Trial of rPA-102 Vaccine in Healthy Adult Volunteers

Anthrax Clinical Trial

Official title:

A Phase 2 Multi-Center, Randomized Dose-Finding Trial of rPA-102 Vaccine in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00100724
• Other study ID #: VAX006
• Status: Completed
• Phase: Phase 2
• First received: January 5, 2005
• Last updated: January 10, 2006
• Start date: April 2004
• Est. completion date: July 2005

Study information

• Verified date: January 2006
• Source: VaxGen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: July 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anthrax

Intervention

Biological:
• rPA102

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
VaxGen	Centers for Disease Control and Prevention, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and immune response to vaccine.