Safety and Immunogenicity of Cam2020 M2SR H3N2 Monovalent Influenza Vaccine Alone or With Licensed IIV in Older Adults

Phase 1 Completed 303 enrolled FluGen Inc United States Department of Defense · collab

RandomizedParallel-groupQuadruple-blindBasic science

Summary

This is a randomized, double-blind, double-dummy, placebo-controlled Phase 1b study evaluating the safety and immunogenicity of the investigational Cam2020 M2SR H3N2 influenza vaccine delivered IN alone or concomitantly with inactivated influenza vaccine (IIV) delivered IM to a healthy adult population age 65 to 85 years at time of enrollment.

Timeline

Start: 2022-06-14
Primary completion: 2022-11-03
Completion: 2022-11-03

Publications

Eiden J, Fierro C, White A, Davis M, Rhee M, Turner M, Murray B, Herber R, Aitchison R, Marshall D, Moser MJ, Belshe R, Greenberg H, Coelingh K, Kawaoka Y, Neumann G, Bilsel P. Safety and immunogenicity of the intranasal H3N2 M2-deficient single-replication influenza vaccine alone or coadministered with an inactivated influenza vaccine (Fluzone High-Dose Quadrivalent) in adults aged 65-85 years in the USA: a multicentre, randomised, double-blind, double-dummy, phase 1b trial. Lancet Infect Dis. 2024 Oct;24(10):1118-1129. doi: 10.1016/S1473-3099(24)00351-7. Epub 2024 Jul 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cam2020 M2SR	Vaccine	—	Intranasal
Subject	Influenza Virus Vaccine	Vaccine	—	Intramuscular

Indications

No indication recorded.