1.		What clinical trials of 2009 H1N1 influenza vaccine is NIAID sponsoring?
		The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring several clinical trials of 2009 H1N1 influenza vaccine in various populations. The trials include people of nearly all ages.  They include healthy people as well as individuals with underlying health conditions, specifically, certain people who have asthma or who are HIV-positive.  Brief descriptions of these trials, and links for additional information, follow. Healthy, non-pregnant adults 18 years and older 1. Trial comparing two different strengths and one and two doses of 2009 H1N1 influenza vaccine produced by Sanofi Pasteur. This trial has enrolled approximately 400 volunteers. Details about the design of this trial are available at NCT00943631. 2. Trial comparing two different strengths and one and two doses of 2009 H1N1 flu vaccine produced by CSL Limited. This trial has enrolled approximately 400 volunteers. Details about the design of this trial are available at NCT00943488. 3. Trial comparing simultaneous and sequential administration of seasonal flu vaccine and 2009 H1N1 influenza vaccine produced by Sanofi Pasteur. This trial has enrolled approximately 800 volunteers. Details about the design of this trial are available at NCT00943878. 4. Trial testing 2009 H1N1 influenza vaccine produced by Sanofi Pasteur and an adjuvant made by GlaxoSmithKline (GSK). (Adjuvants are substances added to vaccine to boost the body’s immune response to the vaccine.) This trial will enroll approximately 750 volunteers. A Questions and Answers document about this trial is available. Details about the design of the trial are available at NCT00963157. Healthy children aged 6 months through 17 years old 5. Trial comparing two different strengths and one and two doses of 2009 H1N1 flu vaccine produced by Sanofi Pasteur. This trial has enrolled approximately 600 children. Details about the design of this trial are available at NCT00944073. 6. Trial comparing simultaneous and sequential administration of seasonal flu vaccine and 2009 H1N1 influenza vaccine produced by Sanofi Pasteur. This trial has enrolled approximately 600 volunteers. Details about the design of this trial are available at NCT00943202. A Questions and Answers document about the trials in children is available. Healthy pregnant women 7. Trial comparing two different strengths and one and two doses of 2009 H1N1 flu vaccine produced by Sanofi Pasteur. This trial has enrolled approximately 120 women in the second or third trimester of pregnancy. A Questions and Answers document about this trial is available. Details about the design of this trial are available at NCT 0093430. People with asthma 8. Trial comparing two different strengths and one and two doses of 2009 H1N1 influenza vaccine manufactured by Novartis. This trial is cosponsored by NIAID and the National Heart, Lung and Blood Institute (NHLBI). It will enroll up to 350 people aged 12 years and older who have mild, moderate or severe asthma. A Questions and Answers document about this trial is available. Details about the design of this trial are available at NCT00978120.  Children, youth and pregnant women who have HIV infection 9. Trials testing two doses of 2009 H1N1 vaccine produced by Novartis. These trials are cosponsored by NIAID and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). One trial will enroll approximately 130 HIV-positive pregnant women in the second or third trimester of pregnancy. Details about the design of this trial are at NCT00992017. One trial will enroll approximately 140 people aged 4 to 24 years old who were infected with HIV at birth. Details about the design of this trial are available at NCT00992836.  A Questions and Answers document about these trials is available.
2.		What key questions are the trials designed to answer?
		Are these vaccines safe in people of various ages, in women who are pregnant, and in people with underlying health conditions, such as asthma or HIV infection? How large a vaccine dose, and how many doses of vaccine, is needed to induce an immune response that is predictive of protection in these various populations? Can 2009 H1N1 influenza vaccine be safely administered at the same time or sequentially with the seasonal flu vaccine, and will both vaccines induce protective immune responses?
3.		To date, what have you learned from these trials?
		Encouraging early results from some trials have come in and have been announced publicly.  The vaccine generally has been found to be safe and well-tolerated, and the vaccine has stimulated immune responses likely to be protective.  Specifically, the following information has been announced. Sept. 11: Healthy adults who received a single 15-microgram dose of 2009 H1N1 vaccine had robust immune responses 8 to 10 days following the first dose of vaccine. Sept. 21: Healthy children older than 9 years had a robust immune response following a single 15-microgram dose of 2009 H1N1 vaccine. Children younger than 9 are likely to need two doses of vaccine to be protected. Oct. 9: In healthy adults, co-administration of the seasonal and 2009 H1N1 flu vaccines did not impair the immune response to either one.  Nov. 2: Early results from a trial in healthy pregnant women showed that one dose of 2009 H1N1 vaccine elicits a strong immune response.
4.		Is it possible to become infected with 2009 H1N1 influenza virus by receiving the vaccine?
		No. All the 2009 H1N1 vaccines being administered in these trials contain an inactivated (killed) form of the 2009 H1N1 virus. It is impossible to become infected with the virus by receiving the vaccine.
5.		How is the safety of volunteers in these trials being ensured?
		Safety is being closely monitored throughout the trials, both by the study investigators and by an independent panel of experts known as a Safety Monitoring Committee. The SMC is convened by NIAID to review the data from all NIAID-sponsored 2009 H1N1 influenza vaccine trials. The committee reviews safety data to look for patterns in the data that would affect the well-being of people in the trial. The committee has the authority to make recommendations to modify or stop trials based on the safety data.
6.		How do scientists evaluate the performance of the vaccines in these trials?
		To evaluate the immune response of the vaccines in these trials, the researchers look at the level of antibodies induced by the vaccines in the volunteers using two assays: Hemagglutinin inhibition assay (a laboratory test used to measure the amount of antibody present in a sample by determining if the antibody inhibits influenza virus from attaching to red blood cells) Microneutralization assay (a technique used to determine if the level of antibody in the sample inhibits the virus from infecting cells grown in the laboratory)
7.		Where are the trials taking place?
		The trials in healthy populations (adults, pregnant women and children) are being conducted through the national network of NIAID-funded Vaccine and Treatment Evaluation Units (VTEUs). There are eight VTEUs located at the following sites: 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 In addition to the eight VTEU locations, some NIAID trials are also enrolling volunteers at additional locations. The NIAID-NHLBI trial of 2009 H1N1 influenza vaccine in people with asthma is enrolling volunteers at seven locations. Cleveland Clinic, Ohio Emory University, Atlanta University of Pittsburgh Asthma Institute University of Virginia, Charlottesville University of Wisconsin, Madison Wake Forest University, Winston-Salem, N.C. Washington University School of Medicine, St. Louis The NIAID-NICHD trials of 2009 H1N1 influenza vaccine in HIV-positive children, youth and pregnant women are enrolling volunteers at 43 sites in the United States and Puerto Rico.

Media inquiries can be directed to the NIAID Office of Communications at 301-402-1663, niaidnews@niaid.nih.gov.