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

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ClinicalTrials.gov Identifier: NCT04871841
Recruitment Status : Recruiting
First Posted : May 4, 2021
Last Update Posted : May 4, 2021
Sponsor:
Collaborator:
McMaster University
Information provided by (Responsible Party):
Karaganda Medical University

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.

Condition or disease Intervention/treatment
Covid19 Vaccine Adverse Reaction Biological: Sputnik V

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.

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of Sputnik V COVID-19 Vaccination in Adults in Kazakhstan
Actual Study Start Date : April 5, 2021
Estimated Primary Completion Date : August 5, 2021
Estimated Study Completion Date : December 5, 2021

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited by invitation to volunteer at vaccination clinic sites.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04871841


Contacts
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Contact: Irina Kadyrova, MD, PhD +77015033730 ikadyrova@qmu.kz
Contact: Dmitriy Babenko, MD, PhD dmitriy.b.babenko@gmail.com

Locations
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Kazakhstan
Karaganda Medical University Recruiting
Karaganda, Kazakhstan, 100008
Contact: Irina Kadyrova, MD, PhD    +77015033730      
Sub-Investigator: Yevgeniya Kolesnikova, MD, PhD         
Sub-Investigator: Svetlana Kolesnichenko, MD         
Sub-Investigator: Ilya Korshukov, MD         
Sponsors and Collaborators
Karaganda Medical University
McMaster University
Investigators
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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/Doctor of medical science Karaganda Medical University
Publications:

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Responsible Party: Karaganda Medical University
ClinicalTrials.gov Identifier: NCT04871841    
Other Study ID Numbers: 128/36-21-23
First Posted: May 4, 2021    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karaganda Medical University:
Sputnik V
Gam-COVID-Vac
Vaccine safety
Vaccine reactogenicity
Vaccine immunogenicity