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Immunogenicity of COVID-19 Vaccines in Tuberculosis Patients

NCT05571735 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 133

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Pfizer-BioNTech COVID-19 vaccine

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)

BIOLOGICAL

AstraZeneca vaccine

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)

BIOLOGICAL

Janssen Ad26.COV2.S COVID-19 vaccine

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)

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • François Nosten, Professor · Shoklo Malaria Research Unit

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-15
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Thailand

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05571735 on ClinicalTrials.gov