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August 18, 2009

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BULLETIN

NIAID to Begin Trials
of Candidate H1N1 Vaccines in Children

Independent Monitoring Committee Gives Go-Ahead After
Initial Review of Safety Data


The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced today that an independent safety monitoring committee has recommended that trials of a candidate 2009 H1N1 vaccine begin in children. NIAID concurred with this recommendation. Vaccinations will begin shortly in two trials being conducted through NIAID’s nationwide network of Vaccine and Treatment Evaluation Units (VTEU).

The safety monitoring committee reviewed data from more than 500 healthy adult and elderly volunteers enrolled in three VTEU trials of candidate H1N1 vaccines that began Aug. 7, 2009. The committee found no safety concerns in those trials that would preclude trials from proceeding in children.

Trial 1: Two Strengths of 2009 H1N1 Vaccine

One trial will test the immune responses to two different strengths of a candidate 2009 H1N1 vaccine manufactured by sanofi pasteur (Swiftwater, PA). This trial, led by the VTEU at the University of Maryland, Baltimore, will enroll up to 650 children aged six months to 17 years at five locations. Volunteers will receive a dose of either 15 micrograms or 30 micrograms of H1N1 vaccine at their first visit and a second dose three weeks later. Study investigators will take blood samples, which will show how the immune system responds (for example, by making antibodies against H1N1 virus) at set time points following the first and second injections. In addition to the VTEU at University of Maryland, the VTEU at Vanderbilt University, Nashville, TN, will participate in this trial along with sites at Duke University, Durham, NC; Children’s Mercy Hospital, Kansas City, MO; and Children’s Hospital, Seattle.

Trial 2:  Seasonal Influenza Vaccine Plus 2009 H1N1 Vaccine

The VTEU at Saint Louis University is leading a second trial testing the candidate sanofi pasteur vaccine together with a licensed seasonal influenza vaccine. The trial will enroll up to 650 children aged six months to 17 years at Saint Louis University and five additional locations nationwide. It will assess the candidate vaccine’s safety and also how immune responses vary when the H1N1 vaccine is given before, after or at the same time as the seasonal flu vaccine. Other participating sites are the VTEUs at Baylor College of Medicine, Houston; Cincinnati Children’s Hospital; Emory University, Atlanta; and the University of Iowa, Iowa City. In addition to those VTEUs, the University of Texas Medical Branch at Galveston also will enroll volunteers in this trial.

The sanofi pasteur candidate 2009 H1N1 flu vaccine contains inactivated (killed) virus. It is impossible to become infected with 2009 H1N1 flu virus by receiving this vaccine.

Safety data will be assessed continuously throughout the two trials by the study investigators and by the independent safety monitoring committee. Initial results on how the immune system responds to the vaccine are expected in the next several weeks.

Further information about the trials can be found at ClinicalTrials.gov at the following links:

  • 09-0054 Unadjuvanted Sanofi Pasteur H1N1 Influenza Vaccine Administered at Two Dose Levels to Children
  • 09-0047 Licensed Seasonal Flu Vaccine Given Together or Sequentially with Unadjuvanted Sanofi Pasteur H1N1 Influenza Vaccine in Previously Primed Children

For more information about the 2009 H1N1 clinical trials, see Questions and Answers: Pediatric Trials of Candidate 2009 H1N1 Vaccine at NIAID Vaccine and Treatment Evaluation Units (VTEUs) and Questions and Answers: Clinical Trials of 2009 H1N1 Influenza Vaccines Conducted by the NIAID-Supported Vaccine and Treatment Evaluation Units.

For more information on influenza, visit www.flu.gov for one-stop access to U.S. government information on avian and pandemic influenza. Also, visit NIAID's Flu Portal.

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


NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at www.niaid.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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Last Updated August 18, 2009