Safety, immunogenicity and efficacy after interchangeability of Covid-19 vaccines [Covishield, Covaxin and Sputnik V] among adults in North India: A Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 1,542
- 试验地点
- 1
- 主要终点
- 1. Antibody titers against Spike protein after interchangeability of the study vaccines at baseline, 28 days of first and second dose, 6 months and 1 year.
研究概览
简要总结
Background
In India, currently, Covishield, Covaxin and Sputnik V are being administered to the eligible candidates as homologous prime/boost vaccines. The Center for Disease Control and National Advisory Committee on Immunization have proposed the interchangeability of vaccines to boost immune response and protect the people. However, there is limited evidence that interchangeability of the vaccines will be as effective and safe as the homologous vaccination schedules in India.
Novelty
This study will generate new evidence on the safety, immunogenicity and efficacy of interchangeability vaccine schedules for the vaccines available in India.
Objectives
To ascertain the safety, immunogenicity and efficacy of the Covid-19 vaccines (Covishield/Covaxin/Sputnik V) after interchangeability among adults in North India.
Methods
It will be a multicentric open label parallel non-inferiority randomised control trial to determine safety, efficacy and immunogenicity of heterologous prime/boost COVID-19 vaccine schedules [Covishield:Covaxin; Covishield:Sputnik V; Covaxin:Sputnik V] as compared with homologous schedules [Covishield:Covishield; Covaxin:Covaxin; Sputnik V:Sputnik V]. 1537 volunteers will be randomly allocated into any of the six arms [three heterologous arms and three homologous control arms] i.e, 257 per arm in 1:1 ratio. Adverse events, covid-19 infection rate, and antibody titres against spike protein, neutralizing antibody titres and cell mediated immunity will be assessed at various intervals up to 365 days.
Expected outcomes:
Incidence of breakthrough infection rate, adverse events following immunization, and proportion of individuals with reactive antibody titres against spike protein, neutralizing antibodies and lymphocyte proliferation/raised cytokine levels after heterologous prime/boost COVID-19 vaccine schedules as compared with the homologous group.
1. Keywords: COVID-19 vaccines, Interchangeability, Randomized Controlled Trial, Heterologous prime/boost, Homologous prime/boost, Immunogenicity
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •children less than 18 years.
结局指标
主要结局
1. Antibody titers against Spike protein after interchangeability of the study vaccines at baseline, 28 days of first and second dose, 6 months and 1 year.
时间窗: At at baseline, 28 days of first and second dose, 6 months and 1 year.
2. Incidence of mild, moderate and serious adverse events rate of the Covid-19 vaccines after interchangeability
时间窗: At at baseline, 28 days of first and second dose, 6 months and 1 year.
3. Breakthrough infection rate of the Covid-19 vaccines (Covishield/Covaxin/Sputnik V) after interchangeability.
时间窗: At at baseline, 28 days of first and second dose, 6 months and 1 year.
次要结局
- Neutralizing antibody and celle mediated immune response after interchangeability of covid-19 vaccines(at baseline, 28 days of first and second dose, 6 months and 1 year.)