Trial of rPA-102 Vaccine in Healthy Adult Volunteers
- Conditions
- Anthrax
- Registration Number
- NCT00100724
- Lead Sponsor
- VaxGen
- Brief Summary
The purpose of this study is to assess the safety and immunogenicity of rPA102 vaccine given intramuscularly at 0 and 4 weeks over 2 dose ranges and 4 adjuvant levels.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 480
- 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 18-55 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 2 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.
- 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, or emergency first responders.
- Expected to be noncompliant with study visits or planning to move within 12 months.
- Body mass index of >35 or <19.
- Known allergy to aluminum hydroxide, kanamycin, or any other aminoglycoside antibiotics (such as gentamicin).
- 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 prior to, and for the duration of the study.
- Received or plans to receive systemic immunosuppressive therapy, radiation therapy, or high-dose inhaled steroids within 30 days of study vaccination.
- Use of systemic chemotheraphy 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety and immune response to vaccine.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Pediatric Clinical Trials Int'l, Inc. (PCTI)
🇺🇸Columbus, Ohio, United States
St. Louis University, SoLUtions
🇺🇸St. Louis, Missouri, United States
Primary Physicians Research, Inc.
🇺🇸Pittsburgh, Pennsylvania, United States
Infectious Disease Unit, University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Emory Children's Clinic, Pediatric Infectious Disease
🇺🇸Atlanta, Georgia, United States
Mayo Clinic College of Medicine
🇺🇸Rochester, Minnesota, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Vermont College of Medicine, Vermont Vaccine Evaluation Center
🇺🇸Burlington, Vermont, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
University of Kentucky, Markey Cancer Center
🇺🇸Lexington, Kentucky, United States
UCLA Ctr for Vaccine Research, LA Biomedical Research Institute
🇺🇸Torrance, California, United States
Johns Hopkins University, Bloomberg School of Public Health
🇺🇸Baltimore, Maryland, United States