of cross immunity against three seasonal
strains. The most common side effects observed for the trial vaccine were
injection site reactions, headaches and malaise.
In addition, the analysis demonstrated that the vaccine met European
Committee for Medicinal Products for Human Use (CHMP) criterion for
influenza vaccine licensure with all three strains, in both age groups
tested. The criterion requires that adults achieve specific levels of
immunity or "seroprotection" following vaccination.
ACKNOWLEDGEMENTS:
1. This project has been funded in whole or in part with Federal (United
States Government) funds from the Office of Public Health Emergency
Preparedness, Office of Research and Development Coordination, under
contract number HHS0100200600013C.
2. Pursuant to Section 507 of P.L. 104-208 and Section 508 of P.L. 105-78;
100% of the total of this project's costs are financed with Federal
(United States Government) money.
3. The content of this publication does not necessarily reflect the views
or policies of the United States Department of Health and Human
Services, nor does mention of trade names, commercial products, or
organizations imply endorsement by the U.S. Government.
About CSC
Computer Sciences Corporation is a leading global information
technology (IT) services company. CSC's mission is to provide customers in
industry and government with solutions crafted to meet their specific
challenges and enable them to profit from the advanced use of technology.
With approximately 87,000 employees, CSC provides innovative solutions
for customers around the world by applying leading technologies and CSC's
own advanced capabilities. These include systems design and integration; IT
and business process outsourcing; applications software development; Web
and application hosting; and management consulting. Headquartered in El
Segundo, Calif., CSC reported revenue of $14.9 billion for the 12 months
ended March 30, 2007. For more information, visit the company's Web site at
csc.
About Baxter
Baxter International Inc., through its subsidiaries, assists healthcare
professionals and their patients with the treatment of complex medical
conditions, including hemophilia, immune disorders, cancer, infectious
diseases, kidney disease, trauma and other conditions. The company applies
its expertise in medical devices, pharmaceuticals and biotechnology to make
a meaningful difference in patients' lives.
The safety and efficacy of this product has not been established. This
product is currently under clinical investigation and has not been licensed
by the FDA.
This release includes forward-looking statements concerning the
company's vaccine products, including with respect to clinical trials,
licensures, and the advantages of the vaccine products. The statements are
based on assumptions about many important factors, including the following,
which could cause actual results to differ materially from those in the
forward-looking statements: satisfaction of regulatory and other
requirements for timely commencement of additional clinical trials;
additional clinical results demonstrating the safety and efficacy of the
products; market acceptance of vaccines developed with Vero cell technology
relative to egg- based or other alternatives; continued public commitment
to addressing avian flu and other pandemic threats including additional
experience producing such vaccines at a large scale; and other risks
identified in the company's most recent filing on Form 10-Q and other SEC
filings, all of which are available on the company's web site. The company
does not undertake to update its forward-looking statements.
Baxter International
baxter
Global meeting to develop common approach on avian influenza and human pandemic influenza
The H5N1 avian influenza virus is firmly established among animals in Asia and has begun to extend its reach into Europe. From 7-9 November, more than 400 animal and human health experts, senior policy makers, economists and industry representatives will gather in Geneva to work towards a global consensus to control the virus in domestic animals and prepare for a potential human influenza pandemic.
The disease in animals caused by the H5N1 influenza virus has resulted in the culling of at least 150 million birds in the last two years. H5N1 remains for the moment an animal disease, but the World Health Organization (WHO) has warned that H5N1 is a virus that has the potential to ignite a human influenza pandemic.
While no one can predict the timing or severity of the next influenza pandemic, governments around the world are taking the threat seriously. A series of international meetings held over the last ten weeks will culminate in the Geneva meeting. The meeting is co-organized by WHO, the Food and Agriculture Organisation (FAO), the World Organisation for Animal Health (OIE) and the World Bank. The goal of the meeting is to work towards a global consensus for controlling the disease in animals while simultaneously preparing for a potential human pandemic.
"This virus is very treacherous," says Dr Margaret Chan, Representative of the WHO Director-General for Pandemic Influenza. "While we cannot predict when or if the H5N1 virus might spark a pandemic, we cannot ignore the warning signs." Because influenza pandemics have typically caused enormous social and economic disruption, WHO is advising its member states to develop national strategies to cope with such a public health emergency, as well as coordinating with international partners to develop a comprehensive response.
The Geneva meeting will first consider how to contain the H5N1 virus in birds. "There is still a window of opportunity for substantially reducing the risk of a human pandemic evolving from H5N1 by controlling the virus at its source, in animals," says Joseph Domenech, FAO Chief Veterinary Officer. As the FAO expects avian influenza to reach the Middle East and Africa in the near future, it is essential that the global community and affected countries mobilize more resources to combat the virus, which is thought to be spread in part by migratory birds, before it becomes embedded in new regions.
Strengthening disease surveillance systems worldwide will also be high on the agenda at the Geneva meeting. Early detection and rapid response mechanisms are essential to tracking the evolution of the H5N1 virus. Therefore, delegates will also discuss ways to strengthen veterinary and human health services so that any H5N1 cases--in animals or humans--will be identified quickly. "This is crucial for the prevention of any future global crisis associated with emerging animal diseases potentially transmissible to humans," says Dr Bernard Vallat, Director-General of the World Organisation for Animal Health (OIE).
At the same time that animal control efforts are to be intensified, several critical issues related to potential human disease remain to be addressed. Meetings in the last several months have identified several key pandemic preparedness issues. For example, many countries are concerned about the lack of access to antiviral medicines and the antiquated production methods for human influenza vaccines. Communication with the public is also a critical issue. These and other topics will be on the agenda for the Geneva meeting.
The meeting comes after a recent gathering of experts in Geneva (2-3 November) to discuss the development of pandemic influenza vaccines. At present, at least ten vaccine developers in about as many countries are carrying out demonstration projects to develop and evaluate vaccines primarily against the H5N1 subtype. Participants expressed the need for continued sharing of technical information, strengthened international coordination of work related to pandemic influenza vaccines so as to avoid duplication of efforts, support to vaccine research initiatives in developing countries and integrating the science into the public health context.
"It's impossible to exaggerate how important pandemic preparedness is, and how dire the consequences would be for the entire world if some of the worst-case scenarios for a human influenza pandemic were to unfold," says James Adams, the World Bank's Vice-President for Operations Policy and Country Services, and head of the Bank's avian flu taskforce. The Geneva meeting will provide an opportunity for all international partners to mobilize the country commitment and financial resources needed to manage this global threat.
"For the first time in human history, we have a chance to prepare ourselves for a pandemic before it arrives," says Dr Chan. "It is incumbent upon the global community to act now."
Mr Dick Thompson - Communications officer
Communicable Diseases
WHO/Geneva
E-mail: thompsondwho.int
Mr Iain Simpson - Communications Officer
Director-General's Office - WHO
E-mail: simpsoniwho.int
who.int/mediacentre/news/releases/2005/pr56/en/index.html
The disease in animals caused by the H5N1 influenza virus has resulted in the culling of at least 150 million birds in the last two years. H5N1 remains for the moment an animal disease, but the World Health Organization (WHO) has warned that H5N1 is a virus that has the potential to ignite a human influenza pandemic.
While no one can predict the timing or severity of the next influenza pandemic, governments around the world are taking the threat seriously. A series of international meetings held over the last ten weeks will culminate in the Geneva meeting. The meeting is co-organized by WHO, the Food and Agriculture Organisation (FAO), the World Organisation for Animal Health (OIE) and the World Bank. The goal of the meeting is to work towards a global consensus for controlling the disease in animals while simultaneously preparing for a potential human pandemic.
"This virus is very treacherous," says Dr Margaret Chan, Representative of the WHO Director-General for Pandemic Influenza. "While we cannot predict when or if the H5N1 virus might spark a pandemic, we cannot ignore the warning signs." Because influenza pandemics have typically caused enormous social and economic disruption, WHO is advising its member states to develop national strategies to cope with such a public health emergency, as well as coordinating with international partners to develop a comprehensive response.
The Geneva meeting will first consider how to contain the H5N1 virus in birds. "There is still a window of opportunity for substantially reducing the risk of a human pandemic evolving from H5N1 by controlling the virus at its source, in animals," says Joseph Domenech, FAO Chief Veterinary Officer. As the FAO expects avian influenza to reach the Middle East and Africa in the near future, it is essential that the global community and affected countries mobilize more resources to combat the virus, which is thought to be spread in part by migratory birds, before it becomes embedded in new regions.
Strengthening disease surveillance systems worldwide will also be high on the agenda at the Geneva meeting. Early detection and rapid response mechanisms are essential to tracking the evolution of the H5N1 virus. Therefore, delegates will also discuss ways to strengthen veterinary and human health services so that any H5N1 cases--in animals or humans--will be identified quickly. "This is crucial for the prevention of any future global crisis associated with emerging animal diseases potentially transmissible to humans," says Dr Bernard Vallat, Director-General of the World Organisation for Animal Health (OIE).
At the same time that animal control efforts are to be intensified, several critical issues related to potential human disease remain to be addressed. Meetings in the last several months have identified several key pandemic preparedness issues. For example, many countries are concerned about the lack of access to antiviral medicines and the antiquated production methods for human influenza vaccines. Communication with the public is also a critical issue. These and other topics will be on the agenda for the Geneva meeting.
The meeting comes after a recent gathering of experts in Geneva (2-3 November) to discuss the development of pandemic influenza vaccines. At present, at least ten vaccine developers in about as many countries are carrying out demonstration projects to develop and evaluate vaccines primarily against the H5N1 subtype. Participants expressed the need for continued sharing of technical information, strengthened international coordination of work related to pandemic influenza vaccines so as to avoid duplication of efforts, support to vaccine research initiatives in developing countries and integrating the science into the public health context.
"It's impossible to exaggerate how important pandemic preparedness is, and how dire the consequences would be for the entire world if some of the worst-case scenarios for a human influenza pandemic were to unfold," says James Adams, the World Bank's Vice-President for Operations Policy and Country Services, and head of the Bank's avian flu taskforce. The Geneva meeting will provide an opportunity for all international partners to mobilize the country commitment and financial resources needed to manage this global threat.
"For the first time in human history, we have a chance to prepare ourselves for a pandemic before it arrives," says Dr Chan. "It is incumbent upon the global community to act now."
Mr Dick Thompson - Communications officer
Communicable Diseases
WHO/Geneva
E-mail: thompsondwho.int
Mr Iain Simpson - Communications Officer
Director-General's Office - WHO
E-mail: simpsoniwho.int
who.int/mediacentre/news/releases/2005/pr56/en/index.html
Medicago Receives Regulatory Approval To Begin Human Clinical Testing With Its Avian Flu Pandemic Vaccine
Medicago Inc. (TSX VENTURE:MDG) a biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), announced that it has received clearance from Health Canada to commence a Phase I human clinical trial with its H5N1 Avian Influenza vaccine ("H5N1 vaccine"). Enrollment of volunteers is now underway.
The Phase I placebo-controlled, double-blind, dose-escalating study will evaluate safety, tolerability and the immune response of the Company's H5N1 vaccine candidate in up to 48 healthy volunteers between the ages 18 to 60. Volunteers will receive two doses, injected 21 days apart of either a placebo or the influenza vaccine at doses of 5, 10 or 20 micrograms. The trial will take place at the Vaccine Evaluation Center of McGill University in Montreal, Canada, under the supervision of Dr. Brian Ward. Results of this study are expected during the fourth quarter of 2009.
"The acceptance of our Clinical Trial Application by Health Canada represents a major milestone in the company's development of novel influenza vaccines. It is a testament to the quality of our technology and demonstrates our ability to advance candidates towards human trials," said Andy Sheldon, President and CEO of Medicago. "This trial will be the first in which a plant-based vaccine will be injected into humans in Canada. We believe we have a compelling vaccine against influenza - a candidate, which at low dosage may protect against different strains of influenza that have the potential of becoming a pandemic. Combined with our rapid response and low cost manufacturing capabilities, we believe our vaccine would address an unmet gap in pandemic influenza preparedness efforts."
"All of our studies to date confirm that we have a safe and effective vaccine candidate entering human trials," said Nathalie Landry, VP Product Development of Medicago." The data collected will support further clinical trials expected in 2010. As our influenza vaccines candidates are produced using the same manufacturing platform, favourable safety information from this trial may support our other programs and reduce overall development timelines. Furthermore, by conducting this first trial in Canada we will also have the opportunity to build a robust application that will satisfy regulatory requirements of U.S. and European regulatory agencies at a later stage of clinical development."
About Medicago's pandemic flu vaccine candidate
Medicago's H5N1 vaccine candidate was formulated to protect against the Indonesian influenza virus. It is manufactured in Nicotiana benthamiana, a relative of the tobacco plant, using the Company's proprietary VLP technology. VLPs have several advantages over traditional flu vaccines. They are made to look like a virus, allowing them to be recognized readily by the body's immune system, however, they lack the core genetic material making them non-infectious and unable to replicate. Medicago's VLP-based vaccine has shown in preclinical studies it can provide protection against different strains of avian flu, such as the Vietnam and Turkey strains, and it may provide significant immune protection after a single dose. FDA-approved H5N1 influenza vaccines in the United States require two 90-microgram doses, administered at least four weeks apart to achieve appropriate level of antibodies in 44% of vaccinated individuals. Because Medicago's technology requires the genetic sequence of a viral strain and not the live influenza virus, vaccines can be manufactured within 4 weeks of obtaining the genetic sequence of a pandemic strain. This is in contrast with all current manufacturing technologies which rely on strain adaptation, a process that requires an additional 4-6 months before vaccine production can be initiated.
Source
Medicago
The Phase I placebo-controlled, double-blind, dose-escalating study will evaluate safety, tolerability and the immune response of the Company's H5N1 vaccine candidate in up to 48 healthy volunteers between the ages 18 to 60. Volunteers will receive two doses, injected 21 days apart of either a placebo or the influenza vaccine at doses of 5, 10 or 20 micrograms. The trial will take place at the Vaccine Evaluation Center of McGill University in Montreal, Canada, under the supervision of Dr. Brian Ward. Results of this study are expected during the fourth quarter of 2009.
"The acceptance of our Clinical Trial Application by Health Canada represents a major milestone in the company's development of novel influenza vaccines. It is a testament to the quality of our technology and demonstrates our ability to advance candidates towards human trials," said Andy Sheldon, President and CEO of Medicago. "This trial will be the first in which a plant-based vaccine will be injected into humans in Canada. We believe we have a compelling vaccine against influenza - a candidate, which at low dosage may protect against different strains of influenza that have the potential of becoming a pandemic. Combined with our rapid response and low cost manufacturing capabilities, we believe our vaccine would address an unmet gap in pandemic influenza preparedness efforts."
"All of our studies to date confirm that we have a safe and effective vaccine candidate entering human trials," said Nathalie Landry, VP Product Development of Medicago." The data collected will support further clinical trials expected in 2010. As our influenza vaccines candidates are produced using the same manufacturing platform, favourable safety information from this trial may support our other programs and reduce overall development timelines. Furthermore, by conducting this first trial in Canada we will also have the opportunity to build a robust application that will satisfy regulatory requirements of U.S. and European regulatory agencies at a later stage of clinical development."
About Medicago's pandemic flu vaccine candidate
Medicago's H5N1 vaccine candidate was formulated to protect against the Indonesian influenza virus. It is manufactured in Nicotiana benthamiana, a relative of the tobacco plant, using the Company's proprietary VLP technology. VLPs have several advantages over traditional flu vaccines. They are made to look like a virus, allowing them to be recognized readily by the body's immune system, however, they lack the core genetic material making them non-infectious and unable to replicate. Medicago's VLP-based vaccine has shown in preclinical studies it can provide protection against different strains of avian flu, such as the Vietnam and Turkey strains, and it may provide significant immune protection after a single dose. FDA-approved H5N1 influenza vaccines in the United States require two 90-microgram doses, administered at least four weeks apart to achieve appropriate level of antibodies in 44% of vaccinated individuals. Because Medicago's technology requires the genetic sequence of a viral strain and not the live influenza virus, vaccines can be manufactured within 4 weeks of obtaining the genetic sequence of a pandemic strain. This is in contrast with all current manufacturing technologies which rely on strain adaptation, a process that requires an additional 4-6 months before vaccine production can be initiated.
Source
Medicago
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