Evidence map›Paper›PMID 32532234›Full record

Trial reportBMC public health2020

Environmental modifiers of RTS,S/AS01 malaria vaccine efficacy in Lilongwe, Malawi.

Griffin J Bell, Matthew S Loop, Tisungane Mvalo, Jonathan J Juliano, Innocent Mofolo, Portia Kamthunzi, Gerald Tegha, Marc Lievens, Jeffrey Bailey, Michael Emch and 1 more

Registry-linked trialAbstract readClinical Trial, Phase III
In one paragraph

Trial report in BMC public health, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00866619 (Efficacy of GSK Biologicals' Candidate Malaria Vaccine), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00866619 phase3completednot on this map

Efficacy of GSK Biologicals' Candidate Malaria Vaccine (257049) Against Malaria Disease Caused by P. Falciparum Infection in Infants and Children in Africa

TypeinterventionalSponsorGlaxoSmithKlineRan2009 to 2014Enrolled15,459ConditionsMalariaArmsMalaria Vaccine 257049, Meningococcal C Conjugate Vaccine, Cell-culture rabies vaccine, TritanrixHepB/Hib, Polio Sabin Oral Polio Vaccine (GSK)
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Pediatric Cerebral Malaria.Current tropical medicine reports · 2021
    Article
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Griffin J BellDepartment of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, 27599, USA. gjbell86@live.unc.edu.ORCID http://orcid.org/0000-0003-4367-135X
Matthew S LoopDepartment of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, 27599, USA.
Tisungane MvaloUniversity of North Carolina, Chapel Hill, NC, 27599, USA.
Jonathan J JulianoDivision of Infectious Diseases, School of Medicine, University of North Carolina, Chapel Hill, NC, 27599, USA.
Innocent MofoloUniversity of North Carolina, Chapel Hill, NC, 27599, USA.
Portia KamthunziUniversity of North Carolina, Chapel Hill, NC, 27599, USA.
Gerald TeghaUniversity of North Carolina Project Malawi, Lilongwe, Malawi.
Marc LievensGlaxoSmithKline (GSK), Wavre, Belgium.
Jeffrey BaileyDepartment of Pathology and Laboratory Medicine, Brown University, Providence, RI, 02912, USA.
Michael EmchDepartment of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, 27599, USA.
Irving HoffmanUniversity of North Carolina, Chapel Hill, NC, 27599, USA.

Funding

Impacts of Environment, Host Genetics and Antigen Diversity on Malaria Vaccine EfficacyR01AI137410 · NIAID · UNIV OF MASSACHUSETTS MED SCH WORCESTER · PI BAILEY, JEFFREY A., EMCH, MICHAEL · 2018 to 2023
$3.6M
NIAID NIH HHS R01 AI137410NIH HHS 1R01-AI137410-01
6 · The paper itself

Abstract

backgroundRTS,S/AS01 is the first vaccine against malaria to undergo pilot implementation, beginning in 2019 and vaccinating 360,000 children per year in Malawi, Ghana, and Kenya. The four-dose vaccine is given as a primary three-dose series with a fourth dose given approximately 18 months later. The efficacy of RTS,S/AS01 was variable among the 11 sites participating in the 2009-2014 phase III trial (MALARIA-055, NCT00866619), possibly due to differences in transmission intensity. However, a within-site examination of environmental factors related to transmission intensity and their impact on vaccine efficacy has yet to be conducted.

methodsWe implemented the phase III RTS,S/AS01 trial at the Malawi site, which enrolled 1578 infants (6-12 weeks) and children (5-17 months) living in the Lilongwe District in Central Malawi and followed them for 3 years between 2009 and 2014. A global positioning system survey and an ecological questionnaire were conducted to collect participant household locations and characteristics, while additional data on background malaria prevalence were obtained from a concurrent Malaria Transmission Intensity (MTI) survey. Negative binomial regression models were used to assess whether the efficacy of the vaccine varied by estimated background malaria prevalence, household roof type, or amount of nearby vegetation.

resultsVaccine efficacy did not significantly vary by estimated malaria prevalence or by roof type. However, increased vegetation cover was associated with an increase in the efficacy of the three-dose primary RTS,S/AS01 series in the 18 months before the fourth dose and a decrease in the efficacy of the primary vaccine series in the second 18 months following, if the fourth dose was not given. Vegetation cover did not alter the efficacy of the fourth dose in a statistically or practically significant manner.

conclusionsVegetation coverage in this study site might be a proxy for nearness to rivers or branching, shallow wetlands called "dambos" which could serve as breeding sites for mosquitoes. We observed statistically significant modification of the efficacy of RTS,S/AS01 by forest cover, suggesting that initial vaccine efficacy and the importance of the fourth dose varies based on ecological context.

trial registrationEfficacy of GSK Biologicals' Candidate Malaria Vaccine (257049) Against Malaria Disease Caused by P. falciparum Infection in Infants and Children in Africa. NCT00866619 prospectively registered 20 March 2009.

Indexed as

ChildEnvironmentFemaleGeographic Information SystemsHumansInfantMalaria, FalciparumMalaria VaccinesMalawiMalePlasmodium falciparumSpatial AnalysisSurveys and QuestionnairesVaccinationMalaria VaccinesAfricaHansen Forest coverMalariaMalawiRTS,S/AS01Spatial analysisVaccineVaccine trial

Identifiers

PMID32532234
PMCPMC7291743

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.