Status:
COMPLETED
A Phase I/IIa AERAS-456 in HIV-Negative Adults With & Without Latent Tuberculosis Infection (C-035-456)
Lead Sponsor:
Aeras
Collaborating Sponsors:
Statens Serum Institut
Conditions:
Latent Tuberculosis Bacteriology and Histology Unknown
Latent Tuberculosis
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a Phase I/IIa, double-blind, randomized, placebo-controlled, dose- and regimen-finding study in healthy adults with and without LTBI, who are BCG-vaccinated, HIV negative, and have no history ...
Detailed Description
This is a Phase I/IIa, double-blind, randomized, placebo-controlled, dose- and regimen-finding study in healthy adults with and without latent Tuberculosis (TB) Infection, who are Bacille Calmette Gue...
Eligibility Criteria
Inclusion
- Subjects must meet all of the following criteria prior to Study Day 0 vaccination:
- Has completed the written informed consent process prior to the start of screening evaluations.
- Is male or female.
- Is age 18 through 50 years at the time of randomization.
- Received BCG vaccination at least 5 years prior to randomization.
- Females: Ability to avoid pregnancy during the trial: Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must avoid pregnancy with an acceptable method of avoiding pregnancy from 28 days prior to administration of the study vaccine through the end of the study.
- Has general good health, confirmed by medical history and physical examination at screening.
- Is able and willing to complete the full follow-up period of 292 days as required by the protocol.
- Agrees to avoid elective surgery for the full duration of the study.
- \[Groups 1 and 2\] Does not have LTBI, determined by a negative QFT at screening or\[Groups 3 and 4\] Has LTBI, determined by a positive QFT at screening.
Exclusion
- Subjects must meet none of the following criteria prior to Study Day 0 vaccination:
- Acute illness at the time of randomization.
- Oral temperature 37.5 degrees C at the time of randomization.
- Abnormal laboratory values from blood collected within 21 days prior to Study Day 0 vaccination.
- Abnormal urinalysis that, in the opinion of the investigator, indicates systemic or local disease.
- History or evidence of tuberculosis disease, including but not limited to pulmonary tuberculosis, pleural tuberculosis, lymph node tuberculosis or tuberculosis meningitis.
- Received a TST within 21 days prior to a scheduled study vaccination.
- Received investigational Mtb vaccine at any time prior to Study Day 0.
- History or evidence of autoimmune disease.
- History or laboratory evidence of HIV-1 infection at screening.
- Positive test for hepatitis B surface antigen or hepatitis C antibody at screening.
- Used immunosuppressive medication (other than inhaled or topical immunosuppressants) within 21 days prior to Study Day 0.
- Received immunoglobulin or blood products within 21 days prior to Study Day 0.
- Received any investigational product within 21 days prior to Study Day 0, or plans to participate in any other study involving administration of investigational product during the study period.
- Inability to discontinue current chronic prescription medications, except contraceptives, inhaled or topical immunosuppressants, or nutritional supplements, during the study period.
- Documented history of allergic reaction or hypersensitivity to any component of the study vaccine.
- All female subjects: currently pregnant or lactating/nursing; or positive serum pregnancy test during screening; or positive urine pregnancy test on the day of any study vaccination.
- History or evidence of any systemic disease or any acute or chronic illness that, in the opinion of the investigator, may compromise the safety of the subject in the study or interfere with the evaluation of the safety or immunogenicity of the vaccine.
- History of dermatologic disease or skin features that, in the opinion of the investigator, may interfere with the assessment of injection site reactions.
- History or evidence of any medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, will make it unlikely that the subject will comply with the protocol.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT01865487
Start Date
August 1 2013
End Date
November 1 2015
Last Update
December 19 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
eKhayavac TB Vaccine Trial
Khayelitsha, Cape Town, South Africa, 7784
2
SATVI Project Office, Brewelskloof Hospital
Worcester, South Africa, 6850