Study of Sputnik V COVID-19 Vaccination in Adults in Kazakhstan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Number of Participants with Solicited Adverse Events (AEs) for 42 Days after First Vaccination
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Number of Participants with Solicited Adverse Events (AEs) for 42 Days after First Vaccination
时间窗: day 42
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.
Number of Participants with Solicited Adverse Events (AEs) for 21 Days after First Vaccination
时间窗: day 21
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.
Change in the Titres of Systemic SARS-CoV-2 Binding Antibodies
时间窗: Up to 6 months
The titres of SARS-CoV-2 binding antibodies measured in serum/plasma.
次要结局
- Change in the Titres of Mucosal SARS-CoV-2 Binding Antibodies(Up to 6 months)
- Change in the Titres of Systemic SARS-CoV-2 Neutralizing Antibodies(Up to 6 months)
- Change in the concentration of systemic cytokines(Up to 6 months)
- Change in the titres of Mucosal SARS-CoV-2 Neutralizing Antibodies(Up to 6 months)
- Difference in the study outcomes between participants with and without prior COVID-19 exposure.(Up to 6 months)