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COMPLETED
NCT03877926
PHASE3

VELOCITY: An Anthrax Vaccine Clinical Study

Sponsor: Emergent BioSolutions

View on ClinicalTrials.gov

Summary

This study is designed to evaluate the lot consistency (using three consecutively manufactured lots), safety, and ability of the AV7909 anthrax vaccine to generate an immune response in healthy adults and compare the response to that induced by the currently licensed vaccine, BioThrax®, (Anthrax Vaccine Adsorbed; AVA) for post-exposure of anthrax disease.

Official title: A Phase 3, Randomized, Double-blind, Parallel-group Trial to Evaluate the Lot Consistency, Immunogenicity, and Safety of AV7909 for Postexposure Prophylaxis of Anthrax in Healthy Adults

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

3689

Start Date

2019-03-11

Completion Date

2020-08-06

Last Updated

2026-05-06

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

AV7909

AV7909 consists of Anthrax Vaccine Adsorbed (AVA) drug substance and CPG 7909 adjuvant. AVA drug substance in AV7909 is similar in composition and manufactured using the same process as commercial BioThrax® vaccine. BioThrax is licensed for post-exposure prophylaxis of anthrax disease. CPG 7909 is an immunostimulatory synthetic oligodeoxynucleotide that functions as an adjuvant. It is designed to induce an enhanced immune response.

BIOLOGICAL

BioThrax

BioThrax vaccine (Anthrax Vaccine Adsorbed; AVA) is licensed for post-exposure prophylaxis of anthrax disease.

Locations (35)

Achieve Clinical Research, LLC

Birmingham, Alabama, United States

Optimal Research, LLC

Huntsville, Alabama, United States

Coastal Clinical Research, an AMR company

Mobile, Alabama, United States

Central Phoenix Medical Clinic, LLC

Phoenix, Arizona, United States

Clinical Research Consortium, an AMR company

Tempe, Arizona, United States

California Research Foundation

San Diego, California, United States

Optimal Research, LLC

San Diego, California, United States

Research Centers of America

Hollywood, Florida, United States

Optimal Research, LLC

Melbourne, Florida, United States

New Horizon Research Center, Inc

Miami, Florida, United States

Meridian Clinical Research, LLC

Savannah, Georgia, United States

Advanced Clinical Research

Boise, Idaho, United States

Christie Clinic, LLC

Champaign, Illinois, United States

Optimal Research, LLC

Peoria, Illinois, United States

The Iowa Clinic, PC

West Des Moines, Iowa, United States

Heartland Research Associates, LLC

Augusta, Kansas, United States

Hutchinson Clinic

Hutchinson, Kansas, United States

Johnson County Clin-Trials, LLC

Lenexa, Kansas, United States

Heartland Research Associates, LLC

Wichita, Kansas, United States

Benchmark Research New Orleans

Metairie, Louisiana, United States

Optimal Research, LLC

Rockville, Maryland, United States

The Center for Pharmaceutical Research, an AMR company

Kansas City, Missouri, United States

Meridian Clinical Research, LLC

Omaha, Nebraska, United States

Clinical Research Center of Nevada LLC

Las Vegas, Nevada, United States

Rapid Medical Research, Inc.

Cleveland, Ohio, United States

Aventiv Research Inc.

Grove City, Ohio, United States

Lynn Institute of Norman

Norman, Oklahoma, United States

Coastal Carolina Research Center, Inc

Mt. Pleasant, South Carolina, United States

Spartanburg Medical Research

Spartanburg, South Carolina, United States

Clinical Research Associates, Inc.

Nashville, Tennessee, United States

Tekton Research

Austin, Texas, United States

Benchmark Research

Fort Worth, Texas, United States

Benchmark Research San Angelo

San Angelo, Texas, United States

Martin Diagnostic Clinic

Tomball, Texas, United States

Advanced Clinical Research

West Jordan, Utah, United States