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Title: Safety and immunogenicity of two different doses of a Vero cell-derived, whole virus clade 2 H5N1 (A/Indonesia/05/2005) influenza vaccine
Authors: Tambyah, P.A. 
Wilder-Smith, A. 
Pavlova, B.G.
Barrett, P.N.
Oh, H.M.L.
Hui, D.S.
Yuen, K.-Y.
Fritsch, S.
Aichinger, G.
Loew-Baselli, A.
van der Velden, M.
Maritsch, F.
Kistner, O.
Ehrlich, H.J.
Keywords: Avian influenza
Pandemic vaccine
Pre-pandemic vaccine
Issue Date: 5-Jan-2012
Citation: Tambyah, P.A., Wilder-Smith, A., Pavlova, B.G., Barrett, P.N., Oh, H.M.L., Hui, D.S., Yuen, K.-Y., Fritsch, S., Aichinger, G., Loew-Baselli, A., van der Velden, M., Maritsch, F., Kistner, O., Ehrlich, H.J. (2012-01-05). Safety and immunogenicity of two different doses of a Vero cell-derived, whole virus clade 2 H5N1 (A/Indonesia/05/2005) influenza vaccine. Vaccine 30 (2) : 329-335. ScholarBank@NUS Repository.
Abstract: A successful vaccine development strategy for areas with clustered H5N1 events requires conduct of vaccine trials in potentially non-naïve subjects and evaluation of post-vaccination responsiveness. An open-label, randomized, phase I/II study therefore assessed the immunogenicity and safety of two different dose levels of an inactivated, non-adjuvanted, whole virus clade 2.1 (A/Indonesia/05/2005) H5N1 Vero cell-derived influenza vaccine in healthy adults (21-45 years) from a region where the virus has been circulating (Hong Kong) as well as Singapore. Subjects (N=110) were randomized 1:1 to receive two vaccinations with either 3.75μg or 7.5μg H5N1 haemagglutinin antigen 21 days apart. Safety, immunogenicity (microneutralization [MN] and single radial haemolysis [SRH] at baseline and post-vaccination) and cross-reactivity against a heterologous clade 1 strain (A/Vietnam/1203/2004) of the vaccine were assessed. Pre-existing immunity to the vaccine strain was 14% which is higher than previously reported for these regions. Two vaccinations with either vaccine formulation induced high seroprotection rates (MN titre ≥ 1:20) against the vaccine strain A/Indonesia/05/2005: 82.7% and 86.5% in the 3.75μg and 7.5μg dose groups. Seroconversion rates and fold increase exceeded the CPMP criterion of >40% and >2.5 for MN and SRH in both dose groups after the second vaccination, while the seroprotection rate in the 7.5μg dose group determined by SRH was only marginally lower (69.2%) than the CPMP criterion of >70%. Thus, 11 of 12 CHMP criteria were fulfilled. A cross-reactive antibody response against the heterologous A/Vietnam/1203/2004 strain was demonstrated after the second vaccination (>21% by MN and ≥25% by SRH). Persistence of antibodies against the vaccine strain was also demonstrated 6 months after the first vaccination, indicating that a booster vaccination would be effective in those who have received two priming doses. No serious adverse events were reported. The H5N1 influenza vaccine against clade 2.1 strain A/Indonesia/05/2005 was well tolerated and immunogenic after two vaccinations, and induced a cross-neutralizing antibody response, with no dose effect. © 2011 Elsevier Ltd.
Source Title: Vaccine
ISSN: 0264410X
DOI: 10.1016/j.vaccine.2011.10.088
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