Immunogenicity of COVID-19 Vaccines in Tuberculosis Patients

Prior treatment

• Participation in other vaccine trials within 90 days before and 30 days after the study vaccination.
• Administration of any immunoglobulins or any type of COVID-19 vaccine within 90 days before administration of the vaccine.
• Any previous history of a serious side effect with any kind of vaccine.

Other illness

• History of HIV infection
• Participation in other COVID-19 related studies for the duration of the study.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Any history of angioedema.
• Any history of anaphylaxis.
• Current diagnosis of or treatment for cancer.
• History of severe psychiatric disorders likely to affect participation in the study.
• Suspected or known current alcohol or drug dependency (except well controlled condition).
• Presence of any condition which in the judgement of the investigator would place the patient at undue risk or interfere with the results of the study.
• Severe and/or uncontrolled cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed).

Lab values

• History of laboratory confirmed COVID-19 for any duration before or positive COVID-19 PCR or antigenic test at screening.
• Bleeding disorder (e.g. coagulation factor deficiency, coagulopathy or platelet disorder), history of thrombosis or prior history of significant bleeding or bruising following IM injections or venipuncture.

Other

• Women with pregnancy, lactation or planning to get pregnant during the duration of the study.

• 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