Immunogenicity of COVID-19 Vaccines in Tuberculosis Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Oxford
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Pfizer-BioNTech COVID-19 vaccine
- AstraZeneca vaccine
- Janssen Ad26.COV2.S COVID-19 vaccine
Treatment groups
133 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov