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.
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.
Study Type
OBSERVATIONAL
Enrollment
82
Participants will receive intramuscular (IM) injection of a single dose of rAd26-S and rAd5-S at day 0 and day 21, respectively.
Karaganda Medical University
Karaganda, Kazakhstan
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 6 months
Change in the Titres of Mucosal SARS-CoV-2 Binding Antibodies
The titres of SARS-CoV-2 binding antibodies measured in mucosal (nasal) swabs.
Time frame: 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.
Time frame: 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.
Time frame: Up to 6 months
Change in the concentration of systemic cytokines
The levels of cytokines measured in blood plasma.
Time frame: 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.
Time frame: Up to 6 months
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