CompletedNot Applicable

Study of Sputnik V COVID-19 Vaccination in Adults in Kazakhstan

Kazakhstan82 participantsStarted 2021-04-05

Plain-language summary

This study will assess the safety, reactogenicity, and immunogenicity of Gam-COVID-Vac (Sputnik V) vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing coronavirus disease 2019 (COVID-19). The vaccine contains two recombinant adenoviral vectors harbouring SARS-CoV-2 Spike gene. The vaccine will be administered intramuscularly on a 2-dose prime-boost schedule. Participants will be healthy adults aged greater than or equal to 18 years, voluntarily undergoing vaccination according to the guidelines of the Ministry of Healthcare of Kazakhstan.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Participant must be healthy (in the physician's clinical judgment and as confirmed by medical records, and physical examination at screening). * Willing to give informed consent, and answer short questionnaires on past exposure to COVID-19 and post-vaccination reactogenicity. * Willing to comply with the requirements of the protocol. Exclusion Criteria: * Participant shows signs of an acute illness (excluding minor illnesses such as diarrhea or mild upper respiratory tract infection). * Participant has a positive laboratory-confirmed test result for SARS-CoV-2 infection at screening. * Deemed by investigators to be unlikely to complete study protocol.

What they're measuring

Number of Participants with Solicited Adverse Events (AEs) for 21 Days after First Vaccination

Timeframe: day 21

Number of Participants with Solicited Adverse Events (AEs) for 42 Days after First Vaccination

Timeframe: day 42

Change in the Titres of Systemic SARS-CoV-2 Binding Antibodies

Timeframe: Up to 6 months

Trial details

NCT IDNCT04871841

SponsorKaraganda Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-09-05

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