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Hum Vaccin Immunother. 2015 Apr 1:0. [Epub ahead of print]
H2n2 live attenuated influenza vaccine is safe and immunogenic for healthy adult volunteers.
Isakova-Sivak I1, Stukova M, Erofeeva M, Naykhin A, Donina S, Petukhova G, Kuznetsova V, Kiseleva I, Smolonogina T, Dubrovina I, Pisareva M, Nikiforova A, Power M, Flores J, Rudenko L.
Author information
Abstract
H2N2 influenza viruses have not circulated in human population since 1968, while they are still being regularly detected in animal reservoir, suggesting their high pandemic potential. To prepare for possible H2N2 pandemic, a number of H2N2 vaccine candidates have been generated and tested in preclinical and clinical studies. Here we describe the results of a randomized, double-blind placebo-controlled phase 1 clinical trial of H2N2 live attenuated influenza vaccine (LAIV) candidate prepared from a human influenza virus isolated in 1966. The vaccine was safe and well-tolerated by healthy adults, did not cause serious adverse events or an increased rate of moderate or severe reactogenicities. The H2N2 vaccine virus was infectious for humans: it was shed by 78.6% and 74.1% volunteers after the first and second dose, respectively, most probably due to the human origin of the virus. Importantly, no vaccine virus transmission to unvaccinated subjects was detected during the study. We employed multiple immunological tests to ensure the adequate assessment of the H2N2 pandemic LAIV and demonstrated that the majority (92.6%) of the vaccinated subjects responded to the H2N2 LAIV in one or more immunological tests, including 85.2% of subjects with antibody responses and 55.6% volunteers with cell-mediated immune responses. In addition, here we observed strong correlation between the H2N2 LAIV virus replication in upper respiratory tract and the development of antibody responses.
KEYWORDS:
clinical trial; immunogenicity; influenza H2N2; live attenuated influenza vaccine; pandemic; safety; transmissibility; vaccine virus shedding
PMID: 25831405 [PubMed - as supplied by publisher]
H2n2 live attenuated influenza vaccine is safe and immunogenic for healthy adult volunteers.
Isakova-Sivak I1, Stukova M, Erofeeva M, Naykhin A, Donina S, Petukhova G, Kuznetsova V, Kiseleva I, Smolonogina T, Dubrovina I, Pisareva M, Nikiforova A, Power M, Flores J, Rudenko L.
Author information
Abstract
H2N2 influenza viruses have not circulated in human population since 1968, while they are still being regularly detected in animal reservoir, suggesting their high pandemic potential. To prepare for possible H2N2 pandemic, a number of H2N2 vaccine candidates have been generated and tested in preclinical and clinical studies. Here we describe the results of a randomized, double-blind placebo-controlled phase 1 clinical trial of H2N2 live attenuated influenza vaccine (LAIV) candidate prepared from a human influenza virus isolated in 1966. The vaccine was safe and well-tolerated by healthy adults, did not cause serious adverse events or an increased rate of moderate or severe reactogenicities. The H2N2 vaccine virus was infectious for humans: it was shed by 78.6% and 74.1% volunteers after the first and second dose, respectively, most probably due to the human origin of the virus. Importantly, no vaccine virus transmission to unvaccinated subjects was detected during the study. We employed multiple immunological tests to ensure the adequate assessment of the H2N2 pandemic LAIV and demonstrated that the majority (92.6%) of the vaccinated subjects responded to the H2N2 LAIV in one or more immunological tests, including 85.2% of subjects with antibody responses and 55.6% volunteers with cell-mediated immune responses. In addition, here we observed strong correlation between the H2N2 LAIV virus replication in upper respiratory tract and the development of antibody responses.
KEYWORDS:
clinical trial; immunogenicity; influenza H2N2; live attenuated influenza vaccine; pandemic; safety; transmissibility; vaccine virus shedding
PMID: 25831405 [PubMed - as supplied by publisher]