Safety and Efficacy of CR6261 in an Influenza A H1N1 Healthy Human Challenge Model.

ABSTRACT:

Background

It is imperative to identify new targets for improved vaccines and therapeutics against influenza. One such target is the relatively conserved stalk region of the influenza A hemagglutinin (HA) surface protein.

Methods

We conducted a randomized, double-blind, phase 2, placebo-controlled trial of a monoclonal antibody that targets the HA stalk (CR6261) in a H1N1pdm09 healthy volunteer human challenge model. A single 50 mg/kg dose of CR6261 was infused 24 hours after challenge. The primary efficacy outcome was area under the curve (AUC) of viral RNA detection over time.

Results

Ninety-one healthy volunteers were randomized and underwent influenza challenge; 49 received CR6261 and 42 received placebo. CR6261 had no statistically significant effect on AUC (AUC,

SUBMITTER: Han A 

PROVIDER: S-EPMC8664469 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature