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Prime-Boost Interval Matters: A Randomized Phase 1 Study to Identify the Minimum Interval Necessary to Observe the H5 DNA Influenza Vaccine Priming Effect


Journal Article

Ledgerwood, J.E.; Zephir, K.; Hu, Z.; Wei, C.J.; Chang, L.; Enama, M.E.; Hendel, C.S.; Sitar, S.; Bailer, R.T.; Koup, R.A.; , ; Nabel, G.J.; Graham, B.S.; Team, T.V.R.C. 310 St

J Infect Dis




Antibodies; Avian influenza; boost interval; DNA; H5n1; hemagglutination inhibition; Hemagglutination Inhibition Tests; Hemagglutinin Glycoproteins; immunization; Influenza Vaccines; Influenza Virus/genetics/immunology; Vaccines Inactivated; Viral/blood

BACKGROUND: H5 DNA priming was previously shown to improve the antibody response to influenza A(H5N1) monovalent inactivated vaccine (MIV) among individuals for whom there was a 24-week interval between prime and boost receipt. This study defines the shortest prime-boost interval associated with an improved response to MIV. METHODS: We administered H5 DNA followed by MIV at intervals of 4, 8, 12, 16, or 24 weeks and compared responses to that of 2 doses of MIV (prime-boost interval, 24 weeks). RESULTS: H5 DNA priming with an MIV boost >/=12 weeks later showed an improved response, with a positive hemagglutination inhibition (HAI) titer in 91% of recipients (geometric mean titer [GMT], 141-206), compared with 55%-70% of recipients with an H5 DNA and MIV prime-boost interval of

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