MedTrace Logo

A Controlled Human Infection Model (CHIM) With Intradermal BCG in Malawi

NCT06178666 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-12-21

No results posted yet for this study

Summary

Despite tremendous efforts, an effective tuberculosis (TB) vaccine remains elusive. TB continues to infect and kill many. In 2021, TB infected more than 10 million and killed 1.6 million people. To date, the M.bovis bacille Calmette Guerin (BCG) is the only licensed vaccine against tuberculosis (TB). Efforts to come up with new and effective vaccines have not been successful. Partially, the lack of suitable disease models and protection correlates hinders the research of new vaccines. Controlled human infection model studies (CHIM) involve administering disease-causing microbes to healthy individuals, with continued monitoring of disease response. These studies have been used to study malaria, typhoid, pneumococcal pneumonia and the recent SARS-CoV-2 vaccines. The BCG-Controlled Human Infection Model (BCG-CHIM) will allow accurate dosing with safe mycobacteria as well as minimal tissue sampling to understand immunity to mycobacteria. Considering that the M. bovis BCG is a safe living Mycobacteria, it can be used as a CHIM against which to test new vaccines.

Conditions

Interventions

BIOLOGICAL

BCG

Three dose levels of intradermal BCG

Sponsors & Collaborators

  • Liverpool School of Tropical Medicine, United Kingdom

    collaborator UNKNOWN

  • Fred Hutchinson Cancer Center

    collaborator OTHER

  • University of Liverpool

    collaborator OTHER

  • Malawi-Liverpool-Wellcome Trust Clinical Research Programme

    collaborator OTHER

  • University of Oxford

    collaborator OTHER

  • Liverpool School of Tropical Medicine

    lead OTHER

Principal Investigators

  • Stephen Gordon, MD · Malawi Liverpool Wellcome Programme

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2025-03-01
Completion
2026-03-01

Countries

  • Malawi

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06178666 on ClinicalTrials.gov