Immunogenicity of a Fractional Adult Dose of the Malaria Vaccine R21/Matrix-M - A Noninferiority Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 375
- 试验地点
- 4
- 主要终点
- The concentration of antibodies against Plasmodium falciparum circumsporozoite (anti-NANP total IgG antibody)
研究概览
简要总结
This is a single blind randomised controlled trial (Phase 3 trial). This study aims to assess whether a half-dose of the R21/Matrix-M malaria vaccine is as effective as the full dose in children and adults. The results will help optimize vaccine usage and improve malaria prevention strategies.
All participants will receive the same number of injections and will be randomly assigned to receive one of the followings:
- Group 1: Adults and adolescents receiving the standard adult vaccine dose: 10μg R21/50μg Matrix-M (n=125).
- Group 2: Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M: 10 dose vials with adaptor Preservative Free (n=125)
- Group 3: Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M: 10 dose vials with 2PE Preservative (n=125)
Clinical procedure for participants:
- Standardized symptom questionnaire
- Physical examination:
Weight, height, pulse, blood pressure, respiratory rate, tympanic temperature. Spleen and liver size will be recorded if palpable. Pregnancy test (for female of child bearing potential)
- Venous blood collection (Pre-vaccination) 3mL
- Vaccination
详细描述
This study was funded by Hanako Foundation. The grant reference number: 001/2026.
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
- Single (Investigator)
入排标准
- 年龄范围
- 14 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Residence in a study village for the study period, i.e. 12 months.
- •Age 14 years to 60 years.
- •Written informed consent/assent provided by participants (or a parent/guardian in case the participant is under 18 years old).
排除标准
- •Pregnancy, plan to get pregnant within one month of vaccination, or breastfeeding.
- •Acute illness requiring intervention.
- •A history of an adverse reaction to study vaccine.
- •Prior receipt of any other malaria vaccine.
- •Enrolment in another intervention trial in the last month.
- •Planned enrolment in another intervention trial in the coming 12 months.
- •Regular use of Immunomodulating drugs e.g, Steroid, Methotrexate, Immunotherapy etc. in the past month and/or planned for the coming 12 months.
研究组 & 干预措施
A half of the standard adult vaccine dose with adaptor Preservative Free
Adults and adolescents receiving a half of the standard adult vaccine dose with adaptor Preservative Free (n=125)
干预措施: 5μg R21/50μg Matrix-M with adaptor preservative free (Biological)
A half of the standard adult vaccine dose with 2PE Preservative
Adults and adolescents receiving a half of the standard adult vaccine dose with 2PE Preservative (n=125)
干预措施: 5μg R21/50μg Matrix-M with 2PE preservative (Biological)
The standard adult vaccine dose
Adults and adolescents receiving the standard adult vaccine dose
干预措施: 10μg R21/50μg Matrix-M (Biological)
结局指标
主要结局
The concentration of antibodies against Plasmodium falciparum circumsporozoite (anti-NANP total IgG antibody)
时间窗: One month after the completion of the third dose (at M3), and one month after the booster dose (at M12).
The concentration of antibodies against Plasmodium falciparum circumsporozoite (anti C-Term, and full length R21 total IgG antibody), in addition to total IgG against Hepatitis B surface antigen
时间窗: One month after the completion of the third dose (at M3), and one month after the booster dose (at M12).
次要结局
- Adverse event and severe adverse event reports for safety and tolerability assessment of the standard adult vaccine dose 10μg R21/50μg Matrix-M and a half of the standard adult dose 5μg R21/50μg Matrix-M(At Month 1, Month 2, Month 3, Month 11 and Month 12)
- Adverse event and severe adverse event reports for safety and tolerability assessment a half of the standard adult dose 5μg R21/50μg Matrix-M with 2PE preservative vs, without 2PE preservative.(At Month 1, Month 2, Month 3, Month 11 and Month 12)