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Safety and immunoge...
Safety and immunogenicity of two different doses of a Vero cell-derived, whole virus clade 2 H5N1 (A/Indonesia/05/2005) influenza vaccine.
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Tambyah, Paul A (författare)
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- Wilder-Smith, Annelies (författare)
- Institute of Public Health, University of Heidelberg, Germany
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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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(creator_code:org_t)
- Elsevier, 2012
- 2012
- Engelska.
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Ingår i: Vaccine. - : Elsevier. - 0264-410X .- 1873-2518. ; 30:2, s. 329-35
- Relaterad länk:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap -- Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences -- Public Health, Global Health, Social Medicine and Epidemiology (hsv//eng)
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Tambyah, Paul A
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Wilder-Smith, An ...
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Pavlova, Borisla ...
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Barrett, P Noel
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Oh, Helen M L
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Hui, David S
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visa fler...
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Yuen, Kwok-yung
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Fritsch, Sandor
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Aichinger, Geral ...
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Loew-Baselli, Al ...
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van der Velden, ...
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Maritsch, Friedr ...
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Kistner, Otfried
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Ehrlich, Hartmut ...
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