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  • Tambyah, Paul A (author)

Safety and immunogenicity of two different doses of a Vero cell-derived, whole virus clade 2 H5N1 (A/Indonesia/05/2005) influenza vaccine.

  • Article/chapterEnglish2012

Publisher, publication year, extent ...

  • Elsevier,2012
  • printrdacarrier

Numbers

  • LIBRIS-ID:oai:DiVA.org:umu-53184
  • https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-53184URI
  • https://doi.org/10.1016/j.vaccine.2011.10.088DOI

Supplementary language notes

  • Language:English
  • Summary in:English

Part of subdatabase

Classification

  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • 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.

Subject headings and genre

Added entries (persons, corporate bodies, meetings, titles ...)

  • Wilder-Smith, AnneliesInstitute of Public Health, University of Heidelberg, Germany(Swepub:umu)anwi0099 (author)
  • Pavlova, Borislava G (author)
  • Barrett, P Noel (author)
  • Oh, Helen M L (author)
  • Hui, David S (author)
  • Yuen, Kwok-yung (author)
  • Fritsch, Sandor (author)
  • Aichinger, Gerald (author)
  • Loew-Baselli, Alexandra (author)
  • van der Velden, Maikel (author)
  • Maritsch, Friedrich (author)
  • Kistner, Otfried (author)
  • Ehrlich, Hartmut J (author)
  • Institute of Public Health, University of Heidelberg, Germany (creator_code:org_t)

Related titles

  • In:Vaccine: Elsevier30:2, s. 329-350264-410X1873-2518

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