NCT01979406

A Phase 1 Ascending Dose Study to Assess the Safety and Immunogenicity of Adenovirus Anthrax Vector Candidate Vaccines

A Phase 1 Randomized Double-Blind Positive-Controlled Ascending Dose Study to Evaluate the Safety and Immunogenicity of a Replication-Competent Adenovirus Serotype 4 Anthrax Vector Candidate Vaccines - Ad4-PA (Protective Antigen)and Ad4-PA-GPI (Glycosylphosphatidylinositol)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Emergent BioSolutions · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate 2 vaccine candidates against anthrax compared to the positive (vaccine) control as studied in normal healthy volunteers.

Detailed description

A Phase 1, randomized, double-blind, positive controlled, increasing dose clinical trial in healthy adult subjects at multiple sites. The study will assess safety and immunogenicity of two adenovirus vaccine candidates against anthrax compared to the positive control, Anthrax Vaccine Adsorbed (AVA). The trial will enroll 108 subjects in the anthrax vector vaccine arms and 12 subjects in the AVA positive control subjects. The study will look at three different dose of oral dosages of Ad4-PA (protective antigen) and Ad4-PA-GPI (10\^9, 10\^10, 10\^11 vp/dose)as well as 3 vaccine administration schedules (1 and 15 days; 1 and 29 days; 1, 15, and 29 days); 2 of 3 schedules will include an intramuscular (IM) AVA booster immunization, 1 schedule will include 3 vaccine administrations of Ad4-PA or Ad4-PA-GPI (glycosylphosphatidylinositol) alone, and 1 schedule will include 3 vaccine administrations of AVA alone.

Conditions

• Anthrax Infection

Interventions

Type	Name	Description
BIOLOGICAL	AVA	Anthrax Vaccine Adsorbed (0.5 mL) as the placebo control on Days 1, 15 and 29
BIOLOGICAL	Ad4-PA-1	Ad4-PA will be given at 10\^9, 10\^10 and 10\^11 on Day, followed by an oral placebo on Day 15 and an AVA boost on Day 29
BIOLOGICAL	Ad4-PA-GPI-1	Given at 10\^9, 10\^10 and 10\^11 viral particles Ad4 PA-GPI at Day 1 + oral placebo on Day 29 + AVA boost at Day 15

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-10-01
• Completion: 2015-09-01
• First posted: 2013-11-08
• Last updated: 2024-03-18

Locations

4 sites across 1 country: United States