Clinical trial NCT04871841: Study of Sputnik V COVID-19 Vaccination in Adults in Kazakhstan
Official title: Study of Sputnik V COVID-19 Vaccination in Adults in Kazakhstan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Vaccine Adverse Reaction
Keywords: Sputnik V
Gam-COVID-Vac
Vaccine safety
Vaccine reactogenicity
Vaccine immunogenicity
Lead sponsor: Karaganda Medical University
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2021-05-04
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited by invitation to volunteer at vaccination clinic sites.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants with Solicited Adverse Events (AEs) for 21 Days after First Vaccination
timeFrame: day 21
measure: Number of Participants with Solicited Adverse Events (AEs) for 42 Days after First Vaccination
timeFrame: day 42
measure: Change in the Titres of Systemic SARS-CoV-2 Binding Antibodies
timeFrame: Up to 6 months
Secondary outcomes:
measure: Change in the Titres of Mucosal SARS-CoV-2 Binding Antibodies
timeFrame: Up to 6 months
measure: Change in the Titres of Systemic SARS-CoV-2 Neutralizing Antibodies
timeFrame: Up to 6 months
measure: Change in the titres of Mucosal SARS-CoV-2 Neutralizing Antibodies
timeFrame: Up to 6 months
measure: Change in the concentration of systemic cytokines
timeFrame: Up to 6 months
measure: Difference in the study outcomes between participants with and without prior COVID-19 exposure.
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Karaganda
country: Kazakhstan
facility: Karaganda Medical University
Study officials:
affiliation: Research Centre, Karaganda Medical University
name: Irina Kadyrova, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University, Hamilton, Canada
name: Sergey Yegorov, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karaganda Medical University
name: Anar Turmukhambetova, MD/DMS
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.