Two Doses of Multimeric-001 (M-001) Followed by Influenza Vaccine

Summary

This is a Phase II randomized, double-blind, placebo-controlled trial in 120 males and non-pregnant females, 18 to 49 years old, inclusive, who are in good health and meet all eligibility criteria. This clinical trial will be conducted at 3 United States sites and is designed to assess the safety, reactogenicity, and immunogenicity of two priming doses of M-001 followed by a seasonal quadrivalent inactivated influenza vaccine (IIV4). The duration of this trial for each subject will be approximately 7 months. The entire study duration will be approximately 24 months. The primary objectives are: 1) To assess the safety as measured by vaccine related adverse events, reactogenicity, and laboratory adverse events of two doses of M-001 vaccine, each dose administered approximately 21 days apart; and 2) To assess the T cell responses to M-001 component peptides following two doses of M-001.

Timeline

Start

2018-04-09

Primary completion

2019-01-14

Completion

2019-01-14

Publications

• Atmar RL, Bernstein DI, Winokur P, Frey SE, Angelo LS, Bryant C, Ben-Yedidia T, Roberts PC, El Sahly HM, Keitel WA. Safety and immunogenicity of Multimeric-001 (M-001) followed by seasonal quadrivalent inactivated influenza vaccine in young adults - A randomized clinical trial. Vaccine. 2023 Apr 17;41(16):2716-2722. doi: 10.1016/j.vaccine.2023.03.023. Epub 2023 Mar 21.

Drugs

Indications