jueves, 10 de diciembre de 2015

Media Availability: Prime-Boost H7N9 Influenza Vaccine Concept Promising in Clinical Trial

Media Availability: Prime-Boost H7N9 Influenza Vaccine Concept Promising in Clinical Trial







Prime-Boost H7N9 Influenza Vaccine Concept Promising in Clinical Trial

H7N9 influenza emerged in spring 2013 in China and has been identified as having pandemic potential. Through mid-November the World Health Organization has reported 681 confirmed cases with at least 275 deaths. H7N9 influenza has not been found in the United States. In a two-step clinical study of a candidate H7N9 influenza vaccine, NIAID scientists showed that a “primer” vaccine could be used in people to introduce the immune system to the virus weeks in advance of natural exposure to the virus, at which time a “booster” vaccine could be successfully used to recall a more robust immune response. Clinical researchers at the University of Rochester administered the vaccines and monitored 65 volunteers. MedImmune, a Maryland company, created the live attenuated candidate H7N9 vaccine as part of a cooperative research and development agreement with NIAID.

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MEDIA AVAILABILITY

Prime-Boost H7N9 Influenza Vaccine Concept Promising in Clinical Trial

WHAT:
In clinical trials, several candidate H7N9 pandemic influenza vaccines made from inactivated viruses have been shown to be safe and to generate an immune response. However, scientists believe for practical use, these potential vaccines would require multiple doses or the addition of adjuvants, which enhance the immune response. With hopes of making one dose of an inactivated H7N9 vaccine fully protective, scientists from the National Institute of Allergy and Infectious Diseases (NIAID) successfully tested a prime-boost concept in a small clinical trial.  The “primer” pandemic influenza vaccine—made from live but weakened virus—introduces the immune system to H7N9 influenza virus, and subsequent vaccination with the “booster” inactivated virus vaccine recalls a more robust immune response.

H7N9 influenza emerged in spring 2013 in China, primarily affecting people who have close contact with poultry. Through Nov. 13, 2015, the World Health Organization has reported 681 confirmed cases with at least 275 deaths. H7N9 influenza has not been found in the United States.

The studyExternal Web Site Policy, which appears in The Journal of Infectious Diseases, included 65 volunteers, 48 aged 18-49 years and 17 aged 50-70 years. Studies of live pandemic influenza vaccines in the older group had not been done before and are important because that is the age group most susceptible to severe disease from H7N9 influenza. Clinical researchers at the University of Rochester administered the vaccines and monitored volunteers. MedImmune, a Maryland company, created the live attenuated candidate H7N9 vaccine as part of a cooperative research and development agreement with NIAID. The Biomedical Advanced Research and Development Authority of the Department of Health and Human Services also supported the study.

Scientists designed the H7N9 clinical study after similar trials with other pandemic influenza viruses. Volunteers received either one or two doses of the candidate live attenuated vaccine and then 12 weeks later received an inactivated H7N9 vaccine, manufactured by Sanofi Pasteur (Swiftwater, Pennsylvania). The live attenuated vaccine primer created strong immune memory in both age groups, regardless of whether volunteers received one or two doses. Both vaccines were well tolerated.

Whether the live-virus vaccine used alone would provide protection without the inactivated vaccine boost remains a question. Scientists do know, however, that live-attenuated influenza vaccines developed against H5N1, H7N7, and now H7N9 generate long-lasting immunity that is rapidly recalled by a dose of inactivated vaccine.

ARTICLE:
M. Sobhanie et alEvaluation of the safety and immunogenicity of a candidate pandemic live attenuated influenza vaccine (pLAIV) against H7N9 influenzaExternal Web Site PolicyThe Journal of Infectious Diseases DOI: 10.1093/infdis/jiv526 (2015).

WHO:
Influenza expert Kanta Subbarao, M.B.B.S., M.P.H., chief of the Emerging Respiratory Viruses Section in the NIAID Laboratory of Infectious Diseases, and NIAID Director Anthony S. Fauci, M.D., are available to discuss this study.

CONTACT:
To schedule interviews, please contact Ken Pekoc, (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 website.
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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