Prevention of Anthrax Infection Clinical Trial
Official title:
A Phase 1 Trial to Evaluate the Safety and Immunogenicity of an Anthrax Recombinant Protective Antigen Vaccine
| NCT number | NCT00103467 |
| Other study ID # | VAX005 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 1 |
| First received | February 8, 2005 |
| Last updated | June 23, 2005 |
| Start date | June 2003 |
| Verified date | February 2005 |
| Source | VaxGen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 40 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | Emory University School of Medicine | Atlanta | Georgia |
| United States | Dept. of International Health - Johns Hopkins University Bloomberg School of Public Health | Baltimore | Maryland |
| United States | Baylor College of Medicine | Houston | Texas |
| United States | St. Louis University - SoLutions/SLUtest | St. Louis | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| VaxGen |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety and immunogenicity of 3 doses over 4 different dose ranges. |