Trial NCT05142319
Publication Poh XY, Clin. Infect. Dis., 2022
Dates: 2021-10-01 to 2021-11-30
Funding: Public/non profit (Singapore National Medical Research Council; US Food and Drug Administration Medical Countermeasures Initiative; Medical Research Council (UK))
Conflict of interest: Yes
Methods | |
RCT | |
Location :
Single center / Singapore Follow-up duration (months): 1 | |
BNT162b2/boost BNT162b2 (n = 51) BNT162b2/boost mRNA-1273 (n = 49) |
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Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Intervention
1 IM dose of 50 mcg mRNA-1273 at least 6 months after primary BNT162b2 schedule |
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Control
1 IM dose of 30 mcg BNT162b2 at least 6 months after primary BNT162b2 schedule | |
Participants | |
Randomized 100 participants | |
Characteristics of participants Type of participants: Adults N=100 43 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 23-84 | |
Description of participants Adults at a single center in Singapore with no previous history of COVID-19 who had received a primary series of BTN162b2 at least 6 months previously | |
Primary outcome | |
In the register SARS-CoV-2 anti-spike immunoglobulins [ Time Frame: Day 28 ] To determine the presence and levels of anti-SARS-COV-2 in human sera | |
In the report Whether a heterologous mRNA-1273 COVID-19 vaccine booster leads to non-inferior humoral immunity against wild-type SARSCoV-2 and/or VOCs at day 28 compared with homologous BTN162b2 | |
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 pre-print article, the trial registry and supplementary appendices were used in data extraction and assessment of risk of bias. At the time of extraction neither protocol nor statistical analysis plan was available. The trial (n = 100) did not achieve its target sample size (n = 174). The article presented a prelimary analyses (with recuitment complete) for a study with ongoing follow-up. This trial was updated on June 17th, 2022 after publication of study report. |