Trial of rPA-102 Vaccine in Healthy Adult Volunteers

Completed · Phase 2

Conditions studied: Anthrax

In brief

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.

Key facts

Study ID

NCT00100724

Run by

VaxGen

People needed

480

Starts

2004-04-01

Expected to finish

2005-07-01

Last updated by the study team

2006-01-12

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UCLA Ctr for Vaccine Research, LA Biomedical Research Institute — Torrance, California, United States
• Emory Children's Clinic, Pediatric Infectious Disease — Atlanta, Georgia, United States
• University of Kentucky, Markey Cancer Center — Lexington, Kentucky, United States
• Johns Hopkins University, Bloomberg School of Public Health — Baltimore, Maryland, United States
• Mayo Clinic College of Medicine — Rochester, Minnesota, United States
• St. Louis University, SoLUtions — St Louis, Missouri, United States
• Infectious Disease Unit, University of Rochester Medical Center — Rochester, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Pediatric Clinical Trials Int'l, Inc. (PCTI) — Columbus, Ohio, United States
• Primary Physicians Research, Inc. — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Vermont College of Medicine, Vermont Vaccine Evaluation Center — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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