NCT07036159招募中2 期
A Phase 2a, Open Label, Randomized, Interventional Study to Assess the Safety and Immunogenicity of Alternative Vaccination Regimens and Reduced Antigen Doses of RTS,S/AS01E Vaccine in Healthy Children Aged 5-60 Months in a Malaria-endemic Area
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Geometric Mean Concentrations (GMCs) of anti-NANP immunoglobulin G (IgG) antibodies
研究概览
简要总结
The purpose of this study is to evaluate the safety and immunogenicity of reduced antigen doses and alternative vaccination regimes for RTS,S/AS01E in healthy children aged 5-60 months in a malaria-endemic area.
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
Open label
入排标准
- 年龄范围
- 5 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female participants aged 5 to 60 months at the time of the first vaccination, who have previously completed the World Health Organization (WHO) Expanded Programme on Immunization (EPI) vaccinations or for younger infants have received all required vaccinations at point of recruitment according to the schedule for the country where the study is conducted.
- •Participants' parent(s)/Legally Acceptable Representative(s) (LAR), in the opinion of the investigator, can and will comply with the requirements of the protocol (eg, completion of the diaries, returning for follow-up visits).
- •Written or witnessed/thumb-printed informed consent obtained from the participant's parent(s)/LAR prior to performance of any study-specific procedure.
- •Healthy, as established by medical history and clinical examination.
- •Negative for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV).
- •With hemoglobin levels >8 g/dL.
- •Born after a gestation period of ≥37 weeks.
排除标准
- •Progressive, unstable, or uncontrolled clinical conditions.
- •History (known or suspected) of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •Clinical conditions representing a contraindication to IM vaccination or blood draws.
- •Any behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the study.
- •Recurrent history of or uncontrolled neurological disorders or seizures.
- •Undernutrition, defined as WHO Z-score less than -2 standard deviation.
- •Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant as a result of participation in the study, for example, any major congenital defects.
- •Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination and medical history.
- •Administration of long-acting immune-modifying drugs (eg, infliximab) during the study period starting 3 months before the first dose of study vaccine or planned administration during the study period.
- •Prior receipt of a malaria vaccine (registered or experimental).
- •Use of any investigational or non-registered product (drug, vaccine, or medical device)* other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day -30 to Day 1), or planned use during the study period.
- •*Use of herbs and traditional treatments is not considered an exclusion criterion.
- •Planned administration of a vaccine not foreseen by the study protocol or the country EPI in the period starting 14 days before each dose and ending 28 days after the last dose of study vaccine administration*, with the exception of flu vaccines and vaccines administered as part of a public health vaccination campaign*.
- •*If emergency mass vaccination for an unforeseen public health threat (eg, a pandemic) is organized by public health authorities outside the routine immunization program, the time period described above can be reduced, provided the vaccination is used according to the local governmental recommendations and the Sponsor is notified.
- •Under such circumstances, a participant may be considered eligible for study enrollment and/or study vaccine administration after the appropriate window for delay has passed, if the participant is confirmed to be eligible after inclusion/exclusion criteria have been re checked.
- •Administration of immunoglobulins and/or any blood products or plasma derivatives, or bone marrow transplantation, during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.
- •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine dose or planned administration during the study period. For corticosteroids, this means prednisone ≥0.5 mg/kg/day or 20 mg/day, whichever is the maximum dose for pediatric participants. Inhaled and topical steroids are allowed.
- •Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug or invasive medical device).
- •Any study personnel's immediate dependents, family, or household members.
- •Child in care.
研究组 & 干预措施
Groups 4 and 5
Experimental
Participants receive 3 doses of RTS,S/AS01E vaccine on Day 1, Month 1, and Month 7.
干预措施: RTS,S/AS01E vaccine (Biological)
Groups 1 to 3
Experimental
Participants receive 3 doses of RTS,S/AS01E vaccine on Day 1, Month 1, and Month 2.
干预措施: RTS,S/AS01E vaccine (Biological)
Groups 6 and 7
Experimental
Participants receive 3 doses of RTS,S/AS01E vaccine on Day 1, Month 2, and Month 7.
干预措施: RTS,S/AS01E vaccine (Biological)
结局指标
主要结局
Geometric Mean Concentrations (GMCs) of anti-NANP immunoglobulin G (IgG) antibodies
时间窗: 12 months post-Dose 3 (Month 14 for Groups 1 to 3 and Month 19 for Groups 4 and 5 and Groups 6 and 7)
次要结局
- Area under the curve (AUC) of anti-NANP IgG antibodies(At Month 7 and 19)
- GMC of anti-NANP IgG antibodies(At Month 0, 1, 2, 3, 7, 8, 14, and 19)
- Number of participants with a greater than or equal to (>=) 2-fold and a (>=) 4-fold increase from pre-Dose 1 in IgG antibody concentration(At Month 0, 1, 2, 3, 7, 8, 14, and 19)
- Number of participants with solicited administration site events(Up to 7 days after each vaccine administration (vaccine administered on Day 1, Month 1, Month 2, and Month 7))
- Number of participants with solicited systemic events(Up to 7 days after each vaccine administration (vaccine administered on Day 1, Month 1, Month 2, and Month 7))
- Number of participants with unsolicited adverse events (AEs)(Within 30 days after each study vaccine administration (vaccine administered on Day 1, Month 1, Month 2, and Month 7))
- Number of participants with serious adverse events (SAEs)(From first study vaccine administration (Day 1) to the end of the study (Month 19))
- Number of participants with SAEs(From first study vaccine administration (Day 1) to 12 months after the last study vaccine administration (Month 14 for Groups 1 to 3 and Month 19 for Groups 4 and 5 and Groups 6 and 7))
- Number of participants with adverse events of special interest (AESIs)(Up to 7 days after each vaccine administration (vaccine administered on Day 1, Month 1, Month 2, and Month 7))
- Number of participants with AEs/SAEs leading to withdrawal from the study and/or discontinuation of study vaccine(From first study vaccine administration (Day 1) to the end of the study (Month 19))
- GMC of anti-hepatitis B surface antigens (HBs) antibody concentrations (IgG)(At Month 0, 1, 2, 3, 7, 8, 14, and 19)
- Number of participants achieving anti-HBs IgG levels above 6.2 International Units per liter (IU/L) and 10.0 IU/L(At Month 0, 1, 2, 3, 7, 8, 14, and 19)
- Geometric mean fold increase over pre-Dose 1 for anti-HBs IgG(At Month 0, 1, 2, 3, 7, 8, 14, and 19)
研究者
研究点 (1)
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