Bacille Calmette Guerin (BCG) Revaccination of Healthy Adolescents for the Prevention of Mycobacterium Tuberculosis Sustained Infection

Launched by GATES MEDICAL RESEARCH INSTITUTE · Nov 1, 2019

Keywords

ClinConnect Summary

This clinical trial is studying whether revaccinating healthy adolescents with the Bacille Calmette Guerin (BCG) vaccine can help prevent a sustained infection from tuberculosis, a serious lung disease, compared to a placebo (a treatment that has no active effect). The trial is currently active but not recruiting new participants and is specifically looking for adolescents aged 10 to 18 years who have received the BCG vaccine at least five years ago and are in good health. Participants must also test negative for tuberculosis infection before joining the study.

Eligible participants can expect to receive either the BCG revaccination or a placebo during the trial. They will need to stay in touch with the study site and follow certain guidelines, such as avoiding pregnancy for the first year of the study if they are female. It’s important to note that some individuals may not qualify for the study based on their health history, such as those with a recent illness, active tuberculosis, or certain autoimmune diseases. Overall, this trial aims to find ways to better protect young people from tuberculosis infections.

Gender

ALL

Eligibility criteria

• 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 participant may be re-evaluated
• • History or evidence of any clinically significant disease, including severe eczema and severe asthma, or any acute or chronic illness that might affect the safety, immunogenicity, or efficacy of study vaccine in the opinion of the investigator
• • Any current medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, will make it unlikely that the participant will comply with the protocol
• • History of autoimmune disease
• • History or evidence of active tuberculosis (TB) disease
• • History or laboratory evidence of any past or present possible immunodeficiency state including, but not limited to, any laboratory indication of human immunodeficiency virus - 1 (HIV-1) infection
• • History of allergic disease that is likely to be exacerbated by any component of the study vaccine
• • History of treatment for active TB disease or history of latent Mycobacterium tuberculosis infection
• • Received a tuberculin skin test within 6 months prior to Study Day 1
• • Received immunosuppressive treatment, e.g., chemotherapy, biologics or radiation therapy, or used immunosuppressive medication (daily steroid equivalent of ≥5 milligrams prednisone) within 42 days before Study Day 1. Inhaled and topical corticosteroids are permitted.
• • Received immunoglobulin or blood products within 42 days before Study Day 1
• • Planned administration/administration of a licensed vaccine in the period starting 28 days before and ending 28 days after Study Day 1
• • Received investigational TB vaccine at any time prior to Study Day 1
• • Received any investigational drug therapy or investigational vaccine within 180 days before Study Day 1, or planned participation in any other clinical trial using investigational product during the study period
• • Laboratory values from the most recent blood collected prior to randomization outside the normal range that are suggestive of a disease state. Grade 1 abnormalities (as per Division of Acquired Immunodeficiency Syndrome toxicity table version 2.1) do not lead to exclusion if the investigator considers them not clinically significant
• • Urinalysis abnormality greater than Grade 1 on the Toxicity Scale (with the exception of hematuria in a menstruating female), or urinalysis abnormality judged clinically significant by the investigator
• • Shared residence with an individual who is receiving TB treatment or with someone who is known to have incompletely treated TB. e.g., Xpert Mycobacterium tuberculosis (MTB)/rifampicin (RIF) assay-positive, polymerase chain reaction-positive, culture-positive, smear-positive TB, or clinically diagnosed unconfirmed TB
• • Child in Care
• • Female participants currently pregnant or lactating/nursing; or positive serum pregnancy test during screening or on Day 1, prior to vaccination, or planning a pregnancy within the first 12 months after study intervention