Health TrialsbyHealthPanel

Immunogenicity of COVID-19 Vaccines in Tuberculosis Patients

ConditionsCovid-19 PandemicsTuberculosis
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

This trial accepts healthy volunteers

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 population

TB cohort - Bacteriologically confirmed TB patients (54 in cohort of patients) Comparator- Clinically healthy individuals (54 in healthy comparator)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Pfizer-BioNTech COVID-19 vaccine

    Biological/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)

  • AstraZeneca vaccine

    Biological/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)

  • Janssen Ad26.COV2.S COVID-19 vaccine

    Biological/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)

Treatment groups

133 Participants
are divided into 2 treatment groups
Group A: TB cohort3 interventions
Group B: Healthy comparator3 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Day 49 in Pfizer-BioNTech COVID-19 vaccine, Day 112 in AstraZeneca vaccine or Day 56 in Janssen Ad26.COV2.S COVID-19 vaccine
2

Comparison of humoral and cellular responses to SARS-CoV-2 between bacteriologically confirmed TB patients under treatment vs healthy individuals.

Time frame
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

1

Occurrence and comparison of solicited local reactogenicity signs and symptoms for 7 days following each dose of vaccination

Time frame
7 Days
2

Occurrence and comparison of solicited systemic reactogenicity signs and symptoms for 7 days following each dose of vaccination

Time frame
7 Days
3

Occurrence and comparison of unsolicited adverse events (AEs) following each dose of vaccination

Day 0, 7 days following first dose of vaccination, Day 21, 7 days following second dose of vaccination, Day 49 in Pfizer-BioNTech COVID-19 Vaccine, Day 0, 7 days following first dose of vaccination, Day 84, 7 days following second dose of vaccination, Day 112 in AstraZeneca vaccine or Day 0, 7 days following single dose of vaccination, Day 28 and Day 56 in Janssen Ad26.COV2.S COVID-19 vaccine

Time frame
Day 0, Day 7, Day 21, Day 28, Day 49, Day 56, Day 84, Day 112 in each vaccination
4

Comparison of changes from baseline for safety laboratory measures between bacteriologically confirmed TB patients under treatment vs healthy individuals.

Comparison of changes from baseline for safety laboratory measures between bacteriologically confirmed TB patients under treatment vs healthy individuals at the day of second dose vaccination in double dose scheduled COVID-19 vaccine or 28 days following single dose of vaccine and the final day of study.

Time frame
Day 0, Day 21, Day 28, Day 84

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oxford

Lead sponsor

Source ClinicalTrials.gov
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