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| Content Provider | World Health Organization (WHO)-Global Index Medicus |
|---|---|
| Author | Aichinger, Gerald Berezuk, Gregory Ehrlich, Hartmut J. Barrett, P. Noel Fritsch, Sandor El-amin, Wael Hart, Mary Kate Kistner, Otfried |
| Spatial Coverage | United States |
| Description | Author Affiliation: Barrett PN ( Global Research and Development, Baxter BioScience, Biomedical Research Centre, Orth/Donau, Austria. noel_barrett@baxter.com) |
| Abstract | BACKGROUND: The use of cell-culture technologies for the manufacture of influenza vaccines might contribute to improved strain selection and robust vaccine supplies. We investigated the safety, immunogenicity, and protective efficacy of a Vero-cell-culture-derived influenza vaccine, and assessed the correlation between vaccine efficacy and haemagglutination inhibition antibody titre. METHODS: In a double-blind, placebo-controlled, phase 3 trial undertaken in 36 centres in the USA, healthy adults (aged 18-49 years) were randomly assigned in a 1:1 ratio to one injection of either placebo or Vero-cell-culture-derived influenza vaccine during the 2008-09 season. Randomisation was done in blocks by use of the random number generator algorithm, and participants were allocated by use of a centralised telephone system. The primary objective was the efficacy of the vaccine in preventing cell-culture-confirmed influenza infection with viruses that were antigenically matched to one of the vaccine strains. Analysis was by intention to treat. The study is registered with ClinicalTrials.gov, number NCT00566345. FINDINGS: 7250 participants were randomly assigned to vaccine (n=3626) and placebo (n=3624). 7236 were analysed for the primary outcome (n=3619 and n=3617, respectively). Overall protective efficacy for antigenically matched influenza infection was 78·5% (95% CI 60·8-88·2). The vaccine was well tolerated with no treatment-related serious adverse events. Adverse events were mainly mild and transient. An HI titre of at least 1:15 provided a reliable correlate of cell-culture-derived influenza vaccine-induced protection; no additional benefit was noted with titres greater than 1:30. INTERPRETATION: The data indicate that existing correlates of protection afforded with egg-derived seasonal influenza vaccines also apply to this vaccine. FUNDING: Federal (US Government) funds from the Office for Preparedness and Response, Biomedical Advanced Research and Development Authority, under contract to DynPort Vaccine Company. |
| ISSN | 01406736 |
| e-ISSN | 1474547X |
| Journal | The Lancet |
| Issue Number | 9767 |
| Volume Number | 377 |
| Language | English |
| Publisher | Elsevier |
| Publisher Date | 2011-02-26 |
| Publisher Place | Great Britain (UK) |
| Access Restriction | Open |
| Subject Keyword | Influenza Vaccines Immunology Influenza, Human Prevention & Control Vero Cells Animals Cercopithecus Aethiops Double-Blind Method Hemagglutination Inhibition Tests Influenza A Virus, H1N1 Subtype Administration & Dosage Adverse Effects Chemically Induced ROC Curve Risk Assessment Sensitivity And Specificity Multicenter Study Randomized Controlled Trial Research Support, U.S. Gov't, P.H.S. Medicine |
| Content Type | Text |
| Resource Type | Article |
| Subject | Medicine |
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