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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04871841
• Other study ID #: 128/36-21-23
• Status: Completed
• Start date: April 5, 2021
• Est. completion date: June 20, 2023

Study information

• Verified date: April 2024
• Source: Karaganda Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 20, 2023
• Est. primary completion date: September 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Vaccine Adverse Reaction

Intervention

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.

Locations

Country	Name	City	State
Kazakhstan	Karaganda Medical University	Karaganda

Sponsors (2)

Lead Sponsor	Collaborator
Karaganda Medical University	McMaster University

Country where clinical trial is conducted

Kazakhstan, 

References & Publications (3)

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 K — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Change in the Titres of Mucosal SARS-CoV-2 Binding Antibodies	The titres of SARS-CoV-2 binding antibodies measured in mucosal (nasal) swabs.	Up to 6 months
Secondary	Change in the Titres of Systemic SARS-CoV-2 Neutralizing Antibodies	The titres of SARS-CoV-2 neutralizing antibodies measured in serum/plasma.	Up to 6 months
Secondary	Change in the titres of Mucosal SARS-CoV-2 Neutralizing Antibodies	The titres of SARS-CoV-2 neutralizing antibodies measured in mucosal (nasal) swabs.	Up to 6 months
Secondary	Change in the concentration of systemic cytokines	The levels of cytokines measured in blood plasma.	Up to 6 months
Secondary	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.	Up to 6 months