RTSS Vaccine and PBO Net Impact on Malaria Infection and Transmission in Malawi
NCT ID: NCT04327440
Last Updated: 2020-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
3000 participants
OBSERVATIONAL
2020-02-04
2024-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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
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.
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.
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
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
7 Months
10 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kamuzu University of Health Sciences
OTHER
University of Maryland, College Park
OTHER
Boston University
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Michigan State University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Terrie Taylor
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Malawi College of Medicine
Blantyre, , Malawi
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Don P Mathanga, MBBS, PhD
Role: primary
Peter AM Ntenda, PhD
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
00002662
Identifier Type: -
Identifier Source: org_study_id