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J Infect Dis. 2012 Jul 10. [Epub ahead of print]
Immunogenicity and Safety of Varying Dosages of a Monovalent 2009 H1N1 Influenza Vaccine Given with and without AS03 Adjuvant System in Healthy Adults and Seniors.
Jackson LA, Chen WH, Stapleton JT, Dekker CL, Wald A, Brady RC, Edupuganti S, Winokur P, Mulligan MJ, Keyserling HL, Kotloff KL, Rouphael N, Noah DL, Hill H, Wolff MC.
Source
Group Health Research Institute, Seattle, WA.
Abstract
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. Subjects were randomized to receive two doses of one of five vaccine formulations (3.75 ?g, 7.5 ?g, or 15 ?g with AS03, or 7.5 ?g or 15 ?g without adjuvant).Results. The study population included 544 subjects <65 years of age and 245 subjects ≥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 post dose one were higher in the adjuvanted groups compared with 15 ?g unadjuvanted group, and this difference was statistically significant for the comparison of the 15 ?g adjuvanted group with the 15 ?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.
PMID:
22782949
[PubMed - as supplied by publisher]
Immunogenicity and Safety of Varying Dosages of a Monovalent 2009 H1N1 Influenza Vaccine Given with and without AS03 Adjuvant System in Healthy Adults and Seniors.
Jackson LA, Chen WH, Stapleton JT, Dekker CL, Wald A, Brady RC, Edupuganti S, Winokur P, Mulligan MJ, Keyserling HL, Kotloff KL, Rouphael N, Noah DL, Hill H, Wolff MC.
Source
Group Health Research Institute, Seattle, WA.
Abstract
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. Subjects were randomized to receive two doses of one of five vaccine formulations (3.75 ?g, 7.5 ?g, or 15 ?g with AS03, or 7.5 ?g or 15 ?g without adjuvant).Results. The study population included 544 subjects <65 years of age and 245 subjects ≥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 post dose one were higher in the adjuvanted groups compared with 15 ?g unadjuvanted group, and this difference was statistically significant for the comparison of the 15 ?g adjuvanted group with the 15 ?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.
PMID:
22782949
[PubMed - as supplied by publisher]
