H7N9 Vaccination With and Without AS03 and Unadjuvanted H3N2v Vaccination: Standard and Systems Biology Analyses
Status:
Completed
Trial end date:
2018-02-14
Target enrollment:
Participant gender:
Summary
This is a single center, randomized, partially-blinded, Phase II, small, targeted,
prospective study in approximately 30 healthy male and non-pregnant female subjects aged 18
to 49 years old, inclusive, designed to evaluate and compare the immunogenicity between an
intramuscular monovalent inactivated influenza A/H7N9 virus vaccine given with and without
AS03 adjuvant, and an intramuscular unadjuvanted monovalent inactivated influenza A/H3N2v
virus vaccine. The primary objectives are (1) assessing the serum anti-HA
hemagglutination-inhibition (HAI) response to influenza A/H7N9 antigen (with and without
adjuvant) at Day 57 (approximately one month after the second study vaccination with A/H7N9
vaccine with or without AS03) and influenza A/H3N2v antigen at Day 29 (approximately one
month after the study vaccination with A/H3N2v), and (2) identifying differentially expressed
genes in human immune cells on Days 2, 4, and 29 (following the first study vaccination with
A/H7N9 vaccine with or without AS03) and on Days 30, 32, and 36 (following the second study
vaccination with A/H7N9 vaccine with or without AS03), compared to baseline assessments
performed prior to each study vaccination (Days -7, 1, and 29).
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)