Trial of rPA-102 Vaccine in Healthy Adult Volunteers

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
VaxGen
ClinicalTrials.gov Identifier:
NCT00100724
First received: January 5, 2005
Last updated: January 10, 2006
Last verified: January 2006
  Purpose

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.


Condition Intervention Phase
Anthrax
Biological: rPA102
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Phase 2 Multi-Center, Randomized Dose-Finding Trial of rPA-102 Vaccine in Healthy Adult Volunteers

Resource links provided by NLM:


Further study details as provided by VaxGen:

Primary Outcome Measures:
  • Safety and immune response to vaccine.

Estimated Enrollment: 480
Study Start Date: April 2004
Estimated Study Completion Date: July 2005
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00100724

Locations
United States, California
UCLA Ctr for Vaccine Research, LA Biomedical Research Institute
Torrance, California, United States, 90502
United States, Georgia
Emory Children's Clinic, Pediatric Infectious Disease
Atlanta, Georgia, United States, 30322
United States, Kentucky
University of Kentucky, Markey Cancer Center
Lexington, Kentucky, United States, 40536-0093
United States, Maryland
Johns Hopkins University, Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205
United States, Minnesota
Mayo Clinic College of Medicine
Rochester, Minnesota, United States, 55905
United States, Missouri
St. Louis University, SoLUtions
St. Louis, Missouri, United States, 63104
United States, New York
Infectious Disease Unit, University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Pediatric Clinical Trials Int'l, Inc. (PCTI)
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Primary Physicians Research, Inc.
Pittsburgh, Pennsylvania, United States, 15241
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Vermont
University of Vermont College of Medicine, Vermont Vaccine Evaluation Center
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
VaxGen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00100724     History of Changes
Other Study ID Numbers: VAX006
Study First Received: January 5, 2005
Last Updated: January 10, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by VaxGen:
Anthrax
rPA102
vaccine

Additional relevant MeSH terms:
Anthrax
Bacillaceae Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on August 20, 2014