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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase 1a Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Study Assessing Safety and Immunogenicity of Px563L and RPA563 Administered by Intramuscular Injection in Healthy Adult Volunte

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

Detailed Summary: This is a Phase 1, double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of Px563L or RPA563 administered intramuscularly. All subjects will be followed for safety and tolerability for 393 days after the initial vaccination. Immunogenicity analyses will be performed for up to 182 days, including an interim analysis based on Day 70 results, after the initial vaccination.
Sponsor: Pfenex, Inc

Current Primary Outcome: Adverse events (AE) and adverse events of special interest (AESI) for vaccines [ Time Frame: 393 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Anthrax toxin neutralizing antibody (TNA) 50% neutralization factor (NF50) value [ Time Frame: 182 days ]

Original Secondary Outcome: Same as current

Information By: Pfenex, Inc

Dates:
Date Received: January 12, 2016
Date Started: December 2015
Date Completion: June 2017
Last Updated: May 3, 2016
Last Verified: May 2016