Immunogenicity of COVID-19 Vaccines in Tuberculosis Patients
CVTB
1 other identifier
observational
133
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2022
CompletedFirst Posted
Study publicly available on registry
October 7, 2022
CompletedStudy Start
First participant enrolled
April 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
April 13, 2026
March 1, 2026
3.2 years
October 5, 2022
April 7, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Comparison of humoral and cellular responses to SARS-CoV-2 between bacteriologically confirmed TB patients under treatment vs healthy individuals at the end of the study
Day 49 in Pfizer-BioNTech COVID-19 vaccine, Day 112 in AstraZeneca vaccine or Day 56 in Janssen Ad26.COV2.S COVID-19 vaccine
Comparison of humoral and cellular responses to SARS-CoV-2 between bacteriologically confirmed TB patients under treatment vs healthy individuals.
Day 21 in Pfizer-BioNTech COVID-19 vaccine, Day 84 in AstraZeneca vaccine or Day 28 in Janssen Ad26.COV2.S COVID-19 vaccine
Secondary Outcomes (4)
Occurrence and comparison of solicited local reactogenicity signs and symptoms for 7 days following each dose of vaccination
7 Days
Occurrence and comparison of solicited systemic reactogenicity signs and symptoms for 7 days following each dose of vaccination
7 Days
Occurrence and comparison of unsolicited adverse events (AEs) following each dose of vaccination
Day 0, Day 7, Day 21, Day 28, Day 49, Day 56, Day 84, Day 112 in each vaccination
Comparison of changes from baseline for safety laboratory measures between bacteriologically confirmed TB patients under treatment vs healthy individuals.
Day 0, Day 21, Day 28, Day 84
Study Arms (2)
TB cohort
TB cohort - Bacteriologically confirmed TB patients (18 years and above) One of the following three COVID-19 vaccines will be provided based on availability of supply from the Ministry of public health, Thailand as an intervention for the study.
Healthy comparator
Comparator- Clinically healthy individuals (54 in healthy comparator) One of the following three COVID-19 vaccines will be provided based on availability of supply from the Ministry of public health, Thailand as an intervention for the study.
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)
Eligibility Criteria
TB cohort - Bacteriologically confirmed TB patients (54 in cohort of patients) Comparator- Clinically healthy individuals (54 in healthy comparator)
You may qualify if:
- 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
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shoklo Malaria Research Unit (SMRU)
Mae Ramat, Changwat Tak, Thailand
Biospecimen
Leftover blood specimens will be stored for possible confirmatory or additional testing. In the event that the stored specimen is used for purposes that may or may not be related to this study. SMRU will be responsible for obtaining the necessary ethical approvals. Samples stored for future use will be anonymized using a standard operating procedure (SOP) and coded so that no identification of the subject is possible. Stored samples will be destroyed after a maximum of 10 years after study close. Sample disposal will be done as per related SOPs.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
François Nosten, Professor
Shoklo Malaria Research Unit
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2022
First Posted
October 7, 2022
Study Start
April 15, 2023
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
April 13, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
All personal details of participants will be de-identified. These data including laboratory investigation results will be stored and may be shared to other researchers to apply in their research in accordance with the MORU data sharing policy.