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VELOCITY: An Anthrax Vaccine Clinical Study
Sponsor: Emergent BioSolutions
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
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.
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