Status:
COMPLETED
Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults
Lead Sponsor:
Emergent BioSolutions
Collaborating Sponsors:
Department of Health and Human Services
Conditions:
Anthrax
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this Phase 3 clinical trial is to evaluate the immunogenicity and safety of BioThrax anthrax vaccine in healthy adults following 3 doses of BioThrax. Results of this study will be used ...
Detailed Description
BioThrax® (also called Anthrax Vaccine Adsorbed or AVA) is the only FDA-licensed vaccine for the prevention of anthrax infection. This study will evaluate the immunogenicity of the vaccine using a pos...
Eligibility Criteria
Inclusion
- Be between 18 and 65 years of age, inclusive, at the time of enrollment.
- Be in good health as determined by the investigator from medical history and a physical examination.
- If a pre-menopausal female, must be using acceptable methods of birth control.
- Have all hematology and chemistry parameters (measured at Screening) within the laboratory's normal range.
- Be willing and able to return for all visits and blood collections for the duration of the study.
- Have read, understood and signed an informed consent form.
Exclusion
- Prior immunization with anthrax vaccine or known exposure to anthrax organisms.
- Intend to enlist in the military during the study.
- Have a known allergy to aluminum hydroxide, formaldehyde, benzethonium chloride, or latex.
- Plan to receive experimental products at any time during the study.
- Have received a live vaccine in the 30 days before study entry.
- Plan to receive a live vaccine at any time during the study.
- Have ongoing drug abuse/dependence (including alcohol) issues and/or test positive in a urine drug screen for amphetamines, barbiturates, cocaine or opiates;
- Have received immunosuppressive therapy (including systemic steroids) within 3 months prior to study entry.
- Have a condition known to produce or be associated with immunosuppression.
- Have received cytotoxic therapy in the previous 5 years.
- A medical condition that, in the opinion of the Principal Investigator (PI), could adversely impact the subject's participation, safety, or conduct of the study.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01491607
Start Date
November 1 2011
End Date
May 1 2012
Last Update
April 9 2024
Active Locations (4)
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1
Miami Research Associates
Miami, Florida, United States, 33143
2
Rochester Clinical Research
Rochester, New York, United States, 14609
3
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States, 29464
4
Jean Brown Research
Salt Lake City, Utah, United States, 84124