1970. Phase 1 Clinical Trial of Intranasal Immunization with M2-Deficient, Single Replication, Live Influenza Vaccine (M2SR): Safety and Immune Response in Adults

ABSTRACT: Abstract

Background

Influenza vaccines are needed with greater effectiveness and breadth of coverage. FluGen is developing M2SR (M2 deficient Single Replication), an investigational, live virus vaccine. M2SR contains the internal proteins of donor A/Puerto Rico/8/34 and hemagglutinin (HA) and neuraminidase (NA) selected from targeted Type A influenza strains. M2SR undergoes only a single round of infection in the respiratory epithelium but evokes an immune response profile similar to wild-type influenza viruses. In influenza naïve and pre-immune ferrets, M2SR protects against multiple influenza A subtypes.

Methods

A Phase 1, first-in-human, randomized, placebo-control study (FluGen-H3N2-V001; ClinicalTrials.gov identifier NCT02822105) was conducted at a single USA site, w

SUBMITTER: Eiden J 

PROVIDER: S-EPMC6254821 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature