Long-term immunogenicity of an AS03-adjuvanted influenza A(H1N1)pdm09 vaccine in young and elderly adults: An observer-blind, randomized trial

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• 作者：William H. Yang ; Marc Dionne ; Michael Kyle ; Naresh Aggarwal ; Ping Li ; Miguel Madariaga ; Olivier Godeaux ; David W. Vaughn
• 关键词：ATP ; according to protocol ; BARDA ; Biomedical Advanced Research and Development Authority ; BMI ; body mass index ; CBER ; Center for Biologics Evaluation & Research ; CHMP ; Committee for Medicinal Products for Human Use ; CI ; confidence interval ; GMFR ; geometr
• 刊名：Vaccine
• 出版年：2013
• 出版时间：13 September, 2013
• 年：2013
• 卷：31
• 期：40
• 页码：4389-4397
• 全文大小：1732 K

文摘

Background

This study () evaluated the immunogenicity and relative protective efficacy of one dose of influenza A(H1N1)pdm09 vaccine with or without AS03 (an ¦Á-tocopherol oil-in-water emulsion based Adjuvant System).

Methods

Four thousands and forty-eight healthy adults aged ¡Ý18 years were randomized (1:1) to receive one dose of either the adjuvanted split virion (3.75 ¦Ìg hemagglutinin antigen [HA]/AS03) or non-adjuvanted (15 ¦Ìg HA) vaccine. Hemagglutination inhibition [HI] antibody response was evaluated before vaccination and at Days 21, 42 and 182 (Month 6). Safety of the study vaccines was evaluated during the entire study duration.

Results

At Day 21, both study vaccines induced HI immune responses meeting the US regulatory criteria in subjects 18-64 years (seroprotection rate [SPR]: 98.0 % [97.1-98.6]; seroconversion rate [SCR]: 89.7 % [88.0-91.2] in the AS03-adjuvanted group; SPR: 91.4 % [89.9-92.8]; SCR: 74.6 % [72.3-76.9] in the non-adjuvanted group) and >64 years of age (SPR: 86.0 % [82.5-89.0]; SCR: 75.3 % [71.1-79.2] in the AS03-adjuvanted group; SPR: 69.1 % [64.6-73.3]; SCR: 56.7 % [52.0-61.3] in the non-adjuvanted group). The AS03-adjuvanted vaccine induced higher HI geometric mean titers than the non-adjuvanted vaccine at all time points. At Month 6, only subjects 18-64 years of age from both vaccine groups still met the US regulatory criteria (SPR: 82.1 % [80.0-84.1]; SCR: 62.3 % [59.6-64.8] in the AS03-adjuvanted group; SPR: 75.3 % [72.9-77.5]; SCR: 53.7 % [51.0-56.4] in the non-adjuvanted group). Protective efficacy was not evaluated due to low number of RT-qPCR-confirmed A(H1N1)pdm09 influenza cases. Through Month 12, 216 serious adverse events (in 157 subjects: 84 in the AS03-adjuvanted and 73 in the non-adjuvanted group) and 12 potentially immune mediated diseases (5 in the AS03-adjuvanted and 7 in the non-adjuvanted group) were reported.

Conclusion

A single dose of either adjuvanted or non-adjuvanted influenza A(H1N1)pdm09 vaccine induced protective HI antibody levels against the A/California/7/2009 strain that persisted through Month 6 in the 18-64 years population.