A randomized, controlled non-inferiority trial comparing A(H1N1)pmd09 vaccine antigen, with and without AS03 adjuvant system, co-administered or sequentially administered with an inactivated trivalent seasonal influenza vaccine

BMC Infectious Diseases

Research Article

Laurence Chu¹  Shelly McNeil²  Joanne M Langley²  Scott Halperin²  David Vaughn³  Ping Li³  Louise Frenette⁴ 

[1] Benchmark Research, Austin, TX, USA;Canadian Center for Vaccinology, IWK Health Centre, Capital District Health Authority and Dalhousie University, 5850 University Avenue, B3K 6R8, Halifax, NS, Canada;GlaxoSmithKline Vaccines, King of Prussia, Philadelphia, PA, USA;Q&T Research Inc, Sherbrooke, QC, Canada;

关键词: Adjuvant;    AS03;    Co-administration;    H1N1;    Influenza;    Pandemic;    TIV;   

DOI  :  10.1186/1471-2334-12-279

 received in 2011-12-16, accepted in 2012-10-11,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundAt the time of the influenza A(H1N1)pmd09 pandemic it was not known if concurrent or sequential administration of seasonal trivalent influenza vaccine (TIV) with pandemic vaccine was preferred.MethodsImmunogenicity and safety were assessed in 871 healthy subjects aged 19–40 years who were randomised into six groups to receive co-administration or sequential administration of TIV and two doses of A(H1N1)pmd09 vaccine (either unadjuvanted or adjuvanted with AS03, an α-tocopherol and squalene-based oil-in-water emulsion).ResultsSafety and immunogenicity data (by haemagglutination inhibition [HI] assay) after each dose and six months post-Dose 1 are reported here. Co-administration of A(H1N1)pmd09 vaccine with TIV reduced the HI immune responses to A(H1N1)pmd09 vaccine. However, serologic responses with both co-administration and sequential schedules met the European and US regulatory criteria for pandemic and seasonal influenza vaccines up to six months following the first vaccine dose. The AS03-adjuvanted formulation elicited higher immune responses at all time points. Prior administration or co-administration of A(H1N1)pmd09 vaccine did not affect immune responses to TIV.ConclusionsCo-administration of TIV and A(H1N1)pmd09 vaccine negatively influenced A(H1N1)pmd09 vaccine immunogenicity but had no effect on TIV responses. The non-adjuvanted and adjuvanted vaccines demonstrated strong immune responses against all vaccine strains for up to six months following the first vaccine dose.Trial registrationNCT00985673

【 授权许可】

CC BY   
© Langley et al.; licensee BioMed Central Ltd. 2012