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| Name | Class |
|---|---|
| McMaster University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sputnik V Vaccinees | Participants (healthy adults aged >=18) will receive rAd26-S prime at day 0 and rAd5-S boost at day 21. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sputnik V | Biological | Participants will receive intramuscular (IM) injection of a single dose of rAd26-S and rAd5-S at day 0 and day 21, respectively. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be recruited by invitation to volunteer at vaccination clinic sites.
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| Name | Affiliation | Role |
|---|---|---|
| Irina Kadyrova, MD, PhD | Research Centre, Karaganda Medical University | Principal Investigator |
| Sergey Yegorov, PhD | McMaster University, Hamilton, Canada | Principal Investigator |
| Anar Turmukhambetova, MD/DMS | Karaganda Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karaganda Medical University | Karaganda | 100008 | Kazakhstan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33880458 | Background | 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. | |
| 35895743 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000718911 | Gam-COVID-Vac vaccine |
| C076225 | RAD5 protein, S cerevisiae |
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|
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 |
| Result |
| 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. |
| 35915123 | Result | 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |