Trial TCTR20210923012
Publication Puthanakit T, Vaccine: X, 2022
Dates: 2021-10-17 to 2021-10-30
Funding: Public/non profit (National Vaccine Institute, Thailand; Chulalongkorn University; Vaccines used in this study were supported by the Department of Diseases Control, Ministry of Public Health, Thailand.)
Conflict of interest: no COI
Methods | |
RCT | |
Location :
Single center / Thailand Follow-up duration (months): 0.5 | |
BNT162b2 30 mcg (0.3mL) booster (n=17) BNT162b2 15 mcg (0.15mL) booster (n = 18) BNT162b2 10 mcg (0.1mL) booster (n = 17) |
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Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Intervention
1 IM dose of BNT162b2 15 mcg (0.15mL), 5 months after CoronaVac 3 mcg/BNT162b2 30 mcg or BNT162b2 20 mcg primary schedule 1 IM dose of BNT162b2 10 mcg (0.1mL), 5 months after CoronaVac 3 mcg/BNT162b2 30 mcg or BNT162b2 20 mcg primary schedule |
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Control
1 IM dose of BNT162b2 30 mcg (0.3mL), 5 months after CoronaVac 3 mcg/BNT162b2 30 mcg or BNT162b2 20 mcg primary schedule | |
Participants | |
Randomized 52 participants | |
Characteristics of participants Type of participants: Adolescents N=52 0 males Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: NR | |
Description of participants Healthy adolescents with no prior COVID-19 infection or vaccination at a single center in Thailand. | |
Primary outcome | |
In the register 1. Anti-S-RBD IgG Metric / Method of measurement : BIOTEC COVID-19 IgG ELISA Time point : Day 0, day 21/42, day 35/56, day 90/120, day 180, day 194, day 360; 2. Surrogate virus neutralization test (sVNT) to variants of concern e.g. Delta strain Metric / Method of measurement : ELISA Time point : Day 0, day 21/42, day 35/56, day 90/120, day 180, day 194, day 360; 3. T and B cell response Metric / Method of measurement : ELISpot Time point : Day 35/56, day 90/120, day 180; 4. Pseudovirus neutralizing antibody (pVNT) to Omicron strain Metric / Method of measurement : BIOTEC In-house assay Time point : Day 180, day 194, day 360 | |
In the report GMRs of sVNT against Delta variant and anti-S-RBD IgG-wild type at 14 days after primary vaccination series of each group using SV3w/PZ30 as the reference arm. | |
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 study registry and supplementary appendices were used in data extraction and risk of bias assessment. The protocol and statistical analysis plan were not available. The primary outcome in the article reflects that in the registry for the booster study. No target sample size was planned for the booster extension study. |