NCT07467707招募中3 期
A Phase 3b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of an Adjuvanted Chikungunya Virus Virus-like Particle (CHIKV VLP) Vaccine for the Prevention of Chikungunya Disease in Adolescents (12 to <18 Years) and Adults (≥18 Years)
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 6,144
- 试验地点
- 3
- 主要终点
- Incidence of laboratory-confirmed acute CHIKV disease
研究概览
简要总结
Study EBSI-CV-317-007 is a field study to evaluate the efficacy, immunogenicity, and safety of CHIKV VLP vaccine. The study was designed using infectious disease models and advanced analytics to guide region and clinical site prioritization, define the timing of study activities, and optimize the study parameters to local epidemiological conditions for CHIKV disease to overcome the challenges of assessing efficacy for CHIKV VLP vaccine.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able and willing to provide informed consent (and assent, as applicable) voluntarily signed by participant (and guardian, as applicable). Must verbalize understanding of the reason for and the procedures needed for the study and be willing to stay in the study for its entire duration.
- •Male or nonpregnant female 12 years of age and older.
- •In stable health per the investigator, and no hospital admission or major surgical procedure in the last 30 days before investigational product administration.
- •Women who are either:
- •Not of CBP: premenarchal, surgically sterile (at least 6 weeks post bilateral tubal ligation, bilateral salpingectomy, bilateral oophorectomy, or hysterectomy); or postmenopausal (defined as a history of ≥12 consecutive months without menses prior to randomization in the absence of other pathologic or physiologic causes, following cessation of exogenous sex-hormonal treatment). or
- •Meeting all the below criteria:
- •Negative urine pregnancy test at screening visit
- •Negative urine pregnancy test immediately prior to dosing
- •Using an acceptable form of contraception per local standards and agree to use this for at least 8 weeks after investigational product administration
- •Note: Contraception requirements do not apply for participants in exclusively same-sex relationships and these participants should have no plans to become pregnant by any other means for at least 8 weeks after investigational product administration.
排除标准
- •Currently pregnant or breastfeeding.
- •Participation or planned participation in an investigational clinical study within 30 days of Day 1 (investigational product administration) and for the duration of the study. Note: Participation in an observational trial/study or follow-up phase of a trial/study may be eligible; however, participation in any other study should be discussed with the MM prior to enrollment.
- •History of severe allergic reaction or anaphylaxis to any component of the investigational product.
- •Prior receipt of any CHIKV vaccine (or therapeutic) or participation in a prior interventional CHIKV trial/study.
- •Prior documented, laboratory confirmed CHIKV disease.
- •History of any known congenital or acquired immunodeficiency or immunosuppressive condition that could impact response to investigational product administration (eg, leukemia, lymphoma, malignancy, functional or anatomic asplenia, alcoholic cirrhosis). Notes: i) history of basal cell and squamous cell carcinoma of the skin or carcinoma in situ of the cervix considered cured is not exclusionary; ii) history of malignancy considered cured from over 5 years from the date of screening with minimal risk of reoccurrence or relapse is not exclusionary; iii) documented controlled HIV infection (most recent tests show undetectable viral load and a CD4 cell count over 350 at the time of investigational product administration) is not exclusionary.
- •Prior receipt or anticipated use of systemic immunomodulatory or immunosuppressive medications including hyperimmune products, monoclonal antibody therapies, systemic corticosteroids, and/or therapy with alkylating agents, antimetabolites, or radiation from 6 months prior to screening through Day 22 visit (21 days [-3/+5] after investigational product administration). Note: i) for systemic corticosteroid uses at a dose or equivalent dose of 20 mg of prednisone daily for 14 days or more within 90 days of screening through Day 22 visit is exclusionary, and ii) use of inhaled, intranasal, topical, or ocular steroids is not exclusionary.
- •Receipt or anticipated receipt of any vaccine from 30 days prior to Day 1 through Day 22 visit.
- •Unstable medical condition in the last 30 days prior to Day
- •Acute illness with or without fever (oral temperatures ≥38.0 ºC [100.4 °F]) within 14 days prior to investigational product administration.
- •Medical or social condition (eg, substance abuse) that could have an impact on the participant's ability to be compliant with study procedures/visits, as determined by the investigator.
- •Plans to travel outside the study area or move away for more than 3 consecutive months and will not be available for follow up at the site.
- •Identified as an investigator or employee of an investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse) of the investigator or employee with direct involvement in the proposed study, or identified as an employee of Bavarian Nordic, their families, contractors, agents, business partners, or anyone with a financial interest in the outcome of the study.
- •Any other medical condition that, in the opinion of the investigator, could adversely impact the participant's participation or the conduct of the study.
研究组 & 干预措施
Arm 1: Cohort 1 Active Group
Active Comparator
CHIKV VLP/adjuvant
干预措施: CHIKV VLP vaccine (Biological)
Arm 2: Cohort 1 Placebo Group
Placebo Comparator
Placebo
干预措施: Placebo (Biological)
结局指标
主要结局
Incidence of laboratory-confirmed acute CHIKV disease
时间窗: From 14 days postvaccination through end of study follow-up, up to 1095 days postvaccination
Laboratory-confirmed acute CHIKV disease is defined by the presence of fever, one or more of arthralgia, myalgia or rash, and reverse transcription-quantitative polymerase chain reaction (RT-qPCR) confirmation of CHIKV ribonucleic acid.
次要结局
- Incidence of laboratory-confirmed chronic CHIKV disease(98 days postvaccination through end of study follow-up, up to 1095 days postvaccination)
- Incidence of laboratory-confirmed severe CHIKV disease.(14 days postvaccination through end of study follow-up, up to 1095 days postvaccination)
- Number of participants with Solicited or Local Adverse Events(Within 7 days postvaccination)
- Number of participants with Unsolicited Adverse Events(Within 28 days postvaccination)
- Number of Participants with Serious Adverse Events(Through end of study follow-up, up to 1095 days postvaccination)
- Number of Participants with Adverse Events of Special Interest(Through end of study follow-up, up to 1095 days postvaccination)
- Number of Participants with Medically Attended Adverse Events(Through end of study follow-up, up to 1095 days postvaccination)
- Anti-CHIKV Serum Neutralizing antibody titers(3 weeks postvaccination)
- Anti-CHIKV Serum Neutralizing Antibody seroresponse rate(3 weeks postvaccination)
研究者
研究点 (3)
Loading locations...
相似试验
进行中（未招募）
1 期
A Trial of SHR-2173 in Healthy VolunteersNCT07390747Atridia Pty Ltd.18
招募中
3 期
Trial to Evaluate Immunogenicity Non-Inferiority, Safety and Lot-to-Lot Consistency of Biovac OCV-S to Euvichol®-PlusNCT07304284International Vaccine Institute2,824
进行中（未招募）
3 期
Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Immunobridging to Adults 18-49NCT07284654Vaxcyte, Inc.4,049
尚未招募
1 期
A Phase 1 Comparative Study to Evaluate Pharmacokinetics, Immunogenicity, Safety and Tolerability of Bmab3000 and Herceptin Hylecta® After a Single 600 mg SC Injection in Healthy Male VolunteersNCT07299955Biocon Biologics UK PLC150
尚未招募
Unknown
Phase IV Multicentre Study on the Safety and Immunogenicity of Recombinant Hepatitis E Vaccine (E. coli) in Healthy AdultsCTRI/2025/12/099590Urihk Pharmaceutical Private Limited (Subsidiary of Ureka Hong Kong)1,000