Status:
COMPLETED
Trial to Evaluate the Safety and Immunogenicity of an Anthrax Recombinant Protective Antigen Vaccine
Lead Sponsor:
VaxGen
Conditions:
Prevention of Anthrax Infection
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
The purpose of this phase 1 study is to evaluate the safety and immunogenicity of rPA102 vaccine, using anthrax vaccine adsorbed (AVA) as a comparator.
Eligibility Criteria
Inclusion
- Able to understand the study and give written informed consent. A signed informed consent must be in place before the initiation of any study interventions.
- Healthy male or female aged 18 to 40 years old (inclusive) without significant physical or clinical laboratory abnormalities.
- Two intact upper arms with sufficient intramuscular (IM) tissue in the deltoid region for vaccine administration.
- For females, negative serum pregnancy test at screening and agreement to use adequate birth control during the first 3 months of the study.
- Willingness and ability to return for all follow-up visits and blood draws for the duration of the study.
- Willingness to complete the Volunteer Diary and to report concomitant medications and adverse events (AEs) to the study site monitors during the study period.
Exclusion
- Prior history of, or known exposure to any form of B. anthracis or any anthrax immunization.
- Member of the Armed Services (Active Duty or Reserve) since 1990, with history of previous anthrax vaccination.
- Employment in an industry involved in contact with ruminant animals, veterinary sciences, or other exposure to B. anthracis.
- Expected to be noncompliant with study visits or planning to move within 8 months.
- Body mass index of \>35 or \<19.
- Known allergy to aluminum hydroxide, formaldehyde, benzethonium chloride, latex, kanamycin, or any other aminoglycoside antibiotics (such as gentamycin).
- Pregnancy (positive urine pregnancy test within 24 hours prior to vaccination), or lactation.
- HIV positive (by history or screening ELISA).
- Hepatitis B or C positive (by history or screening HBsAg/anti-HCV ELISA).
- Active or past internal organ, hematologic malignancy, or metastatic cutaneous malignancy.
- History of, or current autoimmune disease, including but not limited to systemic lupus erythematosus, scleroderma, and polyarteritis.
- Immunodeficiency or unstable medical condition as determined by baseline medical history, physical exam, and laboratory assessment.
- Received, or plans to receive, licensed live vaccines within 30 days of study vaccination.
- Received, or plans to receive, licensed killed vaccines within 14 days of study vaccination.
- Received, or plans to receive, immunoglobulin or other blood products within 60 days of study vaccination.
- Received, or plans to receive, experimental drugs/vaccines within 30 days of study vaccination.
- Received, or plans to receive, systemic immunosuppresive therapy, radiation therapy, or high-dose inhaled steroids within 30 days of study vaccination.
- Use of systemic chemotherapy within 5 years prior to study.
- History of Guillain-Barre Syndrome.
- In addition to the conditions listed above, the following may qualify as a reason to exclude a volunteer from the study: fever along with moderate or serious illness within 3 days of vaccination or any condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the study evaluations. Pending resolution of these symptoms, a volunteer may be reconsidered for vaccination.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00103467
Start Date
June 1 2003
Last Update
June 24 2005
Active Locations (4)
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1
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
2
Dept. of International Health - Johns Hopkins University Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205
3
St. Louis University - SoLutions/SLUtest
St Louis, Missouri, United States, 63104
4
Baylor College of Medicine
Houston, Texas, United States, 77030