Phase 3b, Multicenter, Randomized, Controlled, Double-Blind Clinical Trial to Evaluate the Immunogenicity and Safety of the Co-administration of Live Attenuated Dengue and Chikungunya Vaccines in Adults Aged 18 to 59 Years.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 900
- 试验地点
- 7
- 主要终点
- Immunogenicity Primary
研究概览
简要总结
This randomized, controlled, double blind trial aims at assessing the safety and immunogenicity profiles of the co-administered Live Attenuated Dengue and Chikungunya vaccines comparatively to the isolated administration, in the adult population aged 18 to 59 years without prior exposure to either arbovirus.
详细描述
A Phase 3b multicenter, randomized, controlled, double-blind clinical trial was designed to evaluate the Immunogenicity (non-inferiority), 28 days post-immunization, for each Dengue and Chikungunya serotypes, as well as the safety, 21 days post-immunization, of the co-administration of the live attenuated Dengue and Chikungunya vaccines compared to the separate administration in adults aged 18 to 59 years without prior exposure to either arbovirus.
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)
盲法说明
To ensure blinding of both participants and the study team performing safety assessments, vaccine preparation will be conducted by unblinded team members in a separate room, following the four-eyes principle (two individuals supervising the process). The syringes for different vaccination regimens will be pre-masked before being delivered to the study sites, ensuring the blinding process is maintained.
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
- •Male or female adults aged 18 to 59 years at the time of vaccination.
- •Signed informed consent by the participant or their legal representatives.
- •Ability to understand, based on the investigator's assessment, and agree to comply with all study procedures, including blood collection.
排除标准
- •Participation in another clinical trial within 28 days prior to screening or planned participation in another clinical study during the trial period.
- •Pre-existing unstable health condition. An unstable health condition is defined as a disease requiring a change in treatment or hospitalization due to disease worsening within 90 days prior to screening.
- •Vaccination within 14 days prior to screening with any inactivated vaccine or within 28 days prior to screening with any live attenuated vaccine, or planned vaccination with any vaccine up to 28 days after study vaccination.
- •Known hypersensitivity to any component of the vaccines.
- •Thrombocytopenia or bleeding disorders that contraindicate intramuscular vaccination or venipuncture for blood collection.
- •Receipt of immunoglobulins, blood, or blood products within 180 days prior to screening.
- •Altered immunocompetence (immunosuppression, immunodeficiency, or immunocompromise) primary or secondary due to: Clinical conditions (including but not limited to renal failure, liver failure with cirrhosis, heart failure class III or IV according to the New York Heart Association, HIV infection, and asplenia).
- •Use of systemic corticosteroids (oral, intravenous, or intramuscular) at a dose equivalent to ≥20 mg/day of prednisone for more than 14 days or a cumulative dose greater than 280 mg within the last 90 days prior to screening. Topical, inhaled, and intranasal corticosteroids are allowed. Intermittent use (a single dose within the last 30 days prior to screening) of intra-articular corticosteroids is also allowed.
- •Receipt of antineoplastic agents, immunosuppressants, immunomodulators, or radiotherapy within the last 180 days prior to screening.
- •Malignancy at the time of screening or a history of malignancy with <5 years of disease-free status at screening (except for basal cell carcinoma of the skin and localized prostate cancer under active surveillance).
- •Abuse of alcohol and illicit drugs within the past 12 months before screening that may compromise study compliance, at the investigator's discretion.
- •Being part of the study team, having a first-degree relative (parents, children, in-laws, stepchildren, sons-in-law, or daughters-in-law) or living in the same household as a study team member.
- •Any other clinical condition that, in the investigator's opinion, may interfere with the study results or pose an additional risk to the participant due to study inclusion.
- •Prior exposure to dengue and chikungunya viruses, i.e., non-reactive IgM and IgG as screened by specific ELISA for both viruses. In case of doubt or indeterminate ELISA results, at least two consecutive samples will be collected. If doubt persists after two test collections, the participant will be excluded.
- •For female participants of childbearing potential: Pregnancy (confirmed by a positive β-hCG test), breastfeeding, or intention to engage in sexual activity with reproductive potential without using a contraceptive method for 90 days following vaccination.
- •Previous receipt of any dengue or chikungunya vaccine.
研究组 & 干预措施
Chikungunya vaccine only
A single dose of VLA1555 + placebo, administered concomitantly in opposite arms on Day 1.
干预措施: Chikungunya (CHIKV) live attenuated vaccine (VLA1555) (Biological)
Dengue and Chikungunya vaccines co-administered
A single dose of Butantan-DV + a single dose of VLA1555, administered concomitantly in opposite arms on Day 1.
干预措施: DENGUE: Dengue 1,2,3,4 (attenuated) vaccine CHIKUNGUNYA: Chikungunya (CHIKV) live attenuated vaccine (VLA1555) (Biological)
Dengue vaccine only
A single dose of Butantan-DV + placebo, administered concomitantly in opposite arms on Day 1.
干预措施: DENGUE: Dengue 1,2,3,4 (attenuated) vaccine (Biological)
结局指标
主要结局
Immunogenicity Primary
时间窗: 28 days post-immunization
Demonstrate the non-inferiority of the antibody response of co-administered Dengue and Chikungunya vaccines compared to Dengue and Chikungunya vaccines administered separately, for each Dengue serotype and Chikungunya in the adult population aged 18 to 59 years without prior exposure to either arbovirus, by calculating the Geometric Mean Titer (GMT) and the GMT ratio, post-immunization for each dengue serotype and chikungunya, across all intervention groups.
Safety Primary
时间窗: 21 days post-immunization
Assess the safety profile of co-administered Dengue and Chikungunya vaccines and Dengue and Chikungunya vaccines administered separately, in the adult population aged 18 to 59 years without prior exposure to either arbovirus, through the frequency of participants with solicited (local and systemic) and unsolicited adverse events (AEs), in all intervention groups.
次要结局
- Immunogenicity Secondary 1(28 days post-immunization)
- Immunogenicity Secondary 2.(180 days post-immunization.)
- Safety Secondary 1.(up to 21 days post-immunization.)
- Safety Secondary 2.(180 days post-immunization)
- Safety Secondary 3.(Days 1, 6, 9, 16, and 22.)