Journal
JOURNAL OF INFECTIOUS DISEASES
Volume 206, Issue 6, Pages 811-820Publisher
OXFORD UNIV PRESS INC
DOI: 10.1093/infdis/jis427
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Funding
- Emory University
- Stanford University
- University of Washington
- University of Maryland
- University of Iowa
- Atlanta Clinical and Translational Science Institute
- Public Health Service (PHS) Grant from National Center for Research Resources (NCRR), NIH [UL1 RR025008]
- Clinical and Translational Science Award from the NCRR, NIH [5UL1 RR025744]
- University of Washington Institute of Translational Health Science
- NCRR [7 UL1 RR025014, KL2 RR025015, TL1 RR025016, K12-RR-023250]
- PHS contract from NIAID, NIH [NO1-AI-80001]
- University of Maryland General Clinical Research Center from the NCRR [M01-RR-016500]
- Clinical and Translational Science Award [5UL1 RR025744]
- GSK
- Sanofi Pasteur
- Novartis Vaccines
- Vaccine and Treatment Evaluation Unit contracts from the National Institutes of Health [HHSN272200800004C [Group Health], HHSN27220080000C [Vanderbilt], HHSN272200800001C [Maryland], HHSN272200800005C [Emory], HHSN272200800008C [Iowa], HHSN272200800006C [Cincinnati]]
- [N01-AI-30063]
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Background. Adjuvanted vaccines have the potential to improve influenza pandemic response. AS03 adjuvant has been shown to enhance the immune response to inactivated influenza vaccines. Methods. This trial was designed to evaluate the immunogenicity and safety of an inactivated 2009 H1N1 influenza vaccine at varying dosages of hemagglutinin with and without extemporaneously mixed AS03 adjuvant system in adults >= 18 years of age. Adults were randomized to receive 2 doses of 1 of 5 vaccine formulations (3.75 mu g, 7.5 mu g, or 15 mu g with AS03 or 7.5 mu g or 15 mu g without adjuvant). Results. The study population included 544 persons < 65 years of age and 245 persons >= 65 years of age. Local adverse events tended to be more frequent in the adjuvanted vaccine groups, but severe reactions were uncommon. In both age groups, hemagglutination inhibition antibody geometric mean titers after dose one were higher in the adjuvanted groups, compared with the 15 mu g unadjuvanted group, and this difference was statistically significant for the comparison of the 15 mu g adjuvanted group with the 15 mu g unadjuvanted group. Conclusions. AS03 adjuvant system improves the immune response to inactivated 2009 H1N1 influenza vaccine in both younger and older adults and is generally well tolerated. ClinicalTrials.gov NCT00963157.
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