Double-blind, Randomized, With an Active Control Vaccine, Phase I Clinical Trial for Evaluation of Safety and Immunogenicity of a Recombinant Inactivated COVID-19 Vaccine in Adults in Brazil - ADAPTCOV
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Safety: Adverse reactions.
研究概览
简要总结
NDV-HXP-S is an inactivated COVID-19 vectored-vaccine virus using the Newcastle Disease Virus as basis and expressing S protein from SARS-CoV-2 stabilized in pre-fusion form with Hexapro technology.
This vaccine was successfully tested in non-clinical study with a good safety profile and eliciting neutralizing antibodies against SARS-CoV-2. Clinical testing is conducted by an international consortium including three different manufacturers. Butantan, in Brazil, is one of them.
详细描述
The present protocol aims, to respond to several regulatory requirements to advance the clinical development of the product through a dose-escalation, controlled, randomized, adult clinical trial. The results of the Phase I (former Stage A), allow us to base the decision to evaluate the safety and immunogenicity of three doses of HDV-HXP-S (1μg, 3μg or 10μg).
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
An electronic central randomization system will be used to designate the investigational product (IP) that each participant must receive. A team study non-blind, qualified member (nurse/pharmacist) will obtain the corresponding randomization, will separate the respective IP, will blind the product and deliver it to blind staff. The product will be in a syringe that is in a blister labeled with the sponsor's name, IP code, administration route, IP dose and expiration date. The study non-blind staff will not have contact with the participants, will not have access to identification data or any other involvement with the study, besides randomizing the participant, separating the syringe containing placebo or vaccine, checking if the information on the blister label corresponds the information on the cartridge label and the syringe is labeled with the clinical trial code, ID, corresponding visit and investigator's name. Blinding is maintained with the opacity of the label.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Safety: Adverse reactions.
时间窗: 7 days after each vaccination.
Number and intensity of solicited local and systemic adverse reactions.
Safety: Laboratory evaluations
时间窗: 7 days after each vaccination.
Number, severity and summary of clinically significant changes of hematological (hemoglobin \[g/dL\], white blood cells \[cells/mm³\] and platelets \[count per mm³\]) and biochemical evaluations (creatinine \[mg/dL\], AST \[U/L\], ALT \[U/L\], and total bilirubin \[mg/dL\]) since the baseline within 7 days after each vaccination.
Immunogenicity: Neutralization GMT SARS-CoV-2 pseudovirus.
时间窗: 42(+7) days after the first dose.
Neutralization GMT against SARS-CoV-2 pseudovirus (beta and gamma strains)
Immunogenicity: Percentage of seroconversion.
时间窗: 42(+7) days after the first dose.
Percentage of positive SARS-CoV-2 pseudovirus neutralization assay in a participant with a baseline negative result (Wuhan strain).
次要结局
- Immunogenicity: Levels of antibodies.(At baseline, 28 days after the first vaccination, and 14 days after the second vaccination, and 3, 6, 9, and 12 months after first vaccination.)
- Safety: serious and medically-attended adverse reactions.(Throughout the entire study period.)
- Safety: events of special interest.(Throughout the entire study period.)
- Safety: all unsolicited adverse reactions.(28 days after each vaccination.)
- Exploratory Endpoints: Neutralization GMT of SARS-CoV-2 pseudovirus.(at 3 months, 6 months, 9 months, and 12 months after first vaccination in subjects.)
- Exploratory Endpoints - COVID-19 cases.(14 days after first and second vaccination.)
- Exploratory Endpoints: Levels of antibodies.(At baseline, 28 days after the first vaccination, and 14 days after the second vaccination, and 3 months, 6 months, 9 months, and 12 months after first vaccination.)
- Immunogenicity: Neutralization GMT of SARS-CoV-2 pseudovirus.(28 days after the first vaccination, and 14 days after the second vaccination.)