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Covid19NCT04871841

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

An observational study of Covid19 and Vaccine Adverse Reaction, run by Karaganda Medical University at 1 site in Kazakhstan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Covid19, Vaccine Adverse Reaction
What is being tested?
Sputnik V
Type of treatment
Injection or infusion
How many people
82 participants
Where
1 siteKazakhstan
Study dates
5 Apr 2021to 20 Jun 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Kazakhstan1 site

  • Karaganda Medical University

    Karaganda, 100008

Other trials in Kazakhstan

About this study

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.

Read the 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.

Being tested
Sputnik V
Keywords
Sputnik V, Gam-COVID-Vac, Vaccine safety, Vaccine reactogenicity, Vaccine immunogenicity
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sputnik VBiological

    Also called rAd26-S, rAd5-S, Gam-COVID-Vac

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

Study groups in NCT04871841
Study groupRoleWhat they receive
Sputnik V VaccineesParticipants (healthy adults aged >=18) will receive rAd26-S prime at day 0 and rAd5-S boost at day 21.
Receives: Biological: Sputnik V

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: day 21

  2. 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.

    Measured: day 42

  3. Change in the Titres of Systemic SARS-CoV-2 Binding Antibodies

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

    Measured: Up to 6 months

Secondary outcomes (5)

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

    The titres of SARS-CoV-2 binding antibodies measured in mucosal (nasal) swabs.

    Measured: Up to 6 months

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

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

    Measured: Up to 6 months

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

    The titres of SARS-CoV-2 neutralizing antibodies measured in mucosal (nasal) swabs.

    Measured: Up to 6 months

  4. Change in the concentration of systemic cytokines

    The levels of cytokines measured in blood plasma.

    Measured: Up to 6 months

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

    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.

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2021
  2. Study start5 Apr 2021
  3. Primary completion5 Sep 2021
  4. Study completion20 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04871841
Sponsor's protocol ID
128/36-21-23
Status last verified
Apr 2024
First submitted
1 May 2021
Last updated
12 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 33880458

  • 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.

    PubMed 35895743

  • 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.

    PubMed 35915123

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19 and Vaccine Adverse Reaction, run by Karaganda Medical University at 1 site in Kazakhstan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Solicited Adverse Events (AEs) for 21 Days after First Vaccination (time frame: day 21). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04871841, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.

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