期刊
VACCINE
卷 30, 期 36, 页码 5407-5416出版社
ELSEVIER SCI LTD
DOI: 10.1016/j.vaccine.2012.06.009
关键词
Vaccine; Influenza; Pandemic; Adjuvant; Recombinant; Antigen; Advax (TM)
资金
- National Institutes of Health, National Institute of Allergy and Infectious Diseases [U01-AI061142, HHSN272200800039 C]
- National Institutes of Health [AI061142, HHSN272200800039C]
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 (TM)). 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 mu g. Serology and safety was followed for 6 months. Results: At baseline, only 9.1% of subjects (95% CI: 6.0-13.2) had seroprotective H1N1/2009 titers. Seroconversion rates varied by rHA dose, presence of adjuvant, subject age and number of immunizations. Eighty percent (95% Cl: 52-96) of 18-49 year olds who received rHA 45 mu g with adjuvant were seroprotected at week 3, representing a 11.1-fold increase in antibody titers from baseline. Advax (TM) adjuvant increased seroprotection rates by 1.9 times after the first, and 2.5 times after the second, immunization when compared to rHA alone. Seroprotection was sustained at 26 weeks and the vaccine was well tolerated with no safety issues. Conclusions: The study confirmed the ability to design, manufacture, and release a recombinant vaccine within a short time from the start of an actual influenza pandemic. Advax (TM) adjuvant significantly enhanced rHA immunogenicity. (C) 2012 Elsevier Ltd. All rights reserved.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据