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

Launched by LIVERPOOL SCHOOL OF TROPICAL MEDICINE · Dec 18, 2023

Keywords

ClinConnect Summary

This clinical trial, called the BCG-Controlled Human Infection Model (BCG-CHIM), is studying how the BCG vaccine, which is currently the only licensed vaccine for tuberculosis (TB), can help researchers understand more about TB and test new vaccines. TB is a serious disease that still affects millions of people worldwide, and finding an effective vaccine is crucial. In this trial, healthy adults aged 18 to 50 who live near the Queen Elizabeth Central Hospital in Blantyre, Malawi, might be eligible to participate. Participants will need to allow researchers to review their medical history and will need to be fluent in English or Chichewa to ensure they fully understand the study.

During the study, participants will receive a safe form of the BCG vaccine and will be closely monitored to see how their bodies respond. It’s important to note that some individuals may not qualify for the trial if they have certain health conditions, are pregnant, or have recently smoked or consumed alcohol in significant amounts. This study is not yet recruiting participants, but it aims to provide valuable insights into TB and pave the way for new vaccines in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy adults aged 18-50 (inclusive)
• • Resident near QECH, Blantyre (\<1 hour drive) for the duration of the study period
• • Allows the investigators to review the volunteer's medical history in the health passport book.
• • Females of childbearing potential with a negative urine pregnancy test at screening and willing to practice adequate birth control measures during the study.
• • Fluent spoken English or Chichewa - to ensure a comprehensive understanding of the research project and their proposed involvement.
• • Capacity to provide informed consent before joining the study.
• • Able and willing (in the investigators opinion) to comply with all the study requirements.
• Exclusion Criteria:
• • Laboratory evidence at screening of subclinical M. tb infection as indicated by a positive ELISPOT response to ESAT-6 or CFP-10 antigens. Volunteers discovered to have evidence of latent M. tb infection as defined by a positive ELISPOT test will be referred to the chest clinic for investigation for tuberculosis according to Malawi standard protocols.
• • Clinical, radiological, or laboratory evidence of current active TB disease
• • Clinically significant history of skin disorder, allergy, immunodeficiency (including HIV), cancer, cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness, or psychiatric disorder.
• • Current medical issues. Volunteers who are excluded from the study because they have been discovered to have a previously undiagnosed condition thought to require further medical attention will be referred appropriately to QECH specialist services for further investigation and treatment.
• • Acute respiratory tract infection in the four weeks preceding recruitment
• • Any uncontrolled medical or surgical condition at the discretion of the study doctor
• • Female participants who are pregnant, or intending to become pregnant, lactating or who Female participants who are unable to take contraception measures during the study.
• • Smoking: Current (defined as ≥5/week) or ex-smoker (cigarettes / cigars / smoking of recreational drugs) in the last 6 months. Previous significant smoking history (more than 20 cigarettes per day for 20 years or the equivalent \[\>20 pack years\]).Current alcohol and recreational drug use
• • Regularly drinks ≥3units/day (male) or ≥2units/day (female)
• • Uses recreational drugs.
• • Participants may be excluded at the discretion of the research clinician.
• • Concurrent oral or systemic steroid medication or the concurrent use of other immunosuppressive agents
• • History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the challenge agent.
• • Has received any vaccination within one month of screening visit.
• • Any abnormality of screening blood or urine tests that is deemed to be clinically significant or that may compromise the safety of the volunteer in the study.
• • Current involvement in another trial that involves regular blood tests or an investigational medicinal product.
• • Use of an investigational medicinal product or non-registered drug, live vaccine, or investigational medical device for four weeks prior to dosing with the study challenge agent
• • Participants who meet STOP criteria at the time of screening (see table 4)
• • Any other issue which, in the opinion of the study staff, may
• • Put the participant or their contacts at risk because of participation in the study,
• • Adversely affect the interpretation of the study results, or
• • Impair the participant's ability to participate in the study.