Trial TCTR20211004001
Publication Intapiboon P, Vaccines, 2021
Funding: Public/non profit (The National Vaccine Institute and the Faculty of Medicine, Prince of Songkhla university, Thailand)
Conflict of interest: no COI
Methods | |
RCT | |
Location :
Single center / Thailand Follow-up duration (months): 1 | |
BNT162b2 low dose (0.06 mL) intradermal booster (n = 31)
BNT162b2 half dose (0.15 mL) intramuscular booster (n = 30) BNT162b2 standard dose (0.3 mL) intramuscular booster (n = 30) |
|
Inclusion criteria |
|
Exclusion criteria |
|
Interventions | |
Intervention
1 IM half (0.15 mL) dose of BNT162b2 1-3 months after 2-dose primary schedule of Sinovac 1 intradermal low (0.06 mL) dose of BNT162b2 1-3 months after 2-dose primary schedule of Sinovac |
|
Control
1 IM standard (0.3 mL) dose of BNT162b2 1-3 months after 2-dose primary schedule of Sinovac | |
Participants | |
Randomized 91 participants | |
Characteristics of participants Type of participants: Healthy adults N=91 40 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: NR | |
Description of participants Healthy adults who had reecived 2 doses CoronaVac with no current or known history of SARS-CoV-2 infection at a single center in Thailand | |
Primary outcome | |
In the register 1) binding antibodies against SARS-CoV-2 S protein by ELISA, Time point : on day 14, day 28 and month 3 after the booster vaccination; 2) neutralizing antibodies against SARS-CoV-2 RBD (delta variant) by competitive ELISA, Time point : on day 14, day 28 and month 3 after the booster dose | |
In the report anti-RBD-IgG | |
Documents available |
Protocol NR Statistical plan * Data-sharing stated:
Yes |
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 retrospective trial registry was used in data extraction and risk of bias assessment. Neither protocol nor statistical analysis plan were available at the time of data extraction. The article reports on only three of eight arms included in the registry. It is unclear whether any sample size was predefined for the reported arms. No outcome is identified as primary in the article, but the outcomes in the registry are reported. |