33. Intranasal M2SR (M2-deficient Single Replication) Live H3N2 Influenza Investigational Vaccine Induces Serum HAI & Broad Immune Responses in High Proportion of Adults

ABSTRACT: Abstract

Background

A single intranasal (IN) dose of 108 TCID50 M2SR protected a responder subset of adults against infection and disease in a prior human influenza challenge study (EudraCT number: 2017-004971-30). Higher dose levels of M2SR were assessed in this phase 1b study to enhance immune responses and further increase protection levels in adults.

Methods

A double-blind, randomized, placebo-controlled dose escalation study (NCT03999554) was conducted at 4 US study sites with two different H3N2 M2SR vaccines that contained HA & NA from either A/Brisbane/10/2007 or A/Singapore/INFIMH-16–0019/2016. Serosusceptible 18–49 year old subjects (n = 206) received 2 IN doses of either saline or 1 of 3 different dose levels of vaccine (108 – 109 TCID50), administered 28 days a

SUBMITTER: Eiden J 

PROVIDER: S-EPMC7776045 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature