Trial ChiCTR2000034825 ; NCT04523571
Publication Li J, Nature Medicine, 2021
Dates: 2020-07-28 to 2020-08-14
Funding: Private (BioNTech RNA Pharmaceuticals and Shanghai Fosun Pharmaceutical Development.)
Conflict of interest: Yes
| Methods | |
| RCT | |
| Location :
Single center / China Follow-up duration (months): 1.6 | |
| Low-dose BNT162b1 (n = 48
High-dose BNT162b1 (n = 48) Placebo (n = 48) |
|
| Inclusion criteria | Healthy young adults between 18 and 55 years of age, and older adults between 65 and 85; good health as established by medical history, physical examination, and laboratory tests at the screening visit; both male and female participants agreed to use contraception during the trial. Healthy young adults between 18 and 55 years of age, and older adults between 65 and 85; good health as established by medical history, physical examination, and laboratory tests at the screening visit; both male and female participants agreed to use contraception during the trial. |
| Exclusion criteria | Pregnant or breastfeeding ; tested positive for SARS-CoV-2 via a commercial rapid diagnostic kit for IgM or IgG antibody to SARS-CoV-2 (Livzon diagnostics) or via testing with a pharyngeal swab nucleic acid diagnostic test (Fosun Pharma) ; presence of features of COVID-19 on chest computed tomography ; serious cardiovascular disease or chronic conditions such as uncontrolled diabetes and hypertension, AIDS, hepatitis B and hepatitis C. |
| Interventions | |
| Intervention
2 IM doses of 10 mcg BNT162b1, 21 days apart 2 IM doses of 30 mcg BNT162b1, 21 days apart |
|
| Control
2 IM doses of 0.9% NaCl, 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: NR | |
| Description of participants Healthy young adults between 18 and 55 years of age, and older adults between 65 and 85 that were SARS-COVID-2 infection-free at a single center in China. | |
| Primary outcome | |
| In the register Occurrence of solicited local reactions in the subjects ; Occurrence of solicited systematic reactions [ Time Frame: 14 days following each dose administration ]; 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 ] 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 the safety evaluation were the incidence of solicited local reactions at the injection site or systemic adverse reactions in the 14 d after the prime or boost dose, and adverse events after the full immunization in the 28 d after receiving the boost dose. | |
| Variants description | |
| Variants | |
| Description | |
| Documents avalaible |
Protocol Yes. In English Statistical plan Yes Data-sharing stated:
Yes, For 1 year after the publication of this article |
| 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 published article, the trial registry, protocol, statistical analysis plan (in protocol) and supplementary materials were used in data extraction and assessment of risk of bias. There were no substantive differences between the trial registry, protocol and statistical analysis plan and the published article in population, procedures, interventions or outcomes. The study achieved its pre-defined target sample size. |