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Trial of rPA-102 Vaccine in Healthy Adult Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00100724
Recruitment Status : Completed
First Posted : January 6, 2005
Last Update Posted : January 12, 2006
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Centers for Disease Control and Prevention
Information provided by:
VaxGen

Tracking Information
First Submitted Date  ICMJE January 5, 2005
First Posted Date  ICMJE January 6, 2005
Last Update Posted Date January 12, 2006
Study Start Date  ICMJE April 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Safety and immune response to vaccine.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of rPA-102 Vaccine in Healthy Adult Volunteers
Official Title  ICMJE A Phase 2 Multi-Center, Randomized Dose-Finding Trial of rPA-102 Vaccine in Healthy Adult Volunteers
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Anthrax
Intervention  ICMJE Biological: rPA102
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 29, 2005)
480
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE July 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00100724
Other Study ID Numbers  ICMJE VAX006
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE VaxGen
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Centers for Disease Control and Prevention
Investigators  ICMJE Not Provided
PRS Account VaxGen
Verification Date January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP