Trial of rPA-102 Vaccine in Healthy Adult Volunteers

NCT ID: NCT00100724

Last Updated: 2006-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2005-07-31

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.

Conditions

Anthrax

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

rPA102

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

VaxGen

INDUSTRY

Sponsor Role: lead

Locations

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

Countries

United States

Other Identifiers

VAX006

Identifier Type: -

Identifier Source: org_study_id