Phase I Study Evaluating the Basic Pharmacological and Toxicological Effects of the Protective VLP Vaccine Developed Against SARS-CoV-2 in Healthy Participants, Administered as Two Injections Subcutaneously, in Two Different Dosages.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Acute adverse events (AEs)
研究概览
简要总结
This is a VLP SARS-CoV-2 vaccine study of a vaccine developed in Turkey and manufactured according to Good Manufacturing Practices (GMP) requirements. Preclinical toxicology studies on experimental animals are to be concluded. The purpose of this Phase I study is to examine the safety, tolerability, and immunogenicity of the protective VLP vaccine against SARS-CoV-2, which will be administered by a double-blind, randomized method, in two different doses (low dose and high dose).
详细描述
This phase I study is designed as double-blinded, randomised, placebo controlled, three-armed study composed of two different dose arms of protective VLP vaccine (harboring M, N, E, and hexapro modified S proteins of SARS-CoV-2 virus) against SARS-CoV-2 in dose escalations (first low dose group, followed by high dose group) and placebo arm. Each dose of vaccine will be defined as a cohort in itself, with vaccine administration to 12 participants and placebo administration to 6 participants. After completion of low-dose group, decision of switch to high-dose will be taken by the Independent Data Monitoring Committee and study will continue accordingly.
The study will be completed in 12 months.
All injections will be done subcutaneously.
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
Double-blinded
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be eligible for the study, each participant must satisfy all the following criteria:
- •Healthy participants between 18-59 years of age,
- •Sign an informed consent document,
- •Negative immunoglobulin G (IgG) and immunoglobulin M (IgM) antibody for COVID-19,
- •Negative quantitative polymerase chain reaction (qPCR) SARS-CoV-2 results of nasopharyngeal/sputum samples,
- •Able to comply with the study protocol during the study period,
- •Negative tests for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV),
- •Body temperature <37.2 C,
- •Body mass index 18-35 kg/m2,
- •Normal laboratory levels of whole blood count, alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin, urea, creatinine, and fasting blood glucose,
- •Good general health (no known disease in the history and physical examination within 14 days prior to the enrolment),
- •Female participants who are not pregnant or who will be able to have appropriate contraception methods within 30 days prior to vaccine injection and within 6 months after vaccination,
- •Male participants who will be able to have appropriate contraception methods for 6 months after vaccination,
排除标准
- •Participants with any of the following criteria will be excluded:
- •History of seizure, encephalopathy or psychosis,
- •History of allergic reactions to any known vaccine or to any component of the study vaccine,
- •Pregnant, breastfeeding or positive pregnancy test or planning to conceive within 6 months,
- •Active infection signs or body temperature >37.2 C,
- •History of SARS-CoV-2 infection,
- •Severe cardiovascular disorders (arrhythmia, conduction disorders, history of myocardial infarction, uncontrolled hypertension),
- •Severe chronic disorders (asthma, diabetes mellitus, thyroid disorders...etc),
- •Congenital or acquired angioedema,
- •Diagnosis of immunodeficiency,
- •Diagnosis of bleeding diathesis,
- •Use of immunosuppressive treatment, anti-allergic treatment, cytotoxic treatment, inhaler corticosteroids (allergic rhinitis or topical steroid ointments are excluded),
- •Those who received blood and blood product transfusions in the last 6 months,
- •Those on any vaccine program or experimental medication within 1 month prior to the study,
- •History of any live vaccine administration within 1 month prior to the study,
- •History of any inactive vaccine administration within 1 month prior to the study,
- •Use of active tuberculosis treatment,
- •According to the investigator's evaluation, those who have any condition (medical, psychological, social, etc.) that may impair the patient's compliance with the study will be excluded from the study.
研究组 & 干预措施
Low-Dose Group (Group A)
12 participants will receive 10 µg VLP vaccine (adjuvanted with alum and CpGODN-K3)
干预措施: SARS-CoV-2 VLP Vaccine (Biological)
High-Dose Group (Group B)
12 participants will receive 40 µg VLP vaccine (adjuvanted with alum and CpGODN-K3)
干预措施: SARS-CoV-2 VLP Vaccine (Biological)
Placebo Group
12 participants will receive 1 ml of 0.9% sodium chloride (NaCl)
干预措施: Placebo (Biological)
结局指标
主要结局
Acute adverse events (AEs)
时间窗: 24 hours
Frequency of acute AEs in all dosage groups
Solicited local and systemic adverse events (AEs)
时间窗: 6 days
Frequency of local and systemic AEs in all dosage groups
Unsolicited local and systemic adverse events (AEs)
时间窗: 28 days
Frequency of local and systemic AEs in all dosage groups
次要结局
- Cellular immune response (IL-4)(Before booster dose administration, on Day 14-21-28 and at the end of Month 3 and Month 6 after booster dose)
- Neutralizing antibody response(Before booster dose administration, on Day 14-21-28 and at the end of Month 3 and Month 6 after booster dose)
- Specific antibody (IgG) response(Before booster dose administration, on Day 14-21-28 and at the end of Month 3 and Month 6 after booster dose)
- Cellular immune response (IFN-γ)(Before booster dose administration, on Day 14-21-28 and at the end of Month 3 and Month 6 after booster dose)
研究者
Ihsan GURSEL, PhD, Prof.
PhD, Prof
The Scientific and Technological Research Council of Turkey