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

NCT04871841 | Completed

• 1 other identifier: 128/36-21-23
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19; Vaccine Adverse Reaction

Keywords

Sputnik V; Gam-COVID-Vac; Vaccine safety; Vaccine reactogenicity; Vaccine immunogenicity

Outcome Measures

Primary Outcomes (3)

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

  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

  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

  The titres of SARS-CoV-2 binding antibodies measured in serum/plasma.

  Up to 6 months

Secondary Outcomes (5)

• Change in the Titres of Mucosal SARS-CoV-2 Binding Antibodies

  Up to 6 months

• Change in the Titres of Systemic SARS-CoV-2 Neutralizing Antibodies

  Up to 6 months

• Change in the titres of Mucosal SARS-CoV-2 Neutralizing Antibodies

  Up to 6 months

• Change in the concentration of systemic cytokines

  Up to 6 months

• Difference in the study outcomes between participants with and without prior COVID-19 exposure.

  Up to 6 months

Study Arms (1)

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

Interventions

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.

Also known as: rAd26-S, rAd5-S, Gam-COVID-Vac

Sputnik V Vaccinees

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karaganda Medical University: lead
• McMaster University: collaborator

Study Sites (1)

Karaganda Medical University

Karaganda, 100008, Kazakhstan

Location

Related Publications (3)

• Yegorov S, Goremykina M, Ivanova R, Good SV, Babenko D, Shevtsov A, MacDonald KS, Zhunussov Y; COVID-19 Genomics Research Groupon behalf of the Semey COVID-19 Epidemiology Research Group. Epidemiology, clinical characteristics, and virologic features of COVID-19 patients in Kazakhstan: A nation-wide retrospective cohort study. Lancet Reg Health Eur. 2021 May;4:100096. doi: 10.1016/j.lanepe.2021.100096. Epub 2021 Apr 16.

  PMID: 33880458 BACKGROUND

• Kadyrova I, Yegorov S, Negmetzhanov B, Kolesnikova Y, Kolesnichenko S, Korshukov I, Akhmaltdinova L, Vazenmiller D, Stupina Y, Kabildina N, Ashimova A, Raimbekova A, Turmukhambetova A, Miller MS, Hortelano G, Babenko D. High SARS-CoV-2 seroprevalence in Karaganda, Kazakhstan before the launch of COVID-19 vaccination. PLoS One. 2022 Jul 27;17(7):e0272008. doi: 10.1371/journal.pone.0272008. eCollection 2022.

  PMID: 35895743 RESULT

• Yegorov S, Kadyrova I, Negmetzhanov B, Kolesnikova Y, Kolesnichenko S, Korshukov I, Baiken Y, Matkarimov B, Miller MS, Hortelano GH, Babenko D. Sputnik-V reactogenicity and immunogenicity in the blood and mucosa: a prospective cohort study. Sci Rep. 2022 Aug 1;12(1):13207. doi: 10.1038/s41598-022-17514-3.

  PMID: 35915123 RESULT

MeSH Terms

Conditions

COVID-19

Interventions

Gam-COVID-Vac vaccine; RAD5 protein, S cerevisiae

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Irina Kadyrova, MD, PhD

  Research Centre, Karaganda Medical University

  PRINCIPAL INVESTIGATOR

• Sergey Yegorov, PhD

  McMaster University, Hamilton, Canada

  PRINCIPAL INVESTIGATOR

• Anar Turmukhambetova, MD/DMS

  Karaganda Medical University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2021
• First Posted: May 4, 2021
• Study Start: April 5, 2021
• Primary Completion: September 5, 2021
• Study Completion: June 20, 2023
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

KA (1)