Immunogenicity of COVID-19 Vaccines Against Coronavirus Disease (COVID-19) Among Tuberculosis (TB) Patients in Thailand-Myanmar Border.

University of Oxford2 sites in 1 country133 target enrollmentStarted: April 15, 2023Last updated: April 13, 2026

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Not Applicable
Status: Recruiting
Sponsor: University of Oxford
Enrollment: 133
Locations: 2
Primary Endpoint: Comparison of humoral and cellular responses to SARS-CoV-2 between bacteriologically confirmed TB patients under treatment vs healthy individuals.

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Detailed Description

In late 2020, COVID-19 pandemic was occurred globally. Like Tuberculosis (TB), severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection is primarily affected in respiratory tract with increased risk of severe clinical complications especially in particular risk population like diabetic patients and old ages. Like other viral infections, there is evidence that both acquired humoral and cellular immunological responses against the SARS-CoV-2 infection are key in providing protective immunity. Although the magnitude and durability of both binding and neutralizing antibodies after seroconversion of COVID-19 patients are highly variable at the individual patient level, higher level of neutralizing antibodies appears to be correlated with protection against reinfection.

As natural immunity alone after COVID-19 infection appears to be insufficient for protection against COVID-19, since the beginning of COVID-19 pandemic, several COVID-19 vaccines developed based on different technical platforms have been introduced globally. Up to August 2021, twenty COVID-19 vaccines has been included in WHO's Emergency Use Listing (EUL).

As protection against COVID-19 infection among TB patients is critical to prevent severe clinical outcomes, COVID-19 immunization program is carrying out among TB patients in the SMRU TB centers with supply of COVID-19 vaccines from Ministry of public health, Thailand. In Thailand, Pfizer-BioNTech COVID-19 vaccine, AstraZeneca vaccine and Janssen Ad26.COV2.S COVID-19 vaccine are widely available in COVID-19 vaccination campaigns.

Pfizer-BioNTech COVID-19 vaccine is an mRNA vaccine and its two-dose regimen with inter-dose interval of 21 days apart can provide effective protection against SARS-CoV-2- infection. Mild local and systemic reactions can occur after vaccination but serious adverse effects can be complicated rarely. It can also be provided for children over 6 months of age and reactogenicity is also less frequent.

AstraZeneca vaccine is a replication-deficient chimpanzee adenovirus-vectored vaccine expressing full-length SARS CoV-2 spike glycoprotein gene. Efficacy, immunogenicity and safety profiles of the vaccine are acceptable and reasonably well tolerated in healthy young and old adults, symptomatic COVID-19 patients and people with HIV infection.

Study Design

Study Type: Observational
Observational Model: Cohort
Time Perspective: Prospective

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: Yes

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).