Giuseppe
Emeritus
[Source: The Journal of Infectious Diseases, full text: (LINK). Abstract, edited.]
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Boost Interval Matters: A Randomized Phase I Study to Identify the Minimum Interval to Observe the H5DNA Influenza Vaccine Priming Effect
Julie E. Ledgerwood 1,*, Kathryn Zephir 1, Zonghui Hu 2, Chih-Jen Wei 1, LeeJah Chang 1, Mary E. Enama 1, Cynthia S. Hendel 1, Sandra Sitar 1, Robert T. Bailer 1, Richard A. Koup 1, John R. Mascola 1, Gary J. Nabel 1, Barney S. Graham 1, the VRC 310 Study Team
Author Affiliations: <SUP>1</SUP>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892 <SUP>2</SUP>Biostatistics Research Branch, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892
*To whom correspondence should be addressed. Julie E. Ledgerwood, Phone: 301-594-8502; Fax: 301-480-2771; Email: Ledgerwood@mail.nih.gov
Abstract
Background.
H5DNA priming was previously shown to improve antibody response to H5N1 monovalent inactivated vaccine (MIV) with a 24-week interval. This study defines the shortest prime-boost interval with improved response.
Methods.
We administered H5DNA followed 4, 8, 12, 16, or 24 weeks by MIV as compared to two doses of MIV (24-week).
Results.
H5DNA priming with ≥12 week MIV boost showed improved response, with positive HAI in 91% [geometric mean titer (GMT) 141-206]; compared to ≤8-week boost (55-70%; GMT 51-70) or MIV-MIV 24-week boost (44% ; GMT 27).
Conclusions.
H5DNA priming enhances antibody responses after an MIV boost when the interval is 12-24 weeks.
Received November 29, 2012. Revision received January 31, 2013. Accepted February 6, 2013.
Published by Oxford University Press on behalf of the Infectious Diseases Society of America 2013.
-Julie E. Ledgerwood 1,*, Kathryn Zephir 1, Zonghui Hu 2, Chih-Jen Wei 1, LeeJah Chang 1, Mary E. Enama 1, Cynthia S. Hendel 1, Sandra Sitar 1, Robert T. Bailer 1, Richard A. Koup 1, John R. Mascola 1, Gary J. Nabel 1, Barney S. Graham 1, the VRC 310 Study Team
Author Affiliations: <SUP>1</SUP>Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892 <SUP>2</SUP>Biostatistics Research Branch, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892
*To whom correspondence should be addressed. Julie E. Ledgerwood, Phone: 301-594-8502; Fax: 301-480-2771; Email: Ledgerwood@mail.nih.gov
Abstract
Background.
H5DNA priming was previously shown to improve antibody response to H5N1 monovalent inactivated vaccine (MIV) with a 24-week interval. This study defines the shortest prime-boost interval with improved response.
Methods.
We administered H5DNA followed 4, 8, 12, 16, or 24 weeks by MIV as compared to two doses of MIV (24-week).
Results.
H5DNA priming with ≥12 week MIV boost showed improved response, with positive HAI in 91% [geometric mean titer (GMT) 141-206]; compared to ≤8-week boost (55-70%; GMT 51-70) or MIV-MIV 24-week boost (44% ; GMT 27).
Conclusions.
H5DNA priming enhances antibody responses after an MIV boost when the interval is 12-24 weeks.
Received November 29, 2012. Revision received January 31, 2013. Accepted February 6, 2013.
Published by Oxford University Press on behalf of the Infectious Diseases Society of America 2013.
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