Status:
COMPLETED
Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults
Lead Sponsor:
Emergent BioSolutions
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Department of Health and Human Services
Conditions:
Bacillus Anthracis (Anthrax) Infection
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this Phase 1 clinical trial is to evaluate the safety, tolerability, and immunogenicity of AV7909 anthrax vaccine in healthy adults. In this study, healthy male and female subjects betw...
Detailed Description
AV7909 is a new vaccine which is a combination of BioThrax (also called anthrax vaccine, adsorbed or AVA), a FDA-licensed vaccine, and CPG 7909. CPG 7909 is a synthetic short DNA sequence that has bee...
Eligibility Criteria
Inclusion
- Be between 18 and 50 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.
- Have negative values for the following tests at Screening: Hepatitis C antibody, anti-Human Immunodeficiency Virus (Anti-HIV-1/-2/-O), and anti-Hepatitis B Core Antigen (Anti-HBc).
- Be willing and capable of complying with all aspects of the protocol through completion of the required visits.
- Have not donated blood in the preceding 8 weeks and are willing to not donate blood or plasma within 56 days after dosing.
- Have adequate venous access for repeat phlebotomies.
- Have read, understood and signed an informed consent form.
Exclusion
- Key
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT01263691
Start Date
December 1 2010
End Date
June 1 2012
Last Update
March 18 2024
Active Locations (3)
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1
Miami Research Associates
Miami, Florida, United States, 33143
2
North Carolina Clinical Research
Raleigh, North Carolina, United States, 27607
3
Jean Brown Research
Salt Lake City, Utah, United States, 84124