Malaria, Malaria Vaccine, Insecticide-treated Bednets Clinical Trial
Official title:
Combined Effects of RTS,S Vaccination and PBO Nets on Malaria Infection and Transmission in Malawi
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.
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.
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