A Phase 2, Open-Label, Single-Center, Long-Term Immunogenicity Follow-Up Study of the GVGH altSonflex1-2-3 Shigella Vaccine 1, 2 and 3 Years After Vaccination in African Children
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 528
- 主要终点
- Anti-serotype specific Shigella lipopolysaccharide (LPS)/O-antigen (OAg) serum immunoglobulin G (IgG), as measured by GVGH enzyme-linked immunosorbent assay . (ELISA)
研究概览
简要总结
The current study is a follow-up to 2 previous parent studies, a dose-selection study with 3 different dose-levels of the altSonflex1-2-3 vaccine in a schedule of 3 vaccinations (H06_01TP study [NCT05073003, 212149]) and a study with an alternate 2 vaccination schedule H06_02TP study [NCT06663436, 219449]). The current study aims to assess the longevity of the immune response to the selected dose of the altSonflex1-2-3 vaccine 1, 2, and 3 years after the last vaccination in African children. The study involves no new vaccinations but will collect immunogenicity blood samples from participants.
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
- None
盲法说明
This is an open-label study.
入排标准
- 年龄范围
- 26 Months 至 55 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children who, as infants, previously participated in two completed studies (H06_01TP or H06_02TP) and were vaccinated with 3 or 2 doses of altSonflex1-2-3 or control vaccines, respectively, completed all previous vaccinations and are 12±1 months after the last altSonflex1-2-3 vaccination.
- •Individuals in good health as determined by medical history since last study visit and clinical judgment of the investigator.
排除标准
- •Serious and significant progressive, unstable, or uncontrolled clinical condition(s).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition.
- •Clinical condition(s) representing a contraindication to blood draws.
- •Any behavioural or cognitive impairment or psychiatric disease.
- •Acute disease and/or fever at the time of enrollment.
- •Individuals with known or suspected HIV infection or HIV-related disease, with history of an autoimmune disorder or any other known or suspected impairment/alteration of the immune system, or under immunosuppressive therapy.
- •Receipt of immunoglobulins and/or any blood products or plasma derivatives, during the period starting 3 months before each study visit.
研究组 & 干预措施
H06_01TP Study_Infants_Selected dose
Infants who received 3 doses of the altSonflex1-2-3 vaccine on Day 1, Day 85, and Day 253 in the H06_01TP parent study.
干预措施: AltSonflex1-2-3 (Biological)
H06_01TP Study_ ST2_Infants_Control
Infants who received 2 doses of the Menveo vaccine on Day 1 and Day 85, and 1 dose of the Infanrix hexa vaccine on Day 281 in the H06_01TP parent study.
干预措施: Menveo (Biological)
H06_01TP Study_ ST2_Infants_Control
Infants who received 2 doses of the Menveo vaccine on Day 1 and Day 85, and 1 dose of the Infanrix hexa vaccine on Day 281 in the H06_01TP parent study.
干预措施: Infanrix hexa (Biological)
H06_02TP Study_Infants_Selected dose
Infants who received 2 doses of the altSonflex1-2-3 vaccine on Day 1 and Day 169 in the H06_02TP parent study.
干预措施: AltSonflex1-2-3 (Biological)
H06_02TP Study_ Infants_Control
Infants who received 1 dose of the TYPHIBEV vaccine on Day 1 and 1 dose of the Infanrix hexa vaccine on Day 169 in the H06_02TP parent study.
干预措施: Infanrix hexa (Biological)
H06_02TP Study_ Infants_Control
Infants who received 1 dose of the TYPHIBEV vaccine on Day 1 and 1 dose of the Infanrix hexa vaccine on Day 169 in the H06_02TP parent study.
干预措施: TYPHIBEV (Biological)
结局指标
主要结局
Anti-serotype specific Shigella lipopolysaccharide (LPS)/O-antigen (OAg) serum immunoglobulin G (IgG), as measured by GVGH enzyme-linked immunosorbent assay . (ELISA)
时间窗: At Visit 1 of the current study (12 months after last vaccination in the parent studies)
S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes will be tested.
Anti-serotype specific Shigella LPS/OAg serum IgG, as measured by GVGH ELISA
时间窗: At Visit 3 of the current study (36 months after last vaccination in the parent studies)
S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes will be tested.
Anti-serotype specific Shigella LPS/OAg serum IgG, as measured by GVGH ELISA
时间窗: At Visit 2 of the current study (24 months after last vaccination in the parent studies)
S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes will be tested.
次要结局
未报告次要终点