Perennial Malaria Chemoprevention in the Malaria Vaccine Era
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 1,290
- 试验地点
- 1
- 主要终点
- Incidence of symptomatic malaria
研究概览
简要总结
Malaria remains a major cause of pediatric deaths and morbidity in Africa. An affordable malaria vaccine, R21, is being deployed in Uganda and other African countries with high malaria transmission, but efficacy is incomplete and wanes rapidly, and R21 does not provide protection until infants complete the primary vaccination series, or ~9 months of age. The goal of this study is to see whether combining R21 vaccination with two novel perennial malaria chemoprevention regimens can enhance protection against malaria compared with R21 alone. This study will take place at Masafu General Hospital (MGH) in Busia District, a rural area in Southeastern Uganda bordering Lake Victoria.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 10 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Residency in Busia District, Uganda
- •Provision of informed consent by the parent/guardian for her child
- •Agreement to come to the study clinic for any febrile episode or other illness and avoid, where possible, medications given outside the study protocol
排除标准
- •Intention of permanently moving outside Busia district during the study period
- •Active medical problem requiring inpatient evaluation or chronic medical condition requiring frequent medical attention at the time of screening
- •Evidence of sickle cell disease (Hemoglobin SS genotype)
- •Biological mother known to be HIV positive
研究组 & 干预措施
PMC-SPAQ
Perennial malaria chemoprevention with sulfadoxine-pyrimethamine + amodiaquine (SPAQ) given at Expanded Program of Immunization (EPI) visits (8 doses of SPAQ at 2.5, 3.5, 6, 7, 8, 9, 12, and 18 months of age).
Participants will also receive DP placebo along with active SPAQ. Placebo with an identical appearance to DP active drug will be provided by its manufacturer.
干预措施: Dihydroartemisinin Piperaquine Placebo (Drug)
PMC-Placebo
Placebo given at Expanded Program of Immunization (EPI) visits (8 doses of placebo at 2.5, 3.5, 6, 7, 8, 9, 12, and 18 months of age).
Participants will receive DP placebo plus SPAQ placebo. Placebos with an identical appearance to either DP or SPAQ active drugs will be provided by their manufacturers.
干预措施: Dihydroartemisinin Piperaquine Placebo (Drug)
PMC-Placebo
Placebo given at Expanded Program of Immunization (EPI) visits (8 doses of placebo at 2.5, 3.5, 6, 7, 8, 9, 12, and 18 months of age).
Participants will receive DP placebo plus SPAQ placebo. Placebos with an identical appearance to either DP or SPAQ active drugs will be provided by their manufacturers.
干预措施: Sulfadoxine pyrimethamine + Amodiaquine placebo (Drug)
PMC-SPAQ
Perennial malaria chemoprevention with sulfadoxine-pyrimethamine + amodiaquine (SPAQ) given at Expanded Program of Immunization (EPI) visits (8 doses of SPAQ at 2.5, 3.5, 6, 7, 8, 9, 12, and 18 months of age).
Participants will also receive DP placebo along with active SPAQ. Placebo with an identical appearance to DP active drug will be provided by its manufacturer.
干预措施: Sulfadoxine pyrimethamine + Amodiaquine (Drug)
PMC-DP
Perennial malaria chemoprevention with dihydroartemisinin-piperaquine (DP) given at Expanded Program of Immunization (EPI) visits (8 doses of DP at 2.5, 3.5, 6, 7, 8, 9, 12, and 18 months of age).
Participants will also receive SPAQ placebo along with active DP. Placebo with an identical appearance to SPAQ active drug will be provided by its manufacturer.
干预措施: Dihydroartemisinin Piperaquine (Drug)
PMC-DP
Perennial malaria chemoprevention with dihydroartemisinin-piperaquine (DP) given at Expanded Program of Immunization (EPI) visits (8 doses of DP at 2.5, 3.5, 6, 7, 8, 9, 12, and 18 months of age).
Participants will also receive SPAQ placebo along with active DP. Placebo with an identical appearance to SPAQ active drug will be provided by its manufacturer.
干预措施: Sulfadoxine pyrimethamine + Amodiaquine placebo (Drug)
结局指标
主要结局
Incidence of symptomatic malaria
时间窗: 2.5 months to 60 months of age
The incidence of symptomatic malaria is defined as the number of incident episodes of malaria requiring treatment per time at risk. Treatments within 14 days of a prior episode are not considered incident events.
次要结局
未报告次要终点
研究者
Prasanna Jagannathan
Associate Professor of Medicine
Stanford University