Immunogenicity of COVID-19 Vaccines in Tuberculosis Patients

Ki vehet részt

• 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

Ki nem vehet részt

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