Trial NCT04523571 ; ChiCTR
Publication Zhu F, ResearchSquare, 2021
Dates: 18/07/2021 to 14/08/2021
Funding: Private (BioNTech RNA Pharmaceuticals GmbH, and Shanghai Fosun Pharmaceutical Development, Inc.)
Conflict of interest: Yes
Methods | |
RCT | |
Location :
Single center / China Follow-up duration (months): 1.6 | |
•10 mcg BNT126b1 (n= 48)
•30 mcg BNT126b1 (n= 48) •Placebo (n= 48) |
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Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Intervention
2 IM doses of 10mcg BNT126b1 per dose, 21 days apart 2 IM doses of 30 mcg BNT126b1 per dose, 21 days apart |
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Control
2 IM doses of saline, 21 days apart | |
Participants | |
Randomized 144 participants | |
Characteristics of participants Type of participants: Healthy volunteers N=144 72 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 18-85 | |
Description of participants Healthy SARS-CoV-2 infection-free adults aged 18-55 and 65-85 at a single center in China | |
Primary outcome | |
In the register 1. Occurrence of solicited local reactions in the subjects (e.g., vaccination sites: pain/tenderness, erythema/redness, induration/swelling) during the 14-days after each dose of BNT162b1 or placebo. [ Time Frame: 14 days following each dose administration ]; 2. Occurrence of solicited systematic reactions (e.g., nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) during 14-day after each dose of BNT162b1 or placebo. [ Time Frame: 14 days following each dose administration ]; 3. Occurrence of adverse event (AE) associated with vaccination in subjects during the 21-day period after prime vaccination of BNT162b1 or placebo. [ Time Frame: 21-day period after prime vaccination ]; 4. Occurrence of AE associated with vaccination in subjects during the 28-day period after boost dose of BNT162b1 or placebo. [ Time Frame: 28-day period after boost dose ] | |
In the report The primary endpoints for safety evaluation were the incidence of solicited local reactions at the injection site or systemic adverse reactions within 14 days post-vaccination, and adverse events following the full immunization until 28 days after receiving the boost dose. | |
Documents available |
Protocol Yes. In Statistical plan
Data-sharing stated:
Yes, available beginning 3 months and ending 1 year after publication |
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 |
Low |
General comment | In addition to the pre-print article, the trial registries were used in data extraction and assessment of risk of bias. The protocol referred to in the pre-print was not accessible at the time of data extraction. This was an interim analysis of a phase 1 trial. Recruitment is completed and planned sample size has been reached, however, the study is still ongoing for longer term follow-up for some of the outcomes. There were no substantive differences between the pre-print article and the trial registries in population, procedures, interventions or outcomes. |