跳至主要内容
临床试验/NCT04327440
NCT04327440已完成不适用

Combined Effects of RTS,S Vaccination and PBO Nets on Malaria Infection and Transmission in Malawi

Michigan State University1 个研究点 分布在 1 个国家目标入组 1,691 人开始时间: 2020年2月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,691
试验地点
1
主要终点
Anopheles species abundance

研究概览

简要总结

The overall goal of this study is to assess the impact of RTS,S (malaria) vaccination and PBO nets on malaria infection and transmission, independently and how they interact when they are introduced together.

The specific objectives for the study are as follows:

  1. To estimate the impact of PBO nets and RTS,S vaccine on Plasmodium infection prevalence and transmission, independently and how they interact when they are introduced together in Malawi (Phase 1).
  2. To assess the feasibility of evaluating the impact of RTS,S vaccine and PBO nets independently in a larger scale future study.

详细描述

Introduction

The decline in malaria incidence has stalled globally and incidence is increasing in some high transmission settings of sub-Saharan Africa, including Malawi. The situation is worsening despite the scale-up of previously effective interventions, raising concerns that the impact of current malaria control and prevention strategies maybe compromised.

Problem: There is an urgent need for innovative approaches to malaria control and Malawi is currently positioned to assess two of the most promising new interventions. The Malawi Ministry of Health (MOH) is launching large scale projects to evaluate a new formulation of insecticide-treated bed nets with a chemical synergist, piperonyl butoxide (PBO), designed to enhance the insecticidal effect of pyrethroids and the new malaria vaccine RTS,S (RTS,S). In an effort to gain the most information from these, interventions Malawi's National Malaria Control Programme (NMCP) have invited the Malawi International Center for Excellence in Malaria Research (ICEMR) to evaluate the effectiveness of the two interventions (alone and in combination) on malaria prevalence and transmission.

Objective

In this proposed implementation study, we propose to assess the impact of PBO nets and RTS,S vaccine on Plasmodium infection prevalence and transmission.

Study type and methodology: We will enroll children in a prospective cohort study in which the follow-up will be at the 2nd, 4th, and 6th month. We are selecting two health center catchment areas: one in which both RTS,S and PBO nets are available through the government health system and one in which there is no RTS,S vaccine available and standard long-lasting insecticide-treated nets (LLINS) have been distributed through the public section. At each visit, we will collect specimens to identify malaria infection and detect gametocyte infections. We will also collect and analyze mosquitoes from 100 households in both catchment areas to provide an entomological evidence of the force of infection. Children in households that are scheduled to receive both PBO nets and RTS,S vaccine will be compared to children in households that are not scheduled to receive either of these interventions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
7 Months 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 7 to 18 months of age (age-eligible for at least 3 doses of RTS,S doses) OR being one of not more than two children living in the household of an enrolled age-eligible child and being >18 mos and < 10 years of age.
  • Not on cotrimoxazole prophylaxis for HIV infection
  • Weight >5 kg
  • Permanent residence of Health Centre (HC) catchment area
  • Residence within 10 km from the HC
  • Written informed consent from parent/guardian for the child to participate in the study

排除标准

  • Non-residents of the catchment area and visitors to the study area will be excluded because the study requires follow-up for at least 6 months and access to interventions such as conventional, PBO nets and malaria vaccination.

研究组 & 干预措施

Nyambi, rainy season

250 children of age-eligible for RTS,S vaccine (7-18 months) 500 siblings (>18 months, < 10 years of age)

The duration of the cohort is six months.

干预措施: RTS,S/AS01 malaria vaccine (Biological)

Nyambi, rainy season

250 children of age-eligible for RTS,S vaccine (7-18 months) 500 siblings (>18 months, < 10 years of age)

The duration of the cohort is six months.

干预措施: PBO bed nets (Other)

Nyambi, dry season

250 children of age-eligible for RTS,S vaccine (7-18 months) 500 siblings (>18 months, < 10 years of age)

The duration of the cohort is six months.

干预措施: RTS,S/AS01 malaria vaccine (Biological)

Nyambi, dry season

250 children of age-eligible for RTS,S vaccine (7-18 months) 500 siblings (>18 months, < 10 years of age)

The duration of the cohort is six months.

干预措施: PBO bed nets (Other)

Kalembo, rainy season

250 children of age-eligible for RTS,S vaccine (7-18 months) 500 siblings (>18 months, < 10 years of age)

The duration of the cohort is six months.

Kalembo, dry season

250 children of age-eligible for RTS,S vaccine (7-18 months) 500 siblings (>18 months, < 10 years of age)

The duration of the cohort is six months.

结局指标

主要结局

Anopheles species abundance

时间窗: 6 months/cohort, 4 cohorts in Phase 1

Comparison of Anopheles captured in households with PBO nets compared to household with conventional nets

Malaria infection prevalence

时间窗: 6 months/cohort, 4 cohorts in Phase 1

Comparison of malaria infection prevalence in RTS/S cohorts compared to cohorts not exposed to RTS,S

次要结局

  • Gametocyte prevalence(6 months/cohort, 4 cohorts)
  • Anopheles gravidity rates(6 months/cohort, 4 cohorts)
  • Net usage(6 months/cohort, 4 cohorts)
  • Serological markers of immunity and exposure(6 months/cohort, 4 cohorts)
  • Anopheles sporozoite rates(6 months/cohort, 4 cohorts)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Terrie Taylor

Professor

Michigan State University

研究点 (1)

Loading locations...

相似试验