Trial to Evaluate the Safety and Immunogenicity of an Anthrax Recombinant Protective Antigen Vaccine

This study has been completed.
Sponsor:
Information provided by:
VaxGen
ClinicalTrials.gov Identifier:
NCT00103467
First received: February 8, 2005
Last updated: June 23, 2005
Last verified: February 2005
  Purpose

The purpose of this phase 1 study is to evaluate the safety and immunogenicity of rPA102 vaccine, using anthrax vaccine adsorbed (AVA) as a comparator.


Condition Intervention Phase
Prevention of Anthrax Infection
Biological: rPA102 Vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Phase 1 Trial to Evaluate the Safety and Immunogenicity of an Anthrax Recombinant Protective Antigen Vaccine

Resource links provided by NLM:


Further study details as provided by VaxGen:

Primary Outcome Measures:
  • Safety and immunogenicity of 3 doses over 4 different dose ranges.

Estimated Enrollment: 100
Study Start Date: June 2003
  Eligibility

Ages Eligible for Study:   18 Years to 40 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 to 40 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 3 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.
  • Expected to be noncompliant with study visits or planning to move within 8 months.
  • Body mass index of >35 or <19.
  • Known allergy to aluminum hydroxide, formaldehyde, benzethonium chloride, latex, kanamycin, or any other aminoglycoside antibiotics (such as gentamycin).
  • 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 of study vaccination.
  • Received, or plans to receive, systemic immunosuppresive therapy, radiation therapy, or high-dose inhaled steroids within 30 days of study vaccination.
  • Use of systemic chemotherapy 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103467

Locations
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
United States, Maryland
Dept. of International Health - Johns Hopkins University Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205
United States, Missouri
St. Louis University - SoLutions/SLUtest
St. Louis, Missouri, United States, 63104
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
VaxGen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00103467     History of Changes
Other Study ID Numbers: VAX005
Study First Received: February 8, 2005
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 22, 2014