NCT02655549

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

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 Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Pfenex, Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Anthrax

Interventions

Type	Name	Description
BIOLOGICAL	Px563L, RPA563, or placebo	Two intramuscular injections

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2016-01-14
• Last updated: 2017-07-11

Locations

1 site across 1 country: United States