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RTSS Vaccine and PBO Net Impact on Malaria Infection and Transmission in Malawi

NCT04327440 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1691

Last updated 2026-01-13

No results posted yet for this study

Summary

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.

Conditions

  • Malaria, Malaria Vaccine, Insecticide-treated Bednets

Interventions

BIOLOGICAL

RTS,S/AS01 malaria vaccine

Malaria vaccine: RTS,S is a subunit vaccine that includes a portion of the circumsporozoite protein (CSP) co-expressed with Hepatitis B surface antigen combined with an adjuvant. The Phase 3 trial of three doses administered to 5-17-month-olds confirmed moderate protection, with overall efficacy estimates of 50.4% against clinical malaria and 34.8% against severe malaria after three doses. Efficacy, which waned over time, was marginally improved by boosting at 18 months. The European Medicines Agency adopted a positive scientific opinion of the vaccine for use outside of the European Union. The World Health Organization has created the Malaria Vaccine Implementation Program (MVIP) and selected Malawi as one of the sites to explore the feasibility, efficacy and safety of RTS,S vaccination in the context of routine use.

OTHER

PBO bed nets

PBO nets: The PBO nets represent a new formulation of insecticide-treated bed nets with a chemical synergist, piperonyl butoxide (PBO), designed to enhance the insecticidal effect of pyrethroids. They seem to be helpful in areas like Malawi where insecticide-resistance is increasing. PBO inhibits the enzyme that detoxifies the pyrethroid, allowing the pyrethroid to act on the mosquito. The impact of PBO net use was also detectable in key entomological measures including Anopheles density, sporozoite rate and entomological inoculation rates. Following these promising preliminary results in Tanzania, Malawi's National Malaria Control Program (NMCP) is piloting the use of PBO-nets iin one of our two study sites, presenting us with the opportunity to study the effectiveness of these nets in the context of real-world program setting

Sponsors & Collaborators

  • Kamuzu University of Health Sciences

    collaborator OTHER

  • University of Maryland, Baltimore

    collaborator OTHER

  • Boston University

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Michigan State University

    lead OTHER

Eligibility

Min Age
7 Months
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-04
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • Malawi

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04327440 on ClinicalTrials.gov