Trial NCT04691908
Publication Khairullin B, EClinicalMedicine, 2022
Dates: 2020-12-25 to 2021-01-13
Funding: Public/non profit (Science Committee of the Ministry of Education and Science of the Republic of Kazakhstan. )
Conflict of interest: no COI
| Methods | |
| RCT | |
| Location :
Multicenter / Kazakhstan Follow-up duration (months): 6 | |
| QazCovid-in (n = 2400) Placebo (n = 600) |
|
| Inclusion criteria | Adults 18 years of age or older; healthy or with chronic concomitant diseases; informed consent. |
| Exclusion criteria | History of COVID-19 diagnosis; close contacts with persons suspected of being infected with SARS-CoV-2 or diagnosed with COVID- 19 in the last 14 days; presence of antibodies to SARS-CoV-2 in ELISA. |
| Interventions | |
| Intervention
2 IM doses of 5 mcg, 21 days apart |
|
| Control
2 IM doses of placebo, 21 days apart | |
| Participants | |
| Randomized 3000 participants | |
| Characteristics of participants Type of participants: Adults N=3000 1518 males Children: 0 Pregnant women: 0 Mean age: Age range: 18-79 | |
| Description of participants Healthy adults or those with chronic diseases, with no known or suspected history of COVID-19 at 3 centers in Kazakhstan | |
| Primary outcome | |
| In the register 1. Terms of seroconversion (the proportion of persons with a fourfold or higher change in antibody titers to SARS-CoV-2) [ Time Frame: at days 0, 21, 42, 90, 180 ] 2. To evaluate the immunogenicity of the QazCovid-in® vaccine inactivated against COVID-19 versus placebo [ Time Frame: at days 0, 21, 42, 90, 180 ] - The geometric mean titer of serum antibodies ELISA to SARS-CoV-2 after vaccination. The multiplicity of the change in the geometric mean titer of serum antibodies to SARS-CoV-2 after vaccination. 3. Frequency of confirmed cases of COVID-19 [ Time Frame: through study completion, an average of 6 months ] The presence of clinical manifestations and a positive laboratory test for SARS-CoV-2 virus RNA within 6 months after vaccination | |
| In the report Incidence of symptomatic COVID-19 infection cases manifested from day 14 after the first immunisation onwards and confirmed by the detection of SARS-CoV-2 nucleic acid in RT-PCR on a clinical sample. | |
| Variants description | |
| Variants | |
| Description Dominant variant: original Wuhan Hu-1-like viruses, direct evidence, Method: 45 samples were sequenced among the 74 cases, unclear if pre-planned or post hoc The regular monitoring of viruses circulated from March to July 2021 in Kazakhstan revealed that the Alpha (lineage B.1.1.7) variant of SARS-CoV-2 circulated in March along with the original SARS-CoV-2 virus,and later they were substituted by the Delta (lineage B.1.617.2.1.2) variant. The results of sequencing of viruses isolated from the study participants diagnosed with COVID-19 within the period from December 2020 to July 2021 showed that, alongside the original SARS- CoV-2 virus, Alpha (lineage B.1.1.7) and Delta (lineage B.1.617.2) variants induced the disease in vaccine recipi- ents with a similar frequency. | |
| Documents avalaible |
Protocol Yes. In English Statistical plan Yes 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 pre-print article and the registry were used in data extraction and assessment of risk of bias. The target sample size pre-specied in the protocol (n=3000) was achied in the trial (n=3000). There is no change from the trial registration in the intervention and control treatments.
This trial was updated on September 20th, 2022 after publication of the study report. |