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Immunogenicity of COVID-19 Vaccines in Tuberculosis Patients

RecruitingN/A

Sponsor: University of Oxford

Conditions: Covid-19 Pandemics, Tuberculosis

Interventions: Pfizer-BioNTech COVID-19 vaccine, AstraZeneca vaccine, Janssen Ad26.COV2.S COVID-19 vaccine

Countries: Thailand

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* History of laboratory confirmed COVID-19 for any duration before or positive COVID-19 PCR or antigenic test at screening.
* History of HIV infection
* Participation in other COVID-19 related studies for the duration of the study.
* 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.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Any previous history of a serious side effect with any kind of vaccine.
* Any history of angioedema.
* Any history of anaphylaxis.
* Women with pregnancy, lactation or planning to get pregnant during the duration of the study.
* Current diagnosis of or treatment for cancer.
* History of severe psychiatric disorders likely to affect participation in the study.
* 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.
* 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).

Locations (1)

Mae Ramat, Changwat Tak, Thailand