Journal article
Randomized clinical trial of immunogenicity and safety of a recombinant H1N1/2009 pandemic influenza vaccine containing Advax™ polysaccharide adjuvant
DL Gordon, D Sajkov, RJ Woodman, Y Honda-Okubo, MMJ Cox, S Heinzel, N Petrovsky
Vaccine | Published : 2012
Abstract
Background: Timely vaccine supply is critical during influenza pandemics. A recombinant hemagglutinin (rHA)-based vaccine could overcome production hurdles of egg-based vaccines but has never previously been tested in a real-life pandemic setting. The primary aim was to determine the efficacy of a recombinant pandemic vaccine and whether its immunogenicity could be enhanced by a novel polysaccharide adjuvant (Advax™). Methods: 281 adults aged 18-70 years were recruited in a randomized, subject and observer blinded, parallel-group study of rHA H1N1/2009 vaccine with or without adjuvant. Immunizations were at 0 and 3 weeks with rHA 3, 11 or 45 μg. Serology and safety was followed for 6 months...
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Awarded by National Institutes of Health
Funding Acknowledgements
We thank Dr. Nancy Cox (Centers for Disease Control and Prevention, Atlanta, GA) and Dr. Jesse Goodman (US Food and Drug Administration, Rockville, MD) for the expedited availability of the novel H1N1 virus strain. We thank the clinical trial coordinators and research staff including Sharen Pringle, Brigit McAteer, Kylie Bragg, Lynda Borg, Susan Virgin, Lyndall Stone, Frances Kissajukian and Melody Vrakking for their expert assistance. We thank all the study participants for their voluntary participation in the study. Reference ferret sera to H1N1/A/California/07/2009 was provided by the Biodefense and Emerging Infections (BEI) Research Resources Repository, NIH. Development of Advax (TM) adjuvant was supported by Contracts U01-AI061142 and HHSN272200800039 C from the National Institutes of Health, National Institute of Allergy and Infectious Diseases. This publication's contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health, National Institute of Allergy and Infectious Diseases. This work was supported by National Institutes of Health [Contracts AI061142 and HHSN272200800039C].