Skip to main content
OpenTrials
Completed

NCT Number: NCT04871841

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Vaccine Adverse Reaction Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karaganda Medical University

Karaganda, 100008, Kazakhstan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sputnik V

Biological

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Change in the concentration of systemic cytokines

    Time frame: Up to 6 months

    The levels of cytokines measured in blood plasma.

  5. 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.

Sponsors and collaborators

Lead sponsor

Karaganda Medical University

Other

Collaborators

  • McMaster University

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
May 4, 2021
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.