A Phase I Randomized Placebo-Controlled, Double-Blind Study to Evaluate Safety and Immunogenicity of AERAS-402 When Administered to HIV-Negative BCG-Vaccinated Adults Without Evidence of Tuberculosis Infection
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Tuberculosis
- Sponsor
- Aeras
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Number and Percentage of Adverse Events by treatment group
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
This Phase I study will be conducted as a randomized, double-blind, placebo-controlled study in healthy adult subjects who are HIV-negative, BCG-vaccinated, and have no evidence of tuberculosis infection. The study will be conducted at one clinical research site in India.
The available live tuberculosis vaccine, Bacillus Calmette-Guérin (BCG), provides incomplete protection against pulmonary tuberculosis. For unknown reasons, a BCG revaccination or "booster", while not toxic, does not provide much additional protection. AERAS-402 presents tuberculosis antigens in the setting of a new, live, replication-deficient adenovirus vaccine that may increase T cell-mediated immunity and thus protection from tuberculosis. Since BCG-vaccinated individuals are the population for which AERAS-402 might be indicated, AERAS-402 will be administered to individuals already vaccinated with BCG.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Is male or female
- •Is age 18 through 45 years on Study Day 0
- •Has completed written informed consent
- •Had BCG vaccination at least 5 years ago, documented through medical history or presence of scar
- •Has general good health, confirmed by medical history and physical examination
- •Has Body Mass Index (BMI) between 19 and 30 (kg/m2)
- •Has ability to complete follow-up period of 182 days as required by the protocol
- •Females: Ability to avoid pregnancy from 28-days prior to initial study vaccination through the duration of their participation in the study.
- •Will commit to avoiding elective surgery for the duration of the study
- •Has ability to stay in contact with the investigative site for the duration of the study
Exclusion Criteria
- •Acute illness on the day of randomization
- •Oral temperature ≥37.5°C on the day of randomization
- •Evidence of significant active infection
- •Used immunosuppressive medication within 42 days before entry into the study
- •Received immunoglobulin or blood products within 42 days
- •Received any investigational drug therapy or vaccine within 182 days
- •Received any standard vaccine within 42 days
- •Participated in any clinical trial of an investigational adenovirus-based vaccine previously.
- •Current chronic drug therapy
- •History or laboratory evidence of any past, present or future possible immunodeficiency state which will include (but is not limited to) any laboratory indication of HIV infection
Outcomes
Primary Outcomes
Number and Percentage of Adverse Events by treatment group
Time Frame: Day 56
The number and percentage of Adverse Events will be presented and compared by treatment group (placebo vs AERAS 402).
Secondary Outcomes
- Immune Response(Day 182)