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Safety and immunoge...
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Tambyah, Paul A
(författare)
Safety and immunogenicity of two different doses of a Vero cell-derived, whole virus clade 2 H5N1 (A/Indonesia/05/2005) influenza vaccine.
- Artikel/kapitelEngelska2012
Förlag, utgivningsår, omfång ...
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Elsevier,2012
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printrdacarrier
Nummerbeteckningar
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LIBRIS-ID:oai:DiVA.org:umu-53184
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https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-53184URI
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https://doi.org/10.1016/j.vaccine.2011.10.088DOI
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Språk:engelska
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Sammanfattning på:engelska
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Ämneskategori:art swepub-publicationtype
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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 3.75 μg or 7.5 μg 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 3.75 μg and 7.5 μg 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 7.5 μg 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.
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Wilder-Smith, AnneliesInstitute of Public Health, University of Heidelberg, Germany(Swepub:umu)anwi0099
(författare)
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Pavlova, Borislava G
(författare)
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Barrett, P Noel
(författare)
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Oh, Helen M L
(författare)
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Hui, David S
(författare)
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Yuen, Kwok-yung
(författare)
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Fritsch, Sandor
(författare)
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Aichinger, Gerald
(författare)
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Loew-Baselli, Alexandra
(författare)
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van der Velden, Maikel
(författare)
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Maritsch, Friedrich
(författare)
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Kistner, Otfried
(författare)
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Ehrlich, Hartmut J
(författare)
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Institute of Public Health, University of Heidelberg, Germany
(creator_code:org_t)
Sammanhörande titlar
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Ingår i:Vaccine: Elsevier30:2, s. 329-350264-410X1873-2518
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Vaccine
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Tambyah, Paul A
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Barrett, P Noel
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Hui, David S
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Yuen, Kwok-yung
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Fritsch, Sandor
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Aichinger, Geral ...
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Kistner, Otfried
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