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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Covid19, Vaccine Adverse Reaction

Intervention / Treatment
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* Biological: Sputnik V


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sputnik V Vaccinees<br>Participants (healthy adults aged >=18) will receive rAd26-S prime at day 0 and rAd5-S boost at day 21. | Biological: Sputnik V<br>* Participants will receive intramuscular (IM) injection of a single dose of rAd26-S and rAd5-S at day 0 and day 21, respectively.<br>* Other names: Gam-COVID-Vac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Change in the concentration of systemic cytokines | The levels of cytokines measured in blood plasma. | Up to 6 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sputnik V, Gam-COVID-Vac, Vaccine safety, Vaccine reactogenicity, Vaccine immunogenicity