Clinical trial NCT00100724: Trial of rPA-102 Vaccine in Healthy Adult Volunteers
Official title: A Phase 2 Multi-Center, Randomized Dose-Finding Trial of rPA-102 Vaccine in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anthrax
Keywords: Anthrax
rPA102
vaccine
Lead sponsor: VaxGen
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Centers for Disease Control and Prevention
First posted: 2005-01-06
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Safety and immune response to vaccine.
Secondary outcomes:
Other outcomes:
Locations:
city: Torrance
country: United States
facility: UCLA Ctr for Vaccine Research, LA Biomedical Research Institute
state: California
city: Atlanta
country: United States
facility: Emory Children's Clinic, Pediatric Infectious Disease
state: Georgia
city: Lexington
country: United States
facility: University of Kentucky, Markey Cancer Center
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University, Bloomberg School of Public Health
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic College of Medicine
state: Minnesota
city: St. Louis
country: United States
facility: St. Louis University, SoLUtions
state: Missouri
city: Rochester
country: United States
facility: Infectious Disease Unit, University of Rochester Medical Center
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Pediatric Clinical Trials Int'l, Inc. (PCTI)
state: Ohio
city: Pittsburgh
country: United States
facility: Primary Physicians Research, Inc.
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Burlington
country: United States
facility: University of Vermont College of Medicine, Vermont Vaccine Evaluation Center
state: Vermont
Study officials:
References: