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BCG Revaccination of Healthy Adolescents for the Prevention of Mycobacterium Tuberculosis Sustained Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04152161
Recruitment Status : Recruiting
First Posted : November 5, 2019
Last Update Posted : January 10, 2020
Sponsor:
Information provided by (Responsible Party):
Bill & Melinda Gates Medical Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Tuberculosis Biological: BCG vaccine SSI Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Placebo Controlled, Observer-Blind, Phase IIb Study to Evaluate the Efficacy, Safety, and Immunogenicity of BCG Revaccination in Healthy Adolescents for the Prevention of Sustained Infection With Mycobacterium Tuberculosis
Actual Study Start Date : October 16, 2019
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bacille Calmette Guerin (BCG) group Biological: BCG vaccine SSI
Participants will receive a single 0.1 milliliter (mL) volume of BCG vaccine SSI, administered intradermally in deltoid region of the upper arm.

Placebo Comparator: Placebo group Biological: Placebo
Participants will receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.




Primary Outcome Measures :
  1. Number of Participants With Sustained QuantiFERON®-TB Gold Plus Assay (QFT) Conversion From a Negative to Positive Test Based on an Interferon Gamma (IFN-γ) Concentration cut-off Value of 0.35 International Units per Milliliter (IU/mL) [ Time Frame: Up to 48 months ]
    Sustained Conversion means initial conversion and QFT Positive 3 and 6 months later.


Secondary Outcome Measures :
  1. Number of Participants with Sustained QFT Conversion From a Negative to Positive Test Based on an IFN-γ Concentration cut-off Level of 0.35 IU/mL [ Time Frame: Initial conversion and QFT-positive at 3- and 6-months post conversion, with a minimum follow-up of 36- and 48-months post vaccination ]
  2. Number of Participants With Solicited Adverse Events (AEs) [ Time Frame: Day 1 through 7 days post vaccination ]
  3. Number of Participants With Unsolicited AEs [ Time Frame: Day 1 through 28 days post vaccination ]
  4. Number of Participants With Serious Adverse Events [ Time Frame: Day 1 through Month 6 ]
  5. Number of Participants With AEs of Special Interest [ Time Frame: Day 1 through Month 6 ]
  6. Number of Participants With Serious Adverse Drug Reactions [ Time Frame: Day 1 through end of study participation i.e. approximately 48 months ]
  7. Primary QFT Conversion From a Negative to Positive Test Based on a QFT IFN-γ Concentration cut-off Value of 4 IU/mL (Initial Conversion Only) [ Time Frame: At the time of primary endpoint analysis, anticipated to occur within 3.5 years of study start, and after a minimum follow-up of 36- and 48-months post vaccination ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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, using the manufacturer's recommended threshold of 0.35 international units per milliliter
  • 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
  • Body temperature ≥37.5 degree Celsius on Study Day 1
  • 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., 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04152161


Contacts
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Contact: Gates MRI 857-702-2108 info@gatesmri.org

Locations
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South Africa
Investigational Site Recruiting
Klipfontein, Cape Town, South Africa, 7750
Investigational Site Recruiting
Berea, Durban, South Africa, 4001
Investigational Site Recruiting
Hillbrow, Johannesburg, South Africa, 2001
Investigational Site Recruiting
Paarl, Western Cape, South Africa, 7626
Investigational Site Recruiting
Worcester, Western Cape, South Africa, 6850
Sponsors and Collaborators
Bill & Melinda Gates Medical Research Institute
Investigators
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Study Director: Gates MRI Bill and Melinda Gates Medical Research Institute

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Responsible Party: Bill & Melinda Gates Medical Research Institute
ClinicalTrials.gov Identifier: NCT04152161    
Other Study ID Numbers: Gates MRI-TBV01-201
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Bill & Melinda Gates Medical Research Institute:
Mycobacterium tuberculosis infection
Healthy adolescents
Healthy participants
BCG vaccine
Additional relevant MeSH terms:
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Infection
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
BCG Vaccine
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic