A Phase I/II Study to Determine Efficacy, Safety and Immunogenicity of the Candidate Coronavirus Disease (COVID-19) Vaccine ChAdOx1 nCoV-19 in UK Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 1,077
- 试验地点
- 6
- 主要终点
- Assess efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19: Number of virologically confirmed (PCR positive) symptomatic cases
研究概览
简要总结
A phase I/II single-blinded, randomised, multi-centre study to determine efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in UK healthy adult volunteers aged 18-55 years. The vaccine will be administered intramuscularly (IM) into the deltoid region of the arm
详细描述
There will be 4 study groups and it is anticipated that a total of 1090 volunteers will be enrolled. Volunteers will participate in the study for approximately 12 months from last vaccination visit (approximately 15 months from enrolment for participants receiving 2 doses)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1a
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19
干预措施: ChAdOx1 nCoV-19 (Biological)
Group 1b
Volunteers will receive a standard single dose of MenACWY vaccine
干预措施: MenACWY (Biological)
Group 1c
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 at week 0 and a boost dose of 5x10^10vp ChAdOx1 nCoV-19 9 months later
干预措施: ChAdOx1 nCoV-19 (Biological)
Group 1c
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 at week 0 and a boost dose of 5x10^10vp ChAdOx1 nCoV-19 9 months later
干预措施: ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp) late vaccine (LV) (Biological)
Group 1d
Volunteers will receive a standard single dose of MenACWY vaccine. 9 moths later they will receive two doses of 5x10^10vp ChAdOx1 nCoV-19 4-12 weeks apart
干预措施: MenACWY (Biological)
Group 1d
Volunteers will receive a standard single dose of MenACWY vaccine. 9 moths later they will receive two doses of 5x10^10vp ChAdOx1 nCoV-19 4-12 weeks apart
干预措施: ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp) late vaccine two (LVT) (Biological)
Group 2a
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19
干预措施: ChAdOx1 nCoV-19 (Biological)
Group 2b
Volunteers will receive a standard single dose of MenACWY vaccine
干预措施: MenACWY (Biological)
Group 4b
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 delivered intramuscularly
干预措施: MenACWY (Biological)
Group 2c
Volunteers will receive two doses of 5x10^10vp ChAdOx1 nCoV-19 at week 0 and week 8
干预措施: ChAdOx1 nCoV-19 full boost (Biological)
Group 2d
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 at week 0 and a boost dose of 2.5x10^10vp ChAdOx1 nCoV-19 at week 8
干预措施: ChAdOx1 nCoV-19 half boost (Biological)
Group 2e
Volunteers will receive two standard single doses of MenACWY vaccine at week 0 and week 8
干预措施: MenACWY boost (Biological)
Group 2f
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 at week 0 and a boost dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) a minimum of 4 weeks later
干预措施: ChAdOx1 nCoV-19 0.5mL boost (Biological)
Group 2g
Volunteers will receive two standard single doses of MenACWY vaccine a minimum of 4 weeks apart
干预措施: MenACWY boost (Biological)
Group 3a
Volunteers will receive one dose of 5x10^10vp ChAdOx1 nCoV-19 at week 0 and one dose of 5x10^10vp ChAdOx1 nCoV-19 at week 4
干预措施: ChAdOx1 nCoV-19 full boost (Biological)
Group 3b
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 at week 0, a boost dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) a minimum of 4 weeks later, and a third dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) at 9 months
干预措施: ChAdOx1 nCoV-19 full boost (Biological)
Group 3b
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 at week 0, a boost dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) a minimum of 4 weeks later, and a third dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) at 9 months
干预措施: ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp) late vaccine (LV) (Biological)
Group 4a
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19
干预措施: ChAdOx1 nCoV-19 (Biological)
Group 4a
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19
干预措施: Paracetamol (Drug)
Group 4b
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 delivered intramuscularly
干预措施: Paracetamol (Drug)
Group 4c
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 at week 0 and a boost dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) a minimum of 4 weeks later
干预措施: ChAdOx1 nCoV-19 (Biological)
Group 4c
Volunteers will receive a single dose of 5x10^10vp ChAdOx1 nCoV-19 at week 0 and a boost dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) a minimum of 4 weeks later
干预措施: ChAdOx1 nCoV-19 0.5mL boost (Biological)
Group 4d
Volunteers will receive two standard single doses of MenACWY vaccine a minimum of 4 weeks apart
干预措施: MenACWY boost (Biological)
Group 5a
Volunteers will receive two doses of 5x10^10vp ChAdOx1 nCoV-19 ≤ 16 weeks apart, and a third dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) at 9 months
干预措施: ChAdOx1 nCoV-19 full boost (Biological)
Group 5a
Volunteers will receive two doses of 5x10^10vp ChAdOx1 nCoV-19 ≤ 16 weeks apart, and a third dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) at 9 months
干预措施: ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp) late vaccine (LV) (Biological)
Group 5b
Volunteers will receive two standard single doses of MenACWY vaccine ≤ 16 weeks apart, a dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) at 9 months then a second dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) 4-12 weeks later
干预措施: MenACWY boost (Biological)
Group 5b
Volunteers will receive two standard single doses of MenACWY vaccine ≤ 16 weeks apart, a dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) at 9 months then a second dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x1010vp) 4-12 weeks later
干预措施: ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp) late vaccine two (LVT) (Biological)
结局指标
主要结局
Assess efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19: Number of virologically confirmed (PCR positive) symptomatic cases
时间窗: 6 months
Number of virologically confirmed (PCR or NAAT positive) symptomatic cases of COVID-19
Assess the safety of the candidate vaccine ChAdOx1 nCoV: Occurrence of serious adverse events (SAEs)
时间窗: Throughout the study, average of 18 months
Occurrence of serious adverse events (SAEs) throughout the study until a cutoff date of 1st July 2021 or 6 months post late vaccination visit, whichever is latest
次要结局
- Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited systemic reactogenicity signs and symptoms(7 days following vaccination)
- Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of solicited local reactogenicity signs and symptoms(7 days following vaccination)
- Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV: Occurrence of unsolicited adverse events (AEs)(7 or 28 days following vaccination)
- Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV through standard blood tests(6 months)
- Assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV by measuring the number of disease enhancement episodes(6 months)
- Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by hospital admissions(6 months)
- Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by ICU admissions(6 months)
- Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by COVID-19 related deaths(6 months)
- Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19(6 months)
- Assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 by measuring seroconversion rates(6 months)
- Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19 through ELISpot assays(6 months)
- Assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19(6 months)