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.
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing stated: Yes
Data accessibility: The Individual details of a participant are available upon request to BKh. Once the request is approved, the data can be transferred via a secure online platform. Correspondence to: Prof Berik Khairullin, khirullin@mail.ru
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.