Trial of rPA-102 Vaccine in Healthy Adult Volunteers

January 10, 2006 updated by: VaxGen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

480

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety and immune response to vaccine.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VaxGen

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
Centers for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Study Completion

July 1, 2005

Study Registration Dates

First Submitted

January 5, 2005

First Submitted That Met QC Criteria

January 5, 2005

First Posted (Estimate)

January 6, 2005

Study Record Updates

Last Update Posted (Estimate)

January 12, 2006

Last Update Submitted That Met QC Criteria

January 10, 2006

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAX006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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