A Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Older Adults

Phase 3 Completed 398 enrolled Bavarian Nordic Emergent BioSolutions · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

Demonstrate that the vaccine offers protection based on antibody levels in older adults and is similar to antibody levels in adults aged 18-45 following vaccination with PXVX0200.

Timeline

Start: 2014-05
Primary completion: 2015-02
Completion: 2015-06

Outcome

Met primary endpoint

paper Day 11 seroconversion occurred in 90.4% of older adults vs 93.5%% of younger adults and met the endpoint of demonstrating non-inferiority between the two groups. PMID 30772070 ↗

release “a Phase 3 study that demonstrated a similar immune response in older adults compared with younger adults” emergentbiosolutions.com ↗

Publications

Results McCarty JM, Lock MD, Bennett S, Hunt KM, Simon JK, Gurwith M. Age-related immunogenicity and reactogenicity of live oral cholera vaccine CVD 103-HgR in a randomized, controlled clinical trial. Vaccine. 2019 Mar 7;37(11):1389-1397. doi: 10.1016/j.vaccine.2019.01.077. Epub 2019 Feb 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PXVX0200	Vaccine	1e+09 unknown	Oral