Trial NCT04530357
Publication Zakarya K , EClinicalMedicine, 2021
Dates: 2020-10-15 to 2020-10-20
Funding: Public/non profit (Science Committee of the Ministry of Education and Science of the Republic of Kazakhstan)
Conflict of interest: Yes
Methods | |
RCT | |
Location :
Single center / Kazakhstan Follow-up duration (months): 6 | |
QazCovid-in D1/D21 (n=100) QazCovid-in D1 (n=100) | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Intervention
2 IM doses of 5 mcg, 21 days apart |
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Control
1 IM dose of 5 mcg | |
Participants | |
Randomized 200 participants | |
Characteristics of participants Type of participants: Healthy adults N=200 77 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 20-66 | |
Description of participants Healthy adults with no history of COVID-19 that tested negative for SARS-CoV-2 and HIV virus at a single centre in Kazakhstan. | |
Primary outcome | |
In the register 1) Frequency of adverse events up to seven days after immunization [ Time Frame: Seven days after each immunization ]; 2) Frequency of adverse events up to 21 days after immunization [ Time Frame: 21 days after each immunization ]; 3) The proportion of volunteers with increased levels of the immune response of specific neutralizing antibody titers in ELISA following the vaccination, compared with a placebo [ Time Frame: at days 0, 21, 27, 42 ]; 4) Changing of virus-neutralizing antibodies to SARS-CoV-2 virus in blood serum samples [ Time Frame: at days 0, 21, 27, 42 ] | |
In the report 1) solicited adverse reactions within 7 days after each dose; 2) unsolicited adverse events (AEs) for 21 days after each vaccination; 3) geometric mean titres (GMTs) of S-specific antibodies measured on days 21 and 42 after vaccination; 4) GMTs of virus neutralizing antibodies measured on days 21 and 42 after vaccination | |
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 prospective trial registry and supplementary materials were used in data extraction and risk of bias assessment. Neither protocol or statistical analysis plan was available. The fourth primary outcome (Changing of virus-neutralizing antibodies to SARS-CoV-2 virus in blood serum samples) was added to the registry near the end of the phase 1 and phase 2 studies. There were no other differences between trial registry and the published report in population, procedures, interventions or outcomes. The trial achieved its pre-specified sample size. |