Evidence map›Paper›PMID 38115002›Full record

ArticleMalaria journal2023

Can incorporating genotyping data into efficacy estimators improve efficiency of early phase malaria vaccine trials?

Gail E Potter, Viviane Callier, Biraj Shrestha, Sudhaunshu Joshi, Ankit Dwivedi, Joana C Silva, Matthew B Laurens, Dean A Follmann, Gregory A Deye

3 registry-linked trialsOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Malaria journal, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 35% of its field
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)
NCT02143934 phase4completednot on this map

Host and Parasites Factors Contributing to Risk of Plasmodium Re-infection and Morbidity in Elementary School Children in Maprik, East Sepik Province

TypeinterventionalSponsorPapua New Guinea Institute of Medical ResearchRan2009 to 2014Enrolled524ConditionsPlasmodium Vivax Infection, Plasmodium Vivax Clinical Episode, Plasmodium Falciparum Infection, Plasmodium Falciparum Clinical EpisodeArmsPrimaquine, Placebo, Chloroquine, Artemether Lumefantrine
NCT02663700 phase1completednot on this map

Dose Escalation Study of Sanaria's Irradiated Sporozoite Vaccine (PFSPZ Vaccine), Followed by a Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of PfSPZ Vaccine in Malaria-Experienced Adults in Burkina Faso

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2016 to 2018Enrolled112ConditionsPlasmodium Falciparum InfectionArmsArtesunate, PfSPZ Vaccine, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 1 country.

Gail E PotterBiostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA. gail.potter@nih.gov.
Viviane CallierClinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.
Biraj ShresthaCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.
Sudhaunshu JoshiCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.
Ankit DwivediInstitute for Genomic Sciences, University of Maryland School of Medicine, Baltimore, MD, USA.
Joana C SilvaInstitute for Genomic Sciences, University of Maryland School of Medicine, Baltimore, MD, USA.
Matthew B LaurensCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.
Dean A FollmannBiostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.
Gregory A DeyeDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.
University of Maryland, Baltimore · USNational Institutes of Health · USAstraZeneca (United States) · USFrederick National Laboratory for Cancer Research · US

Funding

Genome-wide sieve analysis and immunological validation to identify targets of protective efficacy in field trials of a whole-organism malaria vaccineR01AI141900 · NIAID · UNIVERSITY OF MARYLAND BALTIMORE · PI CARNEIRO DA SILVA, JOANA · 2019 to 2023
$3.9M
Safety and efficacy of PfSPZ malaria vaccine in malaria-exposed adultsU01AI112367 · NIAID · UNIVERSITY OF MARYLAND BALTIMORE · PI LAURENS, MATTHEW BRENT · 2015 to 2018
$2.8M
NIAID NIH HHS R01 AI141900NIAID NIH HHS U01 AI112367NIH HHS HHSN261201500003INIH HHS U01AI112367
6 · The paper itself

Abstract

backgroundEarly phase malaria vaccine field trials typically measure malaria infection by PCR or thick blood smear microscopy performed on serially sampled blood. Vaccine efficacy (VE) is the proportion reduction in an endpoint due to vaccination and is often calculated as VE

methodsPower of VE

resultsIn the trial of RTS,S vaccine, a significantly reduced number of clones at first infection was observed, but this was not the case in trials of PfSPZ Vaccine or primaquine, although the PfSPZ trial lacked power to show a reduction. Resampling smaller data sets from the large RTS,S trial to simulate phase 2 trials showed modest power gains from VE

conclusionsThe power gain from the genotyping methods depends on the context. Because input parameters for early phase power calculations are often uncertain, these estimators are not recommended as primary endpoints for small trials unless supported by targeted data analysis. TRIAL REGISTRATIONS: NCT00866619, NCT02663700, NCT02143934.

Indexed as

AntimalarialsMalariaMalaria, FalciparumMalaria VaccinesAdultArtemetherArtemether, Lumefantrine Drug CombinationChildClinical Trials as TopicGenotypeHumansInfantPrimaquineAntimalarialsArtemetherArtemether, Lumefantrine Drug CombinationMalaria VaccinesPrimaquineCloneEarly phaseEfficacyEfficiencyGenotypingMolecular endpointsMolecular force of infectionTrial efficiencyVaccine efficacy

Identifiers

PMID38115002
PMCPMC10729369
OpenAlexW4389935195

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.