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

April 11, 2024 updated by: Karaganda Medical University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kazakhstan
      • Karaganda, Kazakhstan, 100008
        • Karaganda Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited by invitation to volunteer at vaccination clinic sites.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sputnik V Vaccinees
Participants (healthy adults aged >=18) will receive rAd26-S prime at day 0 and rAd5-S boost at day 21.
Biological: 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.
Other Names:
  • rAd26-S
  • rAd5-S
  • Gam-COVID-Vac

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Solicited Adverse Events (AEs) for 21 Days after First Vaccination
Time Frame: day 21
Solicited AEs are pre-defined local (at the injection site) and systemic adverse events, for which participants are questioned. Solicited local AEs include injection site pain, redness, swelling, itching. Solicited systemic AEs include fatigue, headache, myalgia, chills, fever, joint pain, nausea, vomiting, diarrhea, abdominal pain, rash external to injection site.
day 21
Number of Participants with Solicited Adverse Events (AEs) for 42 Days after First Vaccination
Time Frame: day 42
Solicited AEs are pre-defined local (at the injection site) and systemic adverse events for which participants are questioned. Solicited local AEs include injection site pain, redness, swelling, itching. Solicited systemic AEs include fatigue, headache, myalgia, chills, fever, joint pain, nausea, vomiting, diarrhea, abdominal pain, rash external to injection site.
day 42
Change in the Titres of Systemic SARS-CoV-2 Binding Antibodies
Time Frame: Up to 6 months
The titres of SARS-CoV-2 binding antibodies measured in serum/plasma.
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Titres of Mucosal SARS-CoV-2 Binding Antibodies
Time Frame: Up to 6 months
The titres of SARS-CoV-2 binding antibodies measured in mucosal (nasal) swabs.
Up to 6 months
Change in the Titres of Systemic SARS-CoV-2 Neutralizing Antibodies
Time Frame: Up to 6 months
The titres of SARS-CoV-2 neutralizing antibodies measured in serum/plasma.
Up to 6 months
Change in the titres of Mucosal SARS-CoV-2 Neutralizing Antibodies
Time Frame: Up to 6 months
The titres of SARS-CoV-2 neutralizing antibodies measured in mucosal (nasal) swabs.
Up to 6 months
Change in the concentration of systemic cytokines
Time Frame: Up to 6 months
The levels of cytokines measured in blood plasma.
Up to 6 months
Difference in the study outcomes between participants with and without prior COVID-19 exposure.
Time Frame: Up to 6 months
The reactogenicity and immunogenicity readouts will be compared between participants with and without prior COVID-19 exposure, as defined by the presence of SARS-CoV-2-reactive antibodies prior to vaccination.
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karaganda Medical University

Collaborators

McMaster University

Investigators

  • Principal Investigator: Irina Kadyrova, MD, PhD, Research Centre, Karaganda Medical University
  • Principal Investigator: Sergey Yegorov, PhD, McMaster University, Hamilton, Canada
  • Study Chair: Anar Turmukhambetova, MD/DMS, Karaganda Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2021

Primary Completion (Actual)

September 5, 2021

Study Completion (Actual)

June 20, 2023

Study Registration Dates

First Submitted

May 1, 2021

First Submitted That Met QC Criteria

May 1, 2021

First Posted (Actual)

May 4, 2021

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 128/36-21-23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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