Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

NIH Begins Testing H7N9 Avian Influenza Vaccine Candidate

Published: Thursday, September 19, 2013
Last Updated: Thursday, September 19, 2013
Bookmark and Share
Researchers at nine sites nationwide have begun testing an investigational H7N9 avian influenza vaccine in humans.

The two concurrent Phase II clinical trials, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, are designed to gather critical information about the safety of the candidate vaccine and the immune system responses it induces when administered at different dosages and with or without adjuvants, substances designed to boost the body’s immune response to vaccination.

Human cases of H7N9 influenza first emerged in China in February 2013, with the majority of reported infections occurring in the spring. As of Aug. 12, 135 confirmed human cases, including 44 deaths, have been reported by the World Health Organization. Most of these cases involved people who came into contact with infected poultry. Although no H7N9 influenza cases have been reported outside of China and the virus has not demonstrated sustained person-to-person transmission, there is concern that it could mutate to pose a much greater public health threat.

“H7N9 avian influenza virus — like all novel influenza virus strains to which people have not been exposed — has the potential to cause widespread sickness and mortality,” said NIAID Director Anthony S. Fauci, M.D. “We are now testing a vaccine candidate with and without adjuvant in an effort to prepare for and, hopefully, protect against this possibility.”

The two clinical trials, which will enroll healthy adults ages 19 to 64, will evaluate an investigational H7N9 vaccine developed by Sanofi Pasteur. The candidate vaccine was made from inactivated H7N9 virus isolated in Shanghai, China in 2013. Adjuvants are being tested with the investigational vaccine because previous vaccine research involving other H7 influenza viruses has suggested that two doses of vaccine without adjuvant may not produce an immune response adequate to provide effective protection. In pandemic situations, adjuvants also can be used as part of a dose-sparing strategy, which would allow production of more doses of vaccine from the available supply of the viral antigen, thereby allowing a greater number of people to be vaccinated more quickly.

The first clinical trial, led by Mark J. Mulligan, M.D., of Emory University in Atlanta, will enroll as many as 700 study participants who will be randomly assigned to one of seven groups (up to 100 participants in each group). Each group will receive two equivalent dosages (3.75 micrograms [mcg], 7.5 mcg, 15 mcg or 45 mcg) of the candidate vaccine, approximately 21 days apart. Five of the groups will receive the vaccinations along with MF59 adjuvant, developed by Novartis Vaccines and Diagnostics.

Of these five groups, three will receive adjuvant with both vaccinations; one group of participants will receive adjuvant only with the first vaccination; and another group of participants will receive adjuvant only with the second vaccination. Two groups of participants will not receive adjuvant. The MF59 adjuvant that is being tested is also contained in the Fluad seasonal influenza vaccine currently licensed in Europe and Canada for use in people age 65 years or older.

The second trial, led by Lisa A. Jackson, M.D., M.P.H., of Group Health Research Institute in Seattle, will enroll as many as 1,000 participants. Each participant will be randomly assigned to one of 10 groups (up to 100 participants per group) and will receive two equivalent doses (same dosages as the other trial) of the investigational H7N9 vaccine given 21 days apart.

Seven of these groups will receive the vaccinations either with or without AS03 adjuvant, developed by GlaxoSmithKline Biologics. Two groups will receive their first vaccination with AS03 or MF59 adjuvant and then receive the alternate adjuvant at time of second vaccination. One group will receive the MF59 adjuvant at both vaccinations. The AS03 adjuvant that is being tested was used in a 2009 H1N1 influenza vaccine, Pandemrix, used in several European countries during the 2009-2010 H1N1 influenza pandemic.

In both studies, which are expected to conclude in December 2014, a panel of independent experts will closely monitor safety data at regular intervals throughout the trial.

The vaccine studies are being conducted at the eight NIAID-funded Vaccine and Treatment Evaluation Units: Baylor College of Medicine, Houston; Children’s Hospital Medical Center, Cincinnati; Emory University, Atlanta; Group Health Cooperative, Seattle; Saint Louis University, St. Louis; University of Iowa, Iowa City; University of Maryland School of Medicine, Baltimore; and Vanderbilt University, Nashville. The University of Texas Medical Branch at Galveston will conduct the trial as a subcontractor to Baylor College of Medicine.

Further information about both clinical trials can be found below using the identifiers: NCT01938742 and NCT01942265.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,500+ scientific posters on ePosters
  • More Than 5,000+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Developing Novel Ear Infection Treatments
Research team engineers antibiotic gel for treating middle ear infections.
Wednesday, September 28, 2016
“Sixth Sense” More Than a Feeling
NIH study of rare genetic disorder reveals importance of touch and body awareness.
Monday, September 26, 2016
“Sixth Sense” May Be More Than Just A Feeling
The NIH Study shows that two young patients with a mutation in the PIEZ02 have problems with touch and proprioception, or body awareness.
Friday, September 23, 2016
The Genetics of Blood Pressure
Researchers have identifed areas of the genome associated with blood-pressure including 17 previously unknown loci.
Wednesday, September 21, 2016
NIH Study Finds Link Between Depression, Gestational Diabetes
Researchers at NIH have discovered that the depression in early pregnancy doubles risk for gestational diabetes, and gestational diabetes increases risk for postpartum depression.
Tuesday, September 20, 2016
Detecting Bacterial Infections in Newborns
Researchers tested an alternative way to diagnose bacterial infections in infants—by analyzing RNA biosignatures from a small blood sample.
Wednesday, September 14, 2016
Finding Compounds That Inhibit Zika
Researchers identified compounds that inhibit the Zika virus and reduce its ability to kill brain cells.
Wednesday, September 14, 2016
Seeking Innovation to Combat Antimicrobial Resistance
Federal prize competition, with $20 million in prizes, seeks to develop new laboratory diagnostic tools to detect and distinguish antibiotic resistant bacteria.
Friday, September 09, 2016
Genetic Misdiagnoses of Heart Condition
Analysis found several genetic variations previously linked with a heart condition were harmless, leading to condition misdiagnosis.
Wednesday, September 07, 2016
Catalogue of Human Genetic Diversity Expands
The largest data set of human exomes to date has been assembled to better study seqence variants and their consequences.
Wednesday, September 07, 2016
Extreme Temperatures Could Increase Preterm Birth Risk
Researchers at NIH have found more preterm births among women exposed to extremes of hot and cold.
Friday, September 02, 2016
$12.4M Awarded to Neural Regeneration Projects
The National Institutes of Health will fund six projects to identify biological factors that influence neural regeneration.
Friday, September 02, 2016
Oxygen Can Impair Cancer Immunotherapy
Researchers have identified a mechanism within the lungs where anticancer immune resposnse is inhibited.
Friday, August 26, 2016
Diagnosing Bacterial Infections in Blood Samples
Researchers have diagnosed a bacterial infection from a blood sample in infants.
Wednesday, August 24, 2016
Stem Cell Therapy Heals Injured Mouse Brain
A team of researchers has developed a therapeutic technique that dramatically increases the production of nerve cells in mice with stroke-induced brain damage.
Tuesday, August 23, 2016
Scientific News
Point of Care Diagnostics - A Cautious Revolution
Advances in molecular biology, coupled with the miniaturization and improved sensitivity of assays and devices in general, have enabled a new wave of point-of-care (POC) or “bedside” diagnostics.
Mass Spec Technology Drives Innovation Across the Biopharma Workflow
With greater resolving power, analytical speed, and accuracy, new mass spectrometry technology and techniques are infiltrating the biopharmaceuticals workflow.
One Step Closer to Precision Medicine for Chronic Lung Disease Sufferers
A study led by University of North Carolina at Chapel Hill, and National Jewish Health, has provided evidence of links between SNPs and known COPD blood protein biomarkers.
Blood Pressure Drug May Boost Effectiveness of Lung Cancer Treatment
Researchers at Imperial College London have suggested that the blood pressure drug may make a type of lung cancer treatment more effective.
Insight into Eye Diseases
Scientists recreate zebrafish cell regeneration from retinal stem cells in mice.
New Discovery May Benefit Farmers Worldwide
Scientists have shown how a crop-microbe 'team' protect against fungal infection.
Antibodies Paving the Way to HIV Vaccine
Researchers uncover factors responsible for the formation of broadly neutralizing HIV antibodies in humans.
Designing Drugs with a Whole New Toolbox
Researchers develop methods to design small, targeted proteins with shapes not found in nature.
Protein Studies Discover Molecular Secrets
Two protein studies have mapped proteins that reveal the secrets to recycling carbon and healing cells.
Tapping Evolution to Improve Biotech Products
Researchers show how 'ancestral sequence reconstruction' can be used to guide engineering of a blood clotting protein.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!