714. Long-Term Safety and Immunogenicity of AS03-adjuvanted or Non-adjuvanted H1N1 Vaccines in Adults and the Elderly
Session: Poster Abstract Session: Vaccine Studies, Adjuvants, and Discovery
Friday, October 21, 2011
Room: Poster Hall B1
Background: To assess the safety of AS03 (tocopherol based oil-in-water emulsion Adjuvant System)-adjuvanted or non-adjuvanted A/California/7/2009 vaccines, and to determine whether immunogenicity responses met Center for Biologics Evaluation and Research (CBER) criteria for influenza vaccines up to 182 days after vaccination.

Methods: In this Phase II/III, observer-blind, randomized controlled trial, subjects aged 18–64 years or >64 years received a single dose of either AS03-adjuvanted vaccine containing 3.75 μg A/California/7/2009 hemagglutinin antigen (HA), or non-adjuvanted vaccine containing 15 μg HA. Hemagglutination inhibition at Days 0 (D0), 21 (D21), 42 (D42; in a subset of subjects) and 182 (D182) post-dose 1 was assessed according to CBER criteria: lower limit of 95% confidence interval (CI) for seroconversion rate (SCR) ≥40% (≥30% for elderly) and seroprotection rate (SPR) ≥70% (≥60% for elderly). Solicited and unsolicited adverse events (AEs) were collected for 7 and 21 days, respectively, and potential immune-mediated diseases (pIMD) and serious AEs throughout the study.

Results: A total of 4048 subjects were vaccinated. Both vaccines met or exceeded CBER criteria in both age groups at D21. At D42, criteria were met for both age strata for the adjuvanted vaccine but in younger adults (≤64 years) only for the non-adjuvanted vaccine. At D182, criteria were met in younger adults only for both vaccines. D182 SCRs, SPRs and geometric mean titers (GMT) are shown in the table. Injection site solicited pain was reported more frequently in the adjuvanted (82.1% and 56.7% in adults and elderly) vs non-adjuvanted groups (29.9% and 9.4%, respectively). No serious AEs related to vaccination were reported. Of 8 pIMDs reported (4 in each vaccine group), one was considered related to vaccination (adjuvanted vaccine group).

Day 182

18–64 years

>64 years

 

Adjuvanted

Non-adjuvanted

Adjuvanted

Non-adjuvanted

SCR, %

62.3

53.7

34.9

26.6

SPR, %

82.1

75.3

51.4

43.1

GMT

109.5

83.3

37.1

29.2

Conclusion: AS03-adjuvanted H1N1 vaccine with a low HA (3.75 µg) antigen content was shown to be highly immunogenic in young adults and the elderly, and has induced antibody persistence for six months in young adults. Both vaccines had a clinically acceptable safety profile.


Subject Category: I. Adult and Pediatric Vaccines

William Yang1, Marc Dionne2, Olivier Godeaux3, Miguel Madariaga3, Ping Li, MS3 and David Vaughn3, (1)Allergy & Asthma Research Center, Ottawa, ON, Canada, (2)Institut national de sante publique du Quebec, Quebec City, QC, Canada, (3)GlaxoSmithKline Biologicals, King of Prussia, PA

Disclosures:

W. Yang, GlaxoSmithKline: Investigator and National advisory board member, Educational grant and Research grant

M. Dionne, GlaxoSmithKline: Investigator and Scientific Advisor, Consulting fee, Research grant and Research support

O. Godeaux, GlaxoSmithKline: Shareholder, Stock

M. Madariaga, GlaxoSmithKline: Employee, Salary

P. Li, GlaxoSmithKline: Employee, Salary

D. Vaughn, GlaxoSmithKline: Employee, GSK stock and Salary

Findings in the abstracts are embargoed until 12:01 a.m. EST Thursday, Oct. 20 with the exception of research findings presented at IDSA press conferences.