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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04152161
Recruitment Status : Active, not recruiting
First Posted : November 5, 2019
Last Update Posted : August 11, 2021
Sponsor:
Information provided by (Responsible Party):
Bill & Melinda Gates Medical Research Institute

Tracking Information
First Submitted Date  ICMJE October 22, 2019
First Posted Date  ICMJE November 5, 2019
Last Update Posted Date August 11, 2021
Actual Study Start Date  ICMJE October 16, 2019
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2019)
  • 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 ]
  • Number of Participants With Solicited Adverse Events (AEs) [ Time Frame: Day 1 through 7 days post vaccination ]
  • Number of Participants With Unsolicited AEs [ Time Frame: Day 1 through 28 days post vaccination ]
  • Number of Participants With Serious Adverse Events [ Time Frame: Day 1 through Month 6 ]
  • Number of Participants With AEs of Special Interest [ Time Frame: Day 1 through Month 6 ]
  • Number of Participants With Serious Adverse Drug Reactions [ Time Frame: Day 1 through end of study participation i.e. approximately 48 months ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BCG Revaccination of Healthy Adolescents for the Prevention of Mycobacterium Tuberculosis Sustained Infection
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Tuberculosis
Intervention  ICMJE
  • 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.
  • Biological: Placebo
    Participants will receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.
Study Arms  ICMJE
  • Experimental: Bacille Calmette Guerin (BCG) group
    Intervention: Biological: BCG vaccine SSI
  • Placebo Comparator: Placebo group
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 10, 2021)
1820
Original Estimated Enrollment  ICMJE
 (submitted: November 1, 2019)
1800
Estimated Study Completion Date  ICMJE January 22, 2026
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 . 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., 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04152161
Other Study ID Numbers  ICMJE Gates MRI-TBV01-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Current Responsible Party Bill & Melinda Gates Medical Research Institute
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bill & Melinda Gates Medical Research Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gates MRI Bill & Melinda Gates Medical Research Institute
PRS Account Bill & Melinda Gates Medical Research Institute
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP