A Phase I-II, Blinded, Randomized, Placebo-controlled Study of a T Cell Priming Next-generation Vaccine Against Coronavirus Disease in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- To assess the safety, tolerability and reactogenicity of the vaccine
研究概览
简要总结
The study aims to investigate the safety and immunogenicity of one dose vs two doses of a T-cell priming next-generation vaccine against Coronavirus disease.
详细描述
The scale of the COVID-19 pandemic requires multiple vaccine candidates to ensure equitable and rapid access to protection by:
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Providing a range of vaccine choices tailored to variations in immunological profiles across demographics as well as suited to environments with various levels of resources (cold chain etc).
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Distributing and parallelizing manufacture, to speed up scale, avoid reagent stockouts and dilute monopolies
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The ability for SARS -CoV-2 (Severe Acute Respiratory Syndrome Coronavirus-2) to mutate, requires multiple vaccine candidates to ensure robust and sustainable protection. Vaccines with a range of epitopes and immune targets provide immunological diversity and reduce vulnerability to mutant escape.
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Nanotechnology fulfils the needs of a Universal Coronaviruses vaccine by being a rapidly scalable and modular platform
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Humoral immunity may be transient and insufficient against emerging variants of SARS-CoV-2
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Cellular immunity against SARS-CoV-2 is lasting and associated with recovery in COVID-19. A vaccine (prime or booster) inducing the right T cell response can be the solution against the need to develop new vaccines every time the virus mutates or a new variant persists.
This is a Phase I-II, double-blind, randomized, placebo-controlled study investigating the safety and immunogenicity of a T cell priming next-generation vaccine against Coronavirus disease in healthy adults.
The clinical study will enrol 110 participants (88 vaccine vera and 22 placebo, [split 50:50 between two groups one receiving one vaccination and the other two vaccinations]).
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
- Double (Participant, Investigator)
盲法说明
- This trial is double-blinded (blinded to investigators and participants)
- Blinding will be maintained for the duration of the study.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers aged 18 to 75 years on the day of inclusion
- •Participant signed informed consent
- •Residing in Philippines.
- •A participant can be included providing COVID-19 polymerase chain reaction (PCR) test is negative at screening.
- •A participant can be included providing, the participant haven't received any vaccination against COVID-19 in the past, or if the participant had already received any of the following licensed vaccines against COVID-19: Oxford/AstraZeneca; Pfizer/BioNTech; Moderna; or J&J/Janssen, with the participants last dose received at least 6 months prior the inclusion in this trial.
排除标准
- •Participant is pregnant, lactating, or of childbearing potential
- •Participation in the 6 months preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- •Receipt of any vaccination against COVID-19 less than 6 months prior to participation in study.
- •Receipt of any vaccine in the three months preceding the first trial vaccination or planned receipt of any vaccine in the 6 months following last trial vaccination.
- •Positive SARS-CoV-2 test in the 4 weeks preceding the first trial vaccination
- •Receipt of immunoglobulins, blood, or blood-derived products in the past 3 months
- •Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy
- •Self-reported or documented seropositivity for human immunodeficiency virus (HIV), hepatitis B natural infection (HBcAb positive serology), or hepatitis C
- •Known systemic hypersensitivity to any of the vaccine components (e.g. gold), or history of a life-threatening reaction to vaccines or to a vaccine containing any of the same substances
- •Current alcohol abuse or drug addiction (reported or suspected)
- •Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- •Thrombocytopenia or any coagulation disorder
- •Identified as an Investigator or employee of the Investigator or study centre with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study (i.e. in the employment of the clinical trial sites).
- •Refusal to be informed if relevant results concerning the participant's health are revealed
研究组 & 干预措施
PepGNP-COVID19 (One vaccination)
One vaccination of PepGNP-COVID19 vaccine candidate administered on Day 0 (50 µl per dose)
干预措施: PepGNP-COVID19 (One vaccination) (Biological)
Placebo (One vaccination)
One vaccination of WFI administered on Day 0 (50 µl per dose)
干预措施: Water for injection (One vaccination) (Other)
PepGNP-COVID19 (Two vaccinations)
Two vaccinations of PepGNP-COVID19 vaccine candidate administered on Day 0 and Day 21 (50 µl per dose)
干预措施: PepGNP-COVID19 (Two vaccinations) (Biological)
Placebo (Two vaccinations)
Two vaccinations of WFI administered with on Day 0 & Day 21 (50 µl per dose)
干预措施: Water for injection (Two vaccinations) (Other)
结局指标
主要结局
To assess the safety, tolerability and reactogenicity of the vaccine
时间窗: 6 months following first vaccination or End Of Study (EOS), whichever is later
Occurrence of solicited local reactogenicity signs and symptoms up to 7 days after each injection. Occurrence of solicited systemic reactogenicity signs and symptoms up to 14 days after each injection. Occurrence of unsolicited adverse events, serious adverse events (SAEs), and adverse events of special interest (AESI) up to 6 months following first vaccination or End Of Study (EOS), whichever is later.
次要结局
- Assess the humoral immunogenicity of the vaccine candidate(180 days following first vaccination)
- Assess the cellular immunogenicity of the vaccine candidate(180 days following first vaccination)