Immunogenicity of COVID-19 Vaccines in Tuberculosis Patients
Immunogenicity of COVID-19 Vaccines Against Coronavirus Disease (COVID-19) Among Tuberculosis (TB) Patients in Thailand-Myanmar Border.
University of Oxford
133 participants
Apr 15, 2023
OBSERVATIONAL
Conditions
Summary
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
Inclusion Criteria7
- 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 Criteria16
- 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).
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Interventions
Pfizer-BioNTech COVID-19 vaccine, Messenger RNA (mRNA) based vaccine encoding the viral spike glycoprotein (S) Formulation: Frozen concentrate before dilution with 0.9% sodium chloride solution for injection Route of Administration: Intramuscular (IM) Dosing regimen: Two doses (0.3 mL per dose) (at least 3 weeks apart)
AstraZeneca vaccine, a replication-deficient simian adenoviral vector expressing the spike (S) protein of SARS-CoV-2 Formulation: Aqueous solution for injection Route of Administration: Intramuscular (IM) Dosing regimen: Two doses (0.5 mL per dose) (at least 12 weeks apart)
Janssen Ad26.COV2.S COVID-19 vaccine, recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein. Formulation: Suspension for injection Route of Administration: Intramuscular (IM) Dosing regimen single dose (0.5 mL)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05571735