H5N8 Mix and Match With or Without AS03 or MF59 in Healthy Adults: Immunology
Status:
Completed
Trial end date:
2018-12-19
Target enrollment:
Participant gender:
Summary
This is a Phase I cohort-randomized, double-blind, controlled trial designed to assess the
safety, reactogenicity, and immunogenicity of a monovalent inactivated influenza A/H5N8 virus
vaccine administered at different dosages (3.75 and 15 mcg of HA per dose) given with or
without AS03 or MF59 adjuvants. This study will be conducted at 6 sites and enroll 150 (up to
380) males and non-pregnant females, 19 to 64 years old, inclusive who are in good health and
meet all eligibility criteria. The entire study duration is approximately 24 months and each
subject participation duration is approximately 13 months. The primary objectives are: 1) To
assess the safety and reactogenicity of a monovalent inactivated influenza A/H5N8 virus
vaccine following receipt of two doses administered intramuscularly at different dosages
(3.75 and 15 mcg of HA per dose) given with or without AS03 or MF59 adjuvants approximately
21 days apart. 2) To assess the serum HAI and Neut antibody responses to a monovalent
inactivated influenza A/H5N8 virus vaccine following receipt of two doses administered
intramuscularly at different dosages (3.75 and 15 mcg of HA per dose) given with or without
AS03 or MF59 adjuvants approximately 21 days apart.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)