A Study of Anthrax Vaccines Px563L and RPA563 in Healthy Adult Subjects

NCT02655549 ↗

Phase 1 Completed 54 enrolled Pfenex, Inc Department of Health and Human Services · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The trial investigates Px563L and RPA563, two formulations of a novel anthrax vaccine.

Timeline

Start: 2015-12
Primary completion: 2017-06
Completion: 2017-06

Outcome

Met primary endpoint

paper For the primary immunogenicity endpoint (protective toxin neutralizing antibody 50% neutralization factor [TNA NF50]), titers started to increase significantly PMID 34544599 ↗

paper with the geometric mean and lower bound of the 95% confidence interval exceeding 0.56 PMID 34544599 ↗

Publications

Schneider JC, Chen HC, Bautista E, Retallack D. Safety and immunogenicity of Px563L, a recombinant anthrax vaccine candidate, in a two-dose regimen for post-exposure prophylaxis in healthy adults. Vaccine. 2021 Oct 8;39(42):6333-6339. doi: 10.1016/j.vaccine.2021.08.075. Epub 2021 Sep 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Px563L	Vaccine	10 ug	Intramuscular
Subject	Px563L	Vaccine	50 ug	Intramuscular
Subject	RPA563	Vaccine	—	Intramuscular