Study of Immune Responses to COVID-19 Vaccines in Adults with Tuberculosis Compared to Healthy Adults

What this Trial Is About

Researchers are examining the immune response to COVID-19 vaccines in two groups people with bacteriologically confirmed tuberculosis TB who are receiving treatment, and healthy individuals. This observational study aims to compare the humoral and cellular immune responses after vaccination with Pfizer-BioNTech, AstraZeneca, or Janssen COVID-19 vaccines. Understanding vaccine response in TB patients is important because both COVID-19 and TB affect the respiratory system and can lead to severe complications, especially in vulnerable groups. Participants will receive one or two doses of a COVID-19 vaccine in the non-dominant arm, depending on the vaccine type. Pfizer-BioNTech and AstraZeneca vaccines require two doses spaced 3 weeks and 12 weeks apart, respectively, while the Janssen vaccine requires a single dose. The study includes two groups TB patients under treatment and healthy individuals, both receiving vaccines as part of community vaccination efforts. Follow-up visits are scheduled at specific intervals after vaccination to monitor immune responses and safety. During the study, participants will undergo blood tests to measure antibody levels and immune cell responses before and after vaccination. Safety assessments include monitoring for local and systemic reactions for seven days post-vaccination and recording any adverse events over the study period. Lab tests for liver, kidney function, and infection screening will be performed initially and at follow-up points. The study duration is approximately one year to allow comprehensive evaluation of vaccine immunogenicity and safety in both TB patients and healthy controls.

Immunogenicity of COVID-19 Vaccines in Tuberculosis Patients