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


Phase 2
18 Years
55 Years
Not Enrolling
Both
Anthrax

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety and immune response to vaccine.

Authority:

United States: Food and Drug Administration

Study ID:

VAX006

NCT ID:

NCT00100724

Start Date:

April 2004

Completion Date:

July 2005

Related Keywords:

  • Anthrax
  • Anthrax
  • rPA102
  • vaccine
  • Anthrax

Name

Location

Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Vanderbilt University Medical CenterNashville, Tennessee  37232-2516
UCLA Ctr for Vaccine Research, LA Biomedical Research InstituteTorrance, California  90502
Emory Children's Clinic, Pediatric Infectious DiseaseAtlanta, Georgia  30322
University of Kentucky, Markey Cancer CenterLexington, Kentucky  40536-0093
Johns Hopkins University, Bloomberg School of Public HealthBaltimore, Maryland  21205
Mayo Clinic College of MedicineRochester, Minnesota  55905
St. Louis University, SoLUtionsSt. Louis, Missouri  63104
Infectious Disease Unit, University of Rochester Medical CenterRochester, New York  14642
Pediatric Clinical Trials Int'l, Inc. (PCTI)Columbus, Ohio  43205
Primary Physicians Research, Inc.Pittsburgh, Pennsylvania  15241
University of Vermont College of Medicine, Vermont Vaccine Evaluation CenterBurlington, Vermont  05405