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

PHASE1CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

October 31, 2014

Study Completion Date

September 30, 2015

Conditions
Anthrax Infection
Interventions
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"

Trial Locations (4)

20910

Walter Reed Army Institute for Research, Silver Spring

29464

Coastal Carolina Research Center, Mt. Pleasant

63104

St. Louis University, St Louis

64114

The Center for Pharmaceutical Research, Kansas City

Sponsors
All Listed Sponsors
lead

Emergent BioSolutions

INDUSTRY