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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-05

Study Completion Date

2023-06-20

Brief Summary

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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.

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Detailed Description

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Sputnik V (Gam-COVID-Vac) is an adenoviral vector vaccine developed by The Gamaleya Research Institute of Epidemiology and Microbiology (Moscow, Russia), registered and approved by the Ministry of Healthcare of Kazakhstan. The vaccine incorporates two recombinant adenoviral (rAd) vectors, rAd5 and rAd26, harbouring SARS-CoV-2 Spike (S) gene.

Earlier Phase I/II clinical trials established that Sputnik V is safe and efficacious when given intramuscularly in two sequential doses, as a rAd26-S prime at day 0 followed by rAd5-S boost at day 21, at 1x10\^11 particles per dose. The aim of the current study is to provide data on the safety, reactogenicity, and immunogenicity of Sputnik V in adults vaccinated in Kazakhstan using the established vaccination regimen. In addition, the effects of prior COVID-19 exposure on the vaccine safety, reactogenicity, and immunogenicity will be assessed.

Conditions

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Covid19 Vaccine Adverse Reaction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Sputnik V Vaccinees

Participants (healthy adults aged \>=18) will receive rAd26-S prime at day 0 and rAd5-S boost at day 21.

Sputnik V

Intervention Type BIOLOGICAL

Participants will receive intramuscular (IM) injection of a single dose of rAd26-S and rAd5-S at day 0 and day 21, respectively.

Interventions

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Sputnik V

Participants will receive intramuscular (IM) injection of a single dose of rAd26-S and rAd5-S at day 0 and day 21, respectively.

Intervention Type BIOLOGICAL

Other Intervention Names

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rAd26-S rAd5-S Gam-COVID-Vac

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes