Immunogenicity of COVID-19 Vaccines Against Coronavirus Disease (COVID-19) Among Tuberculosis (TB) Patients in Thailand-Myanmar Border.
This study is a non-randomized observation and comparison of immune response between bacteriologically confirmed TB patients under treatment cohort who received COVID-19 vaccine (n=54) vs healthy individuals (n=54). Each participant will receive single or double doses of one of COVID-19 vaccines (Pfizer-BioNTech COVID-19 vaccine, AstraZeneca vaccine or Janssen Ad26.COV2.S COVID-19 vaccine) in the deltoid muscle of the non-dominant arm. Study Duration approximately 1 year. The main focus of this study is to compare the humoral and cellular immunological responses of the COVID-19 vaccines between bacteriologically confirmed TB patients under treatment vs healthy individuals. This study is funded by the Wellcome Trust. The grant reference number is 220211/A/20/Z.
• 18 years and above, newly diagnosed bacteriologically confirmed TB patients including both drug sensitive and resistant TB, who are taking anti TB or MDR-TB treatment in initial period during study period or clinically healthy individuals for comparator arm.
• Willing to be followed for four weeks following second dose of Pfizer-BioNTech COVID-19 vaccine and AstraZeneca vaccine or eight weeks following single dose of Janssen Ad26.COV2.S COVID-19 vaccine
• Willing to be involved in the pre-enrolment screening.
• For women with child bearing potential only (aged 18-49 years), willing to continue to use effective contraception methods through the study.
• For women with child bearing potential only (aged 18-49 years), negative pregnancy test on the day of screening and on the day of vaccination to be eligible to receive the vaccination.
• Able and willing to comply with all study requirements.
• Ability to understand the study instructions and provide written informed consent