A Phase 2, Comparative, Randomised, Adaptive Trial to Evaluate the Safety and Immunogenicity of One Dose of Comirnaty® in Subjects That Had Received One Dose of Vaxzevria®
试验速览
- 阶段
- 2 期
- 入组人数
- 600
- 试验地点
- 5
- 主要终点
- To assess the humoral immune response against SARS-CoV-2, 14 days after vaccination with COMIRNATY in subjects that received a previous single dose of VAXZEVRIA, as compared with no dosing.
研究概览
简要总结
CombiVacS is a phase 2 randomized, adaptive trial developed to evaluate the immunogenicity of a dose of COMIRNATY after a previous single dose of VAXZEVRIA. A stratification will be made based on the following factors: study site, sex and age. This protocol allows to test the immunogenicity and safety of a heterologous vaccination strategy after a previous single dose of VAXZEVRIA.
详细描述
This is a randomized, non-blinded, controlled, adaptive, multicenter, Phase II study in subjects aged ≥18 years and in good health or stable clinical situation that have received a previous single dose of VAXZEVRIA. Subjects will be randomized to immediately receive or not a dose of COMIRNATY in a ratio of 2:1. If primary analysis at day 14th confirms the starting hypothesis, subjects randomized to no vaccination will be considered for administration of one dose of COMINARTY at day 28th according to Public Health Department of the Ministry of Health recommendations on heterologous vaccination. In case the primary analysis does not confirm the starting hypothesis, subjects will be followed at the time points defined in the flow-chart without administration of COMIRNATY.
Other heterologous vaccination strategies could be incorporated if deemed necessary for public health reasons. This could include the use of different vaccination strategies including those already marketed vaccines for comparative assessment of their safety and efficacy on SARS-CoV-2 and its variants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Adult subjects (18 years old) having received a prime VAXZEVRIA vaccination between 8 and 12 weeks before the screening visit
- •Participants must provide consent indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study.
- •Subjects in good health or stable clinical situation.
- •Participant is willing and able to adhere to the procedures specified in this protocol.
排除标准
- •Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature ≥38.0ºC within 24 hours prior to the planned dose of study vaccine.
- •Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to COMIRNATY excipients.
- •Subjects with any contraindication to the administration of COMIRNATY, included pregnancy.
- •Subjects with prior documented COVID19 since VAXZEVRIA vaccination.
- •Subjects have symptoms or signs compatible with COVID
- •Subjects participating in a clinical trial in the last three months.
- •Any condition or situation precluding or interfering the compliance with the protocol.
研究组 & 干预措施
VACCINATION
One standard dose of COMIRNATY in adult subjects (18 years old) having received prior VAXZEVRIA vaccination.
干预措施: COMIRNATY (Drug)
结局指标
主要结局
To assess the humoral immune response against SARS-CoV-2, 14 days after vaccination with COMIRNATY in subjects that received a previous single dose of VAXZEVRIA, as compared with no dosing.
时间窗: 14 days after randomization
Antibodies against SARS-CoV-2 spike protein. Measure: BAU/mL
次要结局
- To assess the humoral immune response against SARS-CoV-2, 28 days after vaccination with COMIRNATY in subjects that received a previous single dose of VAXZEVRIA.(28 days after randomization)
- To assess the long-term (up to 1 year) humoral immune response against SARS-CoV-2 of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA.(3, 6 and 12 months after randomization)
- To evaluate the safety of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (serious adverse events)(Month 1-12)
- To assess the occurrence of symptomatic molecularly confirmed COVID-19 and severity of COVID-19 signs and symptoms after the administration of a dose of COMIRNATY in subjects that received a prior single dose of VAXZEVRIA.(Month 1 - 12)
- To evaluate the safety of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (solicited adverse events)(Day 1-7)
- To evaluate the safety of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (unsolicited adverse events)(Day 1-28)
- To evaluate the safety of a dose of COMIRNATY in subjects that received a previous single dose of VAXZEVRIA (Medically-attended adverse events)(Month 1-6)