NCT01770743

A Phase 2 Safety and Immunogenicity Study for an Anthrax Vaccine Using 3 Schedules and Two Dose Levels

A Phase 2, Randomized, Parallel-Group, Active-Controlled, Double-Blind Study to Evaluate the Safety and Immunogenicity of AV7909 for Post-Exposure Prophylaxis of Anthrax Using Three Immunization Schedules and Two Dose Levels in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Emergent BioSolutions · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety and immunogenicity of an anthrax vaccine. The vaccine schedule and dose will also be assessed.

Detailed description

The safety and immunogenicity of AV7909 for post-exposure prophylaxis of anthrax will be evaluated using a randomized, parallel-group, active-controlled, double-blind design with three immunization schedules and two dose levels in healthy adult volunteers. Safety will be assessed by clinical laboratory tests (hematology, serum chemistry, and urinalysis), monitoring of adverse events, vital signs, and physical examinations. Reactogenicity (systemic and injection site reactions) will be assessed by the subjects using subject e-diaries for 7 days after each immunization and by the investigator at in-clinic visits 7 and 14 days after each immunization, and at other visits, if applicable. Immunogenicity will be measured as toxin neutralizing antibody (TNA) response and seroconversion rates.

Conditions

• Anthrax

Interventions

Type	Name	Description
BIOLOGICAL	AV7909	Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant
BIOLOGICAL	BioThrax

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-02-01
• Completion: 2014-12-01
• First posted: 2013-01-18
• Last updated: 2024-03-18
• Results posted: 2015-02-24

Locations

4 sites across 1 country: United States