NCT07003984招募中3 期
A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled, Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children 1 to <12 Years of Age
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 720
- 试验地点
- 15
- 主要终点
- Safety Endpoint 2: Incidence of unsolicited AEs through Day 29
研究概览
简要总结
The goal of this multi-center, randomized, double-blind, placebo-controlled study is to evaluate the safety and immunogenicity of CHIKV VLP Vaccine in children 1 to <12 years of age.
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)
入排标准
- 年龄范围
- 1 Year 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females between 1 and <12 years of age at Day 1 (day of vaccination). Note: Screening should only occur in the active/open cohorts. Please see Section 6.1 for details
- •Body weight ≥6.5 kg.
- •In general good health, in the opinion of the investigator, based on medical history and physical examination.
- •Able and willing to provide informed assent for study participation and primary caregiver is able and willing to provide informed consent for study participation, in accordance with the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) determination and applicable federal and local regulations and guidelines.
- •Able and willing to complete all scheduled visits and comply with all study procedures.
排除标准
- •Participation or planned participation in an investigational clinical study (eg, vaccine, drug) within 30 days before Day 1 and for the duration of the study. Note: Participation in an observational study or follow-up phase of a study may be allowed; these instances should be discussed with the sponsor's medical monitor and written agreement obtained prior to enrollment.
- •Current acute illness, with or without fever.
- •Current or recent CHIKV infection indicated by positive immunoglobulin M (IgM) and negative immunoglobulin G (IgG) rapid diagnostic test (RDT) results at screening in the Philippines only; participants in the US will not be tested using the RDT.
- •History of any known or suspected allergy or history of anaphylaxis to any component of the investigational product.
- •History of any known congenital or acquired immunodeficiency or immunosuppressive condition that could impact response to vaccination.
- •Prior receipt or anticipated use of systemic immunomodulatory or immunosuppressive medications from 180 days prior to screening through Day
- •Note: Systemic corticosteroid use at a dose or equivalent dose of 20 mg or greater (≥0.5 mg/kg for children <40 kg) of prednisone for 14 consecutive days or more within 90 days of screening through Day 22 is exclusionary. The use of inhaled, intranasal, topical, or ocular steroids is allowed.
- •Receipt or anticipated receipt of immunoglobulin from 180 days prior to screening through the duration of the study.
- •Any administration or planned administration of:
- •A licensed live attenuated vaccine within 28 days before administration of investigational product and until Visit 2 (Day 15 or 22, as applicable) has occurred.
- •Other licensed (not live) vaccine within 14 days before administration of investigational product and until Visit 2 (Day 15 or 22, as applicable) has occurred.
- •Another licensed or investigational CHIKV vaccine.
- •Known infection with human immunodeficiency virus, hepatitis C virus (HCV), or hepatitis B virus. Note: Positive anti-HCV antibodies and negative HCV polymerase chain reaction would NOT be exclusionary. Polymerase chain reaction testing will not be performed as part of this protocol.
- •Bleeding disorder or receipt of anticoagulants in the 21 days before Day 1, contraindicating intramuscular vaccination, as judged by the investigator.
- •Receipt or anticipated receipt of blood products from 90 days before Day 1 through the duration of the study.
- •Onset of menarche prior to study vaccination.
- •Planned medical or surgical procedure that could adversely impact the participant's participation or the conduct of the study.
- •Identified as an immediate family member of the investigator or employee with direct involvement in the study. Bavarian Nordic staff members and their families, contractors, agents, business partners, and anyone with a financial interest in the outcome of the study.
- •Any other medical condition, including severe malnutrition, that, in the opinion of the investigator, could adversely impact the participant's participation or conduct of the study.
研究组 & 干预措施
Arm 1
Experimental
Cohort 1 Active Group
干预措施: CHIKV VLP vaccine (Biological)
Arm 2
Placebo Comparator
Cohort 1 Placebo Group
干预措施: Placebo (Biological)
Arm 3
Experimental
Cohort 2 Active Group
干预措施: CHIKV VLP vaccine (Biological)
Arm 4
Placebo Comparator
Cohort 2 Placebo Group
干预措施: Placebo (Biological)
结局指标
主要结局
Safety Endpoint 2: Incidence of unsolicited AEs through Day 29
时间窗: From vaccination on Day 1 through Day 29, 28 days after vaccination with CHIKV VLP vaccine or placebo.
Incidence of unsolicited adverse events (AEs) through Day 29.
Safety Endpoint 3: Incidence of AESI, MAAEs, and SAEs
时间窗: From vaccination through the end of the trial, planned to be Day 732 for study completers.
Incidence of adverse events of special interest (AESIs; defined as new onset or worsening arthralgia that is medically attended), medically attended adverse events (MAAEs), and serious adverse events (SAEs) through end of the trial.
Primary Immunogenicity Endpoint: Day 22 anti-CHIKV SNA seroresponse rate in seronegative children
时间窗: Study Day 22, 21 days after vaccination with CHIKV VLP vaccine or placebo.
Day 22 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate in baseline seronegative children 1 to \<12 years of age in the immunogenicity evaluable population.
次要结局
- Secondary Immunogenicity Endpoint 6: Anti-CHIKV SNA seroresponse rates at Day 732 in the CHIKV VLP vaccine group only(Study Day 732, 731 days after vaccination with CHIKV VLP vaccine.)
- Secondary Immunogenicity Endpoint 7: Day 22 anti-CHIKV SNA seroresponse rate between seronegative children in the IEP versus adolescents and adults study EBSI-CV-317-004(Study Day 22, 21 days after vaccination with CHIKV VLP vaccine or placebo.)
- Key Secondary Immunogenicity Endpoint 1: Day 15 anti-CHIKV SNA seroresponse rate in seronegative children(Study Day 15, 14 days after vaccination with CHIKV VLP vaccine or placebo.)
- Secondary Immunogenicity Endpoint 5a: GMFIs from Day 1 to Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for CHIKV VLP vaccine group only(Day 15, Day 22, Day 183, Day 366, and Day 732, 14, 21, 182, 365, and 731 days after vaccination, respectively.)
- Secondary Immunogenicity Endpoint 5b: Frequency of participants with titer ≥15 and 4-fold rise over baseline at Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for the CHIKV VLP vaccine group only(Day 15, Day 22, Day 183, Day 366, and Day 732, 14, 21, 182, 365, and 731 days after vaccination, respectively.)
- Key Secondary Immunogenicity Endpoint 2: Day 22 anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children(Study Day 22, 21 days after vaccination with CHIKV VLP vaccine or placebo.)
- Secondary Immunogenicity Endpoint 1: Day 15 anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children(Study Day 15, 14 days after vaccination with CHIKV VLP vaccine or placebo.)
- Secondary Immunogenicity Endpoint 2: Day 183 and Day 366 anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children(Study Day 183 and Day 366, 182 and 365 days after vaccination with CHIKV VLP vaccine or placebo, respectively.)
- Secondary Immunogenicity Endpoint 3: Day 15, Day 22, Day 183, and Day 366 anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children(Day 15, Day 22, Day 183, and Day 366, 14, 21, 182, and 365 days after vaccination with CHIKV VLP vaccine or placebo, respectively.)
- Secondary Immunogenicity Endpoint 4: GMTs of anti-CHIKV SNA at Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for CHIKV VLP vaccine group only(Day 15, Day 22, Day 183, Day 366, and Day 732, 14, 21, 182, 365, and 731 days after vaccination, respectively.)
- Safety Endpoint 1: Incidence of solicited adverse events through Day 8(From vaccination on study Day 1 through Day 8, 7 days after vaccination with CHIKV VLP vaccine or placebo.)
研究者
研究点 (15)
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