2009 H1N1 Vaccine Clinical Trial Results: Updates from NIAID

Ngày 12 Tháng Mười Một năm 2009

The government-sponsored clinical trials of the 2009 H1N1 influenza vaccine are well underway in healthy adults, children, people more than 65 years of age, pregnant women, people with asthma, and people infected with HIV.

Since August 2009, the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, has worked with more than 60 academic research centers to enroll thousands of volunteers in these trials. In collaboration with medical researchers conducting these trials and with our colleagues from CDC, FDA, and HHS, we are collecting, analyzing, and publicly disseminating the data from these trials as soon as they become available.

So far, NIAID trial results show most healthy volunteers mounted a strong immune response to one 15-microgram dose of vaccine. Children 9 years of age and younger mounted a strong immune response to two doses of the vaccine.

Most recently:

NIAID Director Anthony S. Fauci, M.D., updated a House Appropriations Subcommittee on NIH-supported research in the response to H1N1 flu. Read Dr. Fauci’s full testimony (PDF) or watch the hearing webcast (Windows Media Player).
NIAID announced that healthy pregnant women, who are at higher risk of flu complications, mounted a strong immune response to one dose of vaccine in clinical trials. Read the latest news release on early trial results and a Q and A on 2009 H1N1 vaccines for pregnant women.
An updated set of data from the trials confirmed that children 9 and younger need two 15-microgram doses of vaccine to achieve an immune response likely to protect them from illness, while children 10 and over need just one dose. The results support current U.S. vaccine recommendations. Read the latest news bulletin.

In addition, through regular reviews by an independent safety monitoring committee, data have shown no serious adverse events associated with the 2009 H1N1 flu vaccine. The production process for this vaccine is essentially the same as for seasonal influenza, which has an excellent safety record over the course of millions of doses and several decades. Every year, the seasonal flu vaccine is changed slightly to match the circulating virus, which is also how the 2009 H1N1 vaccine was made.

Want updates on all NIH 2009 H1N1 vaccine clinical trials now in progress? We update the NIAID 2009 H1N1 Clinical Trials Web page as soon we learn new information. Read more about specific trials at the following links, and sign up to be notified by email when these pages are updated: