Trial TCTR20210731003
Publication Tawinprai K, Vaccine, 2022
Dates: 2021-08-09 to 2021-08-13
Funding: Public/non profit (Chulabhorn Royal Academy and National Vaccine Institute, Thailand)
Conflict of interest: no COI

Methods
RCT
Location : Single center / Thailand
Follow-up duration (months): 1
ChAdOx1 ID 0.1 mL boost (n = 41)
ChAdOx1 ID 0.2 mL boost (n = 43)
ChAdOx1 IM 0.5 mL boost (n = 41)
Inclusion criteria
  • Age 18 years or older
  • prior two-dose Coronavac vaccination completed at least 2 months previously.
Exclusion criteria
  • Pregnancy
  • lactation
  • concurrent active underlying disease, receipt of any vaccine within 14 days of enrolment, and fever or respiratory tract infection within 14 days of enrolment.
Interventions
Intervention
1 intradermal dose of 0.1 mL ChAdOx1-S, at least 2 months after primary CoronaVac schedule
2 simultaneous intradermal doses of 0.1 mL ChAdOx1-S, at least 2 months after primary CoronaVac schedule
Control
1 IM dose of 0.5 mL ChAdOx1-S, at least 2 months after primary CoronaVac schedule
Participants
Randomized
125 participants
Characteristics of participants
Type of participants: Adults
N=125
121 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range:
Description of participants
Adults who had received a 2-dose primary Coronavac schedule at least 2 months previously at a single center in Thailand.
Primary outcome
In the register
Humoral immunity 2 weeks after third dose (Double antigen technique for detection of Antibody level of total antibody of spike protein of SARS-CoV-2)
In the report
GMR of anti-RBD antibodies of participants in the ID1 and ID2 groups compared with that of those in the IM group 2 weeks after vaccination
Documents
available

Protocol

NR

Statistical plan

*

Data-sharing stated: No
Data accessibility: Corresponding author at: Kriangkrai Tawinprai, E-mail address: Kriangkrai.taw@cra.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 was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The primary outcome in the article reflects that in the registry. The trial (n = 125) achieved its target sample size (n = 120).