Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults

Phase 1 Completed 105 enrolled Emergent BioSolutions Department of Health and Human Services · collab National Institute of Allergy and Infectious Diseases (NIAID) · collab

RandomizedParallel-groupTriple-blindPrevention

Summary

The purpose of this Phase 1 clinical trial is to evaluate the safety, tolerability, and immunogenicity of AV7909 anthrax vaccine in healthy adults. In this study, healthy male and female subjects between 18 and 50 years of age will receive vaccinations via the intramuscular (IM) route at Days 0 and 14. Safety and tolerability will be evaluated via laboratory tests, physical examinations, vital signs, adverse events (AEs), concomitant medications, and local and systemic signs and symptoms of reactogenicity.

Timeline

Start: 2010-12
Primary completion: 2012-05
Completion: 2012-06

Publications

Results Hopkins RJ, Daczkowski NF, Kaptur PE, Muse D, Sheldon E, LaForce C, Sari S, Rudge TL, Bernton E. Randomized, double-blind, placebo-controlled, safety and immunogenicity study of 4 formulations of Anthrax Vaccine Adsorbed plus CPG 7909 (AV7909) in healthy adult volunteers. Vaccine. 2013 Jun 26;31(30):3051-8. doi: 10.1016/j.vaccine.2013.04.063. Epub 2013 May 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	BioThrax	Vaccine	0.25 ml	Intramuscular
Comparator	BioThrax	Vaccine	0.5 ml	Intramuscular
Subject	agatolimod	Oligonucleotide (other)	0.25 mg	Intramuscular
Subject	agatolimod	Oligonucleotide (other)	0.5 mg	Intramuscular

Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults

Summary

Timeline

Publications

Drugs

Indications