Trial TCTR20220112002
Publication Assantachai P, J Infect Dis, 2023

Funding: Public/non profit (Health Systems Research Institute)
Conflict of interest: no COI

Methods
RCT
Location : Single center / Thailand
Follow-up duration (months): 1
mRNA-1273 ID (n=35)
mRNA-1273 IM (n=35)
BNT162b2 ID (n=70)
BNT162b2 IM (n=70)
Inclusion criteria
  • Individuals aged ≥65 years who have primarily received 2 doses of IM ChAdOx1 series 12–24 weeks earlier
Exclusion criteria
  • Any previous infections of SARS-CoV-2
  • acute illness or inflammation, history of anaphylaxis to any vaccination or drugs
  • receipt of any vaccination within 2 previous weeks
  • and receipt of any immu- nosuppressants or in the state of immunosuppression
Interventions
Intervention
1 dose of mRNA-127 20 mcg ID, 12-24 weeks after 2 doses of ChAdOx1
1 dose of BNT162b 10 mcg ID, 12-24 weeks after 2 doses of ChAdOx1
Control
1 dose of mRNA-127, 12-24 weeks after 2 doses of ChAdOx1 1 dose of BNT162b, 12-24 weeks after 2 doses of ChAdOx1
Participants
Randomized
210 participants
Characteristics of participants
Type of participants: Adults
N=210
62 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range: NR
Description of participants
Adults 65 years of age or older in a single centre in Thailand
Primary outcome
In the register
vaccine adverse event: number of adverse event at 7 days
In the report
Humoral inmunogenicity
Documents
available

Protocol

NR

Statistical plan

*

Data-sharing stated: Yes
Data accessibility: All data produced in the present study are available upon reasonable request to the authors (preprint)
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 supplementary materials, and study registrywere used in data extraction and risk of bias assessment. Protocol was not available and registry was retrospective. The target sample size (210) was achieved. This trial compared different routes of administration for the same vaccine.There were important differences between registry and published report in interventions and outcomes.