Safety and Immunogenicity of Oxford AstraZeneca Vaccine in Zagazig University Hospital Health-care Workers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 246
- 试验地点
- 2
- 主要终点
- Seroconversion rate of neutralizing antibody
研究概览
简要总结
After SARS-COV-2 inactivated vaccine authorization for use in different countries including Egypt, investigating its immunogenicity, safety, and efficacy in preventing COVID-19 infection is highly needed. In Egypt, immunization of HCWs in isolation hospitals by SARS-COV-2 inactivated vaccine is now a national priority. Moreover, data and reports regarding the application of vaccine are still limited and deficient.
详细描述
This study will be conducted at Zagazig University hospital. Laboratory work will be implemented at Immunology Research Laboratory at Microbiology and Immunology Department, Faculty of Medicine, Zagazig University. A representative sample will be drawn from healthcare workers (HCWs) at Zagazig University Hospital. Assessment of inclusion and exclusion criteria by history taking. Blood samples will be drawn from HCWs by direct venipuncture before the start of immunization and 14 days after immunization. The incidence of any adverse reactions after each immunization will be recorded. SARS-CoV-2 neutralizing antibodies will be detected by enzyme-linked immunosorbent assay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Healthy healthcare workers
排除标准
- •Healthy healthcare workers' refusal.
- •Pregnancy and lactation.
- •Confirmed acute cases of SARS-CoV-2 Infection
- •Having a history of SARS-CoV-2 infection in the past 3 months.
- •Fever (body temperature > 37.0 ℃), dry cough, fatigue, nasal obstruction, runny nose, pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14 days before vaccination.
- •History of allergy to any vaccines
- •Previous vaccination within the last 30 days
结局指标
主要结局
Seroconversion rate of neutralizing antibody
时间窗: 84 days after each dose
Neutralizing antibody assay will be performed after each dose of the vaccine
Incidence of adverse reactions
时间窗: 7 days after each dose
Incidence of adverse reactions after each dose of the vaccine
次要结局
未报告次要终点
研究者
Noha M Hammad, MD
Principal investigator
Zagazig University