Journal
JOURNAL OF INFECTIOUS DISEASES
Volume 203, Issue 12, Pages 1729-1738Publisher
OXFORD UNIV PRESS INC
DOI: 10.1093/infdis/jir172
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Funding
- GSK biologicals
- US Department of Health and Human Services
- Office of the Assistant Secretary for Preparedness and Response (ASPR)
- Biomedical Advanced Research and Development Authority (BARDA) [HHSO100200700029C]
- GlaxoSmithKline
- Wyeth
- Novartis
- Sanofi Pasteur
- Canadian Institutes of Health Research
- Public Health Agency of Canada
- Q&T Research Sherbrooke
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Methods. This phase III, placebo-controlled, observer-blinded study evaluated the immunogenicity, cross-reactivity, safety, and lot consistency of 2 doses of oil-in-water (AS03(A)) adjuvanted H5N1 A/Indonesia/05/2005 (3.75 mu g hemagglutinin antigen) prepandemic candidate vaccine in 4561 adults aged 18-91 years. Results. Humoral antibody responses in the H5N1 vaccine groups fulfilled US and European immunogenicity licensure criteria for pandemic vaccines in all age strata 21 days after the second dose. At 6 months after the administration of the primary dose, serum antibody seroconversion rates continued to fulfill licensure criteria. Neutralizing cross-clade immune responses were demonstrated against clade 1 A/Vietnam/1194/2004. Consistency was demonstrated for 3 consecutive H5N1 vaccine lots. Temporary injection-site pain was more frequent with H5N1 vaccine than placebo (89.3% and 70.7% in the 18-64 and >= 65 years strata vs 22.2% and 14.4% in the placebo groups). Unsolicited adverse event frequency, including medically attended and serious events, was similar between groups through day 364. Conclusions. In adults and elderly adults, AS03(A)-adjuvanted H5N1 candidate vaccine was highly immunogenic for A/Indonesia/05/2005, with cross-reactivity against A/Vietnam/1194/2004. Temporary injection site reactions were more frequent with H5N1 vaccine than placebo, although the H5N1 vaccine was well tolerated overall. Clinical Trials Registration. NCT00616928.
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