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Responses to A(H1N1)09pdm influenza vaccines in subjects previously vaccinated with seasonal influenza vaccine: A randomized, observer-blind, controlled study
Sumita Roy-Ghanta1,
Robbert Van der Most2,
Ping Li1 and
David W. Vaughn2
+ Author Affiliations
1GlaxoSmithKlineVaccines, King of Prussia, Pennsylvania , US
2GlaxoSmithKline Vaccines, Rixensart, Belgium
Corresponding author: Sumita Roy-Ghanta, sumita.x.roy-ghanta@gsk.com
Abstract
Background. Prior receipt of a trivalent seasonal influenza vaccine (TIV) can affect hemagglutination inhibition (HI) antibody responses to pandemic influenza vaccines. We investigated the effect of TIV-priming on humoral responses to AS03-adjuvanted and non-adjuvanted A(H1N1)pdm09 vaccines, the role of AS03 on cell-mediated immune (CMI) responses, and vaccine safety.
Methods. Healthy adults (19-40 years) were randomized 1:1:1:1 to receive TIV or saline followed 4 months later by two doses, 3 weeks apart, of adjuvanted or non-adjuvanted A(H1N1)pdm09 vaccine and followed up to study end (Day 507). Pre- and post-vaccination responses of HI and neutralizing antibody, CD4+/CD8+ T cells, memory B cells and plasmablasts were assessed.
Results. Ninety-nine of the 133 subjects enrolled completed the study. No vaccine-related serious adverse events were recorded. In TIV-primed subjects, A(H1N1)09pdm-specific antibody, CD4+ T-cell and memory B-cell responses to the pandemic vaccine tended to be diminished. Vaccine adjuvantation led to increased responses of vaccine-homologous and -heterologous HI and neutralizing antibodies and CD4+ T cells, homologous memory B cells and plasmablasts.
Conclusions. In healthy adults, prior TIV administration decreased humoral and CMI responses to A(H1N1)09pdm vaccine. Adjuvantation of A(H1N1)pdm09 antigen helped to overcome immune interference between the influenza vaccines. No safety concerns were observed.
Sumita Roy-Ghanta1,
Robbert Van der Most2,
Ping Li1 and
David W. Vaughn2
+ Author Affiliations
1GlaxoSmithKlineVaccines, King of Prussia, Pennsylvania , US
2GlaxoSmithKline Vaccines, Rixensart, Belgium
Corresponding author: Sumita Roy-Ghanta, sumita.x.roy-ghanta@gsk.com
Abstract
Background. Prior receipt of a trivalent seasonal influenza vaccine (TIV) can affect hemagglutination inhibition (HI) antibody responses to pandemic influenza vaccines. We investigated the effect of TIV-priming on humoral responses to AS03-adjuvanted and non-adjuvanted A(H1N1)pdm09 vaccines, the role of AS03 on cell-mediated immune (CMI) responses, and vaccine safety.
Methods. Healthy adults (19-40 years) were randomized 1:1:1:1 to receive TIV or saline followed 4 months later by two doses, 3 weeks apart, of adjuvanted or non-adjuvanted A(H1N1)pdm09 vaccine and followed up to study end (Day 507). Pre- and post-vaccination responses of HI and neutralizing antibody, CD4+/CD8+ T cells, memory B cells and plasmablasts were assessed.
Results. Ninety-nine of the 133 subjects enrolled completed the study. No vaccine-related serious adverse events were recorded. In TIV-primed subjects, A(H1N1)09pdm-specific antibody, CD4+ T-cell and memory B-cell responses to the pandemic vaccine tended to be diminished. Vaccine adjuvantation led to increased responses of vaccine-homologous and -heterologous HI and neutralizing antibodies and CD4+ T cells, homologous memory B cells and plasmablasts.
Conclusions. In healthy adults, prior TIV administration decreased humoral and CMI responses to A(H1N1)09pdm vaccine. Adjuvantation of A(H1N1)pdm09 antigen helped to overcome immune interference between the influenza vaccines. No safety concerns were observed.
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