Evidence map›Paper›PMID 37790581›Full record

ArticleResearch square2023

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 · greenAbstract readPreprint
PubMed Full text at PMC Publisher
In one paragraph

Article in Research square, 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. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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)
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

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

Gail E PotterBiostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health.
Viviane CallierClinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research.
Biraj ShresthaMalaria Research Program, University of Maryland.
Sudhaunshu JoshiMalaria Research Program, University of Maryland.
Ankit DwivediInstitute for Genomic Sciences, University of Maryland School of Medicine.
Joana C SilvaInstitute for Genomic Sciences and Department of Microbiology & Immunology, University of Maryland School of Medicine.
Matthew B LaurensCenter for Vaccine Development and Global Health, University of Maryland School of Medicine.
Dean A FollmannBiostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health.
Gregory A DeyeDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health.
National Institutes of Health · USUniversity of Maryland, Baltimore · USFrederick National Laboratory for Cancer Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Early 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 Methods: We used simulations and analytic derivations to compare power of these methods to Results: The RTS,S vaccine significantly reduced the number of clones at first infection, but PfSPZ vaccine and primaquine did not. Resampling smaller data sets from the large RTS,S trial to simulate phase 2 trials showed modest power gains from Conclusions: The power gain from the genotyping methods depends on the context. Because input parameters for early phase power calculations are often uncertain, we recommend against these estimators as primary endpoints for small trials unless supported by targeted data analysis. Trial registrations: NCT00866619, NCT02663700, NCT02143934.

Indexed as

cloneearly phaseefficacyefficiencygenotypingmolecular endpointsmolecular force of infectiontrial efficiencyVaccine efficacy

Identifiers

PMID37790581
PMCPMC10543529
OpenAlexW4386950704

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.