Trial TCTR20211102003
Publication Bruminhent J, Am J Transplant, 2022
Dates: 2021-11-22 to 2022-01-16
Funding: Public/non profit (National Research Council of Thailand (NRCT); Ministry of Higher Education, Science, Research, and Innovation of Thailand.)
Conflict of interest: no COI

Methods
RCT
Location : Single center / Thailand
Follow-up duration (months): 0.5
1 dose BNT162b2 or mRNA-1273 (n=43) 1 dose ChAdOx1 nCoV-19 (n=42)
Inclusion criteria
  • Adults aged ≥18 years old
  • Stable kidney allograft function on an immunosuppressive regimen
  • At least 30 days post-transplant
  • Receipt of a primary series two doses of CoronaVac (CVIM 1 3–5 weeks apart) or
  • Followed by one dose of ChAdOx1 nCoV-19 vaccine (CVIM 2 11–13 weeks after) or
  • Primary series two doses of ChAdOx1 nCoV-19 vaccine (CVIM 3 11–13 weeks apart).
Exclusion criteria
  • Suspected of having a respiratory tract infection or any concurrent infection
  • Receiving intense immunosuppressants for kidney allograft rejection
  • Had a previous COVID-19 history.
Interventions
Intervention
1 IM dose of BNT162b2 or mRNA-1273 after 2 doses of CoronaVac (3–5 weeks apart) (some followed by 1 dose of ChAdOx1) or 2 doses of ChAdOx1
Control
1 IM dose of ChAdOx1 after 2 doses of CoronaVac (3–5 weeks apart) (some followed by 1 dose of ChAdOx1) or 2 doses of ChAdOx1
Participants
Randomized
85 participants
Characteristics of participants
Type of participants: Kidney transplant recipients
N=85
47 males
Children: 0
Immunocompromized patients: 77
Mean age:
Age range: NR
Description of participants
Adult kidney transplant recipients without a history of COVID-19 in a single centre in Thailand.
Primary outcome
In the register
Outcome Name: Immunogenicity; Metric / Method of measurement: Check Humoral and cell-mediated immunity prior to additional dose of vaccine and 2 weeks after; Time point: Week 0 and week 2
In the report
Seroconversion rate of the anti-SARS-CoV-2 RBD IgG antibody levels at 2 weeks after an additional dose of each COVID-19 vaccine.
Documents
available

Protocol

NR

Statistical plan

*

Data-sharing stated: Yes
Data accessibility: Sasisopin Kiertiburanakul, sasisopin.kie@mahidol.ac.th
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to the published article, the prospective registry and supplemental material were used in data extraction and risk of bias assessment. The protocol and statistical analysis plan were not available. There is no change from the trial registration in the intervention and control treatments. The target sample size (n=120) specified in the registry was not achieved (n=85). On January 23rd, 2023 this trial was updated to incluude the link to the abstract of the 2022 American Transplant Congress.