Jul 22, 2009 (CIDRAP News) – Federal health officials today announced plans to launch several clinical trials of pandemic H1N1 vaccines in a race to gather safety and immunogenicity data in time for a possible fall resurgence of the novel virus. In some of the trials, volunteers will receive H1N1 and seasonal flu shots at the same time.
In a news release, the National Institute of Allergy and Infectious Diseases (NIAID) said the trials will be conducted at its eight Vaccine and Treatment Evaluation Units at academic medical centers around the country. The vaccines for the trials are being made by CSL Biotherapies and Sanofi Pasteur.
Federal health officials hope to make the first H1N1 vaccine doses available as early as possible in the fall, possibly October, leaving little time to test them. They are also concerned about the prospect of trying to vaccinate millions of people against H1N1 and seasonal flu at the same time or in a short time frame, though the seasonal vaccine is expected to be available sooner.
"The trials are being conducted in a compressed time frame in a race against the possible autumn resurgence of 2009 H1N1 flu infections that may occur at the same time as seasonal influenza virus strains begin to circulate widely in the Northern Hemisphere," the NIAID said.
It said results from the trials are expected to be available "weeks after the trials begin."
The agency said one set of trials will assess the immune response to one or two 15-microgram (mcg) doses and one or two 30-mcg doses in healthy adults (aged 18 to 64) and elderly people (65 and older). The doses will be given 21 days apart. If early results indicate the vaccines are safe, similar trials in healthy children will be launched.
Another set of trials will look at the safety and immune response in healthy adults and elderly people given the seasonal flu vaccine along with a 15-mcg dose of H1N1 vaccine. The latter vaccine will be given to different sets of volunteers before, after, or at the same time as the seasonal vaccine.
A panel of outside experts will closely review the safety data from the trials "to spot any safety concerns in real time," the NIAID said. The trial results will be used to develop recommendations for different age and risk groups
The NIAID said it collaborated closely with the FDA and the Biomedical Advanced Research and Development Agency to launch the trials quickly while maintaining high standards.
The institutions conducting the trials are
- 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
- Vanderbilt University, Nashville
The NIAID announcement came as the Food and Drug Administration's vaccine advisory committee prepared to meet tomorrow to discuss H1N1 vaccine issues. A briefing document the FDA prepared for the meeting says that decisions about vaccine formulation and use may have to be based on limited or even no clinical trial data.
Because surveillance data may indicate a need to start an H1N1 vaccination campaign before much testing is done, the document states, "We recognize that the regulatory approach needs to be flexible and that policy decisions regarding vaccine formulation and use may have to be based on results from incomplete or smaller clinical studies or even in the absence of clinical data with novel influenza A (H1N1) vaccine."
The document was prepared for the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC).
Jul 22 NIAID news release