H7N9 Mix and Match With MF59 in Healthy Adults

Summary

This is a Phase II randomized, double-blinded, controlled study in up to 700 males and non-pregnant females, 19 to 64 years old, inclusive, designed to assess the safety, reactogenicity, and immunogenicity of a monovalent influenza A/H7N9 virus vaccine administered at different dosages (3.75, 7.5, or 15 mcg of HA/0.5 mL dose) given with and without MF59 adjuvant and without adjuvant (15 mcg of HA/0.5 mL dose and 45 mcg of HA/0.75 mL dose). Subjects will receive two doses via intramuscular injection, approximately 21 days apart. Safety, reactogenicity, and immunogenicity data will be collected at standard time points with safety follow-up to continue through one year post dose 2. The duration of the study for each subject will be approximately 13 months.

Timeline

Start

2013-09

Primary completion

2014-11

Completion

2014-11

Publications

• Results Mulligan MJ, Bernstein DI, Winokur P, Rupp R, Anderson E, Rouphael N, Dickey M, Stapleton JT, Edupuganti S, Spearman P, Ince D, Noah DL, Hill H, Bellamy AR; DMID 13-0032 H7N9 Vaccine Study Group. Serological responses to an avian influenza A/H7N9 vaccine mixed at the point-of-use with MF59 adjuvant: a randomized clinical trial. JAMA. 2014 Oct 8;312(14):1409-19. doi: 10.1001/jama.2014.12854.
• Lai L, Rouphael N, Xu Y, Kabbani S, Beck A, Sherman A, Anderson EJ, Bellamy A, Weiss J, Cross K, Mulligan MJ. An Oil-in-Water adjuvant significantly increased influenza A/H7N9 split virus Vaccine-Induced circulating follicular helper T (cTFH) cells and antibody responses. Vaccine. 2022 Nov 22;40(49):7065-7072. doi: 10.1016/j.vaccine.2022.09.041. Epub 2022 Oct 21.

Drugs

Indications