Efficacy, safety, and immunogenicity of a Vero-cell-culture-derived trivalent influenza vaccine: a multicentre, double-blind, randomised, placebo-controlled trial

Summary 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 asses...

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Bibliographic Details
Published in:The Lancet (British edition) 2011, Vol.377 (9767), p.751-759
Main Authors: Barrett, P Noel, Dr, Berezuk, Gregory, MS, Fritsch, Sandor, PhD, Aichinger, Gerald, MD, Hart, Mary Kate, PhD, El-Amin, Wael, MD, Kistner, Otfried, PhD, Ehrlich, Hartmut J, MD
Format: Article
Language:English
Subjects:
Adult
adults
Algorithms
Animals
Antibodies
Biological and medical sciences
cell culture
Cercopithecus aethiops
Clinical medicine
Data collection
Data processing
Double-Blind Method
Female
General aspects
hemagglutination
Hemagglutination Inhibition Tests
Human viral diseases
Humans
Illnesses
Immunogenicity
Infection
Infectious diseases
Influenza
Influenza A Virus, H1N1 Subtype - immunology
Influenza Vaccines - administration & dosage
Influenza Vaccines - adverse effects
Influenza Vaccines - immunology
Influenza, Human - chemically induced
Influenza, Human - immunology
Influenza, Human - prevention & control
Internal Medicine
Male
manufacturing
Medical sciences
Middle Aged
Motivation
Prevention and actions
Public health. Hygiene
Public health. Hygiene-occupational medicine
R&D
Research & development
research and development
Risk Assessment
ROC Curve
Sensitivity and Specificity
Studies
Technological change
Treatment Outcome
United States
Vaccines
Vero Cells
Viral diseases
Viral diseases of the respiratory system and ent viral diseases
viruses
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Summary:Summary 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:0140-6736
1474-547X
DOI:10.1016/S0140-6736(10)62228-3