drugset / Trial / NCT01979406

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

NCT01979406 ↗

Phase 1 Completed 120 enrolled Emergent BioSolutions
RandomizedFactorialQuadruple-blindPrevention

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.

Timeline

Start
2013-11
Primary completion
2014-10
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Ad4-PA-1 Unknown 1e+09 vg Oral
Subject Ad4-PA-1 Unknown 1e+10 vg Oral
Subject Ad4-PA-1 Unknown 1e+11 vg Oral
Subject Ad4-PA-GPI-1 Unknown 1e+09 vg Oral
Subject Ad4-PA-GPI-1 Unknown 1e+10 vg Oral
Subject Ad4-PA-GPI-1 Unknown 1e+11 vg Oral
Subject Anthrax vaccine adsorbed (BioThrax) Unknown 0.5 ml Intramuscular

Indications