Bacille Calmette Guerin (BCG) Revaccination of Healthy Adolescents for the Prevention of Mycobact… (NCT04152161) | Clinical Trial Compass
TerminatedPhase 2
Bacille Calmette Guerin (BCG) Revaccination of Healthy Adolescents for the Prevention of Mycobacterium Tuberculosis Sustained Infection
Stopped: Sponsor decision
South Africa1,836 participantsStarted 2019-10-16
Plain-language summary
The purpose of this study is to demonstrate the efficacy of Bacille Calmette Guerin (BCG) revaccination against sustained Mycobacterium tuberculosis infection versus placebo in previously BCG vaccinated QuantiFERON®-TB Gold Plus Assay (QFT) negative, healthy adolescents.
Who can participate
Age range10 Years – 18 Years
SexALL
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Inclusion Criteria:
* Participant between ≥ 10 years and ≤ 18 years on Study Day 1
* General good health, confirmed by medical history and physical examination
* Vaccinated with Bacille Calmette Guerin (BCG) at least 5 years ago, documented through medical history or by presence of healed BCG scar
* Tests QuantiFERON®-TB Gold Plus Assay (QFT) negative at screening.
* For female participants: not pregnant and agrees to avoid pregnancy throughout the first 12 months of the study. Women physically capable of pregnancy must agree to use an acceptable method of avoiding pregnancy during this period. Acceptable methods of avoiding pregnancy include sexual abstinence (not engaging in sexual intercourse), a confirmed sterile partner, or at least 2 contraception methods from the following list: male or female condom, diaphragm, intrauterine devices (IUDs), hormonal contraceptive (oral, injection, transdermal patch, or implant).
* Agrees to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study
* Capable of giving signed informed consent/assent and completes the written informed consent/assent process.
Exclusion Criteria:
* Acute illness on Study Day 1. NOTE: This is a temporary exclusion for which the participant may be re-evaluated
* Body temperature ≥37.5 degree Celsius on Study Day 1. NOTE: This is a temporary exclusion for which the pa…
What they're measuring
1
Number of Participants With Sustained QuantiFERON®-TB Gold Plus Assay (QFT) Conversion From a Negative to Positive Test Based on Positive QFT Test Results