NCT06101173已完成1 期
A Randomized, Observer-Blind, Positive-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) in Healthy Adults Aged 18-54 Years
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Occurrence of solicited adverse reactions (AEs) within 7 days post vaccination.
研究概览
简要总结
This is a randomized, observer-blind, positive-controlled study. There will be 3 treatment groups, in each treatment group, participants will be randomly assigned to receive either investigational vaccine (Low-adjuvant dose VLP-Polio, Medium dose VLP-Polio, or High dose VLP-Polio that are defined as Dose A, Dose M, and Dose H, respectively) or control vaccine in a ratio of 3:1 in each group. Distribution of participant's gender should be balanced in each group.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female volunteers aged 18 to 54 years at time of screening.
- •Participants who can understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent.
- •Healthy or in stable health participants with pre-existing, stable, well-controlled disease, defined as mild disease or medical condition not requiring medical therapy or not requiring a change in medical therapy due to worsening of disease during the 6 months before enrollment may be enrolled at the discretion of the investigator.
- •Female participants of childbearing potential must have a negative pregnancy test at screening and before the administration of investigational vaccine and have been using/ agree to use an adequate form of contraception 30 days prior to screening until 180 days post administration.
- •Male participants must agree to use adequate contraception 30 days prior to screening until 180 days after the vaccination.
排除标准
- •Tympanic temperature >37.4°C.
- •Evidence of excessive alcohol or drug abuse.
- •Have received any polio vaccines within 6 months prior to screening.
- •History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.
- •Pregnant or lactating at screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period.
- •History of epilepsy or convulsions.
- •Have developmental cognitive disability, dementia, or intellectual disabilities.
- •Immune deficiency or immune suppressive treatment or auto-immune disease. For corticosteroids, a prednisone dose of <20 mg/day or equivalent is allowed. Inhaled and topical corticosteroids are allowed.
- •Current diagnosis of polio or history of polio infection.
- •Positive for HIV, Hepatitis B or Hepatitis C.
- •Positive for COVID-19 test.
- •Bleeding disorders or the usage of anticoagulants.
- •Have received any other immunizations within 14 days prior to screening.
- •Suffering from serious chronic disease or the disease is in progress and cannot be controlled, such as thyroid diseases (excluding thyroid nodules).
- •Have received blood products within the past 3 months or plan to receive during the study period.
- •Participate in other studies within 30 days (<30 days) before and/or during the study period.
- •Abnormal safety laboratory parameters during the screening window that are clinically significant as per the judgement of the investigator.
- •Any other factors that might interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participants to participate, in the opinion of the treating investigator.
研究组 & 干预措施
Experimental vaccine group A, Low dose, Intramuscular injection (IM)
Experimental
1 dose of Low-adjuvant dose VLP-Polio vaccine on Visit 1
干预措施: Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio) (Biological)
Control vaccine group A, IM
Active Comparator
1 dose of IPOL vaccine on Visit 1
干预措施: Inactivated poliomyelitis vaccine (IPOL) (Biological)
Experimental vaccine group B, Medium dose, Intramuscular injection (IM)
Experimental
1 dose of Medium dose VLP-Polio vaccine on Visit 1
干预措施: VLP-Polio (Biological)
Control vaccine group B, IM
Active Comparator
1 dose of IPOL vaccine on Visit 1
干预措施: IPOL (Biological)
Experimental vaccine group C, High dose, Intramuscular injection (IM)
Experimental
1 dose of High dose VLP-Polio vaccine on Visit 1
干预措施: VLP-Polio (Biological)
Control vaccine group C, IM
Active Comparator
1 dose of IPOL vaccine on Visit 1
干预措施: IPOL (Biological)
结局指标
主要结局
Occurrence of solicited adverse reactions (AEs) within 7 days post vaccination.
时间窗: Within 7 days post vaccination
次要结局
- Occurrence of unsolicited AEs within 28 days post-vaccination.(Within 28 days post-vaccination)
- Occurrence of solicited AEs within 30 mins post-vaccination.(Within 30 mins post-vaccination)
- Occurrence of abnormal safety laboratory parameters on Day 3, Day 8.(Day 3, Day 8 post-vaccination)
- Geometric mean fold increase (GMI) of neutralizing antibodies against poliovirus type 1, 2, and 3 on Day 1 before vaccination and Day 29 and Day 180 after the vaccination.(Day 1 before vaccination and Day 29 and Day 180 after the vaccination)
- Seroconversion rate of neutralizing antibodies against poliovirus type 1, 2, and 3 on Day 1 before vaccination and Day 29 and Day 180 after the vaccination.(Day 1 before vaccination and Day 29 and Day 180 after the vaccination)
- Occurrence of serious adverse events (SAEs) during the study period.(Through study completion, an average of 6 months)
- Geometric mean titer (GMT) of neutralizing antibodies against poliovirus type 1, 2, and 3 on Day 1 before vaccination and Day 29 and Day 180 after the vaccination.(Day 1 before vaccination and Day 29 and Day 180 after the vaccination)
研究者
研究点 (1)
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