Evaluation of Immunogenicity and Duration of Immunity of the IXCHIQ® Vaccine Against CHIKV
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Celular immunogenicity
研究概览
简要总结
The goal of this clinical trial is to evaluate the quality and duration of the immune response against chikungunya virus elicited by the IXCHIQ® vaccine in healthy adults and adolescents. The main questions it aims to answer are:
Is the cellular immune response elicited by IXCHIQ® adequate for Chikungunya prevention? Is the IXCHIQ® vaccine safe? How does the immune response elicited by IXCHIQ® behave at the different time points evaluated?
Participants will:
Receive the IXCHIQ® vaccine; Be evaluated by medical personnel and have a blood sample taken on days 3, 7, 30, 180, and 720 after vaccination; Be contacted by phone 60 days after vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 59 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The participant or guardian understands the procedures and requirements, and is willing and able to provide informed consent for full participation in the study;
- •Individuals of both sexes aged 12 to 59 years.
排除标准
- •Participants under 12 years of age or 60 years of age or older;
- •Those with any contraindication identified in Ministry of Health Technical Note No. 9/2026-CGFAM/DPNI/SVSA/MS (https://www.gov.br/saude/pt-br/centrais-de-conteudo/publicacoes/notas-tecnicas/2026/nota-tecnica-no-9-2026-cgfam-dpni-svsa-ms.pdf - Technical Note: Guidelines for monitoring the safety of the Chikungunya vaccine used during the pilot vaccination strategy in Brazil - 2026);
- •Participants unavailable to attend the planned study visits;
- •Participants who do not agree to sign the Informed Consent Form (ICF);
- •Positive β-hCG test on the day of vaccination, for women of reproductive potential;
- •Participants who are pregnant or planning to become pregnant within the 3 months following the vaccine dose;
- •Participants who are breastfeeding;
- •Participants with a known or suspected immune system defect that could influence the immune response to the vaccine, such as congenital or acquired immunodeficiency-including HIV infection, post-organ transplant status, or immunosuppressive therapy within 4 weeks prior to Visit
- •Immunosuppressive therapy is defined as the chronic administration of prednisone (more than 14 days) or an equivalent at a dosage of ≥2 mg/kg/day during the 4 weeks prior to study entry. Note: radiotherapy or cytotoxic immunosuppressive drugs/monoclonal antibodies within the previous 3 years; topical and inhaled steroids are permitted.
- •Any clinical instability identified by the attending physician that could place the participant at risk.
研究组 & 干预措施
IXCHIQ vaccine
IXCHIQ vaccine
干预措施: IXCHIQ vaccine (Biological)
结局指标
主要结局
Celular immunogenicity
时间窗: 3 years
Number and percentage of the various vaccine-induced mononuclear and polymorphonuclear populations, as assessed by flow cytometry, comparing age groups.
次要结局
- Safety evaluation(60 days)
- Neutralizing antibodies duration(3 years)
- Immunological profile evaluation(3 years)
- Immunological crossover(3 years)
研究者
Mauro Martins Teixeira
MD, Phd
Federal University of Minas Gerais