Evidence map›Paper›PMID 28216244›Full record

Trial reportThe Lancet. Infectious diseases2017

Safety and efficacy of PfSPZ Vaccine against Plasmodium falciparum via direct venous inoculation in healthy malaria-exposed adults in Mali: a randomised, double-blind phase 1 trial.

Mahamadou S Sissoko, Sara A Healy, Abdoulaye Katile, Freda Omaswa, Irfan Zaidi, Erin E Gabriel, Bourama Kamate, Yacouba Samake, Merepen A Guindo, Amagana Dolo and 26 more

2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Infectious diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 192 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
192citing papers in PubMed, 4 pooled it
35.2field-weighted citation impact, top 1% 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.

NCT03510481 phase1completednot on this mapstarted 2018, after this paper: background citation

Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety, Immunogenicity, and Protective Efficacy of Two Regimens of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Natural Transmission Season in Healthy African Adults in Mali

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2018 to 2020Enrolled478ConditionsMalariaArmsPfSPZ Vaccine, Normal Saline, artemether 20mg/lumefantrine 120mg (AL)
NCT03989102 phase2completednot on this mapstarted 2019, after this paper: background citation

Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety, Immunogenicity, and Protective Efficacy of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Malaria Transmission Season in Healthy African Adult Women of Childbearing Potential in Mali

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2019 to 2023Enrolled324ConditionsMalariaArmsPfSPZ Vaccine, Normal Saline
3 · Its place in the literature

Who cites it

192 citing papers in PubMed, 4 syntheses or guidelines pooled it, 315 citations in OpenAlex.

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  8. Genotypic analysis of RTS,S/AS01The Lancet. Infectious diseases · 2024
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  18. Increase of Dose Associated With Decrease in Protection Against Controlled Human Malaria Infection by PfSPZ Vaccine in Tanzanian Adults.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2020
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132 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

36 authors at 3 institutions in 1 country.

Mahamadou S SissokoMalaria Research and Training Center, Mali National Institute of Allergy and Infectious Diseases International Centers for Excellence in Research, University of Science, Techniques and Technologies of Bamako, Bamako, Mali.
Sara A HealyLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Abdoulaye KatileMalaria Research and Training Center, Mali National Institute of Allergy and Infectious Diseases International Centers for Excellence in Research, University of Science, Techniques and Technologies of Bamako, Bamako, Mali.
Freda OmaswaSanaria, Rockville, MD, USA.
Irfan ZaidiLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Erin E GabrielBiostatistical Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Bourama KamateMalaria Research and Training Center, Mali National Institute of Allergy and Infectious Diseases International Centers for Excellence in Research, University of Science, Techniques and Technologies of Bamako, Bamako, Mali.
Yacouba SamakeMalaria Research and Training Center, Mali National Institute of Allergy and Infectious Diseases International Centers for Excellence in Research, University of Science, Techniques and Technologies of Bamako, Bamako, Mali.
Merepen A GuindoMalaria Research and Training Center, Mali National Institute of Allergy and Infectious Diseases International Centers for Excellence in Research, University of Science, Techniques and Technologies of Bamako, Bamako, Mali.
Amagana DoloMalaria Research and Training Center, Mali National Institute of Allergy and Infectious Diseases International Centers for Excellence in Research, University of Science, Techniques and Technologies of Bamako, Bamako, Mali.
Amadou NiangalyMalaria Research and Training Center, Mali National Institute of Allergy and Infectious Diseases International Centers for Excellence in Research, University of Science, Techniques and Technologies of Bamako, Bamako, Mali.
Karamoko NiaréMalaria Research and Training Center, Mali National Institute of Allergy and Infectious Diseases International Centers for Excellence in Research, University of Science, Techniques and Technologies of Bamako, Bamako, Mali.
Amatigue ZeguimeMalaria Research and Training Center, Mali National Institute of Allergy and Infectious Diseases International Centers for Excellence in Research, University of Science, Techniques and Technologies of Bamako, Bamako, Mali.
Kourane SissokoMalaria Research and Training Center, Mali National Institute of Allergy and Infectious Diseases International Centers for Excellence in Research, University of Science, Techniques and Technologies of Bamako, Bamako, Mali.
Hama DialloMalaria Research and Training Center, Mali National Institute of Allergy and Infectious Diseases International Centers for Excellence in Research, University of Science, Techniques and Technologies of Bamako, Bamako, Mali.
Ismaila TheraMalaria Research and Training Center, Mali National Institute of Allergy and Infectious Diseases International Centers for Excellence in Research, University of Science, Techniques and Technologies of Bamako, Bamako, Mali.
Kelly DingLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Michael P FayBiostatistical Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Elise M O'ConnellLaboratory of Parasitic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Thomas B NutmanLaboratory of Parasitic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Sharon Wong-MaddenLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Tooba MurshedkarSanaria, Rockville, MD, USA.
Adam J RubenSanaria, Rockville, MD, USA.
Minglin LiSanaria, Rockville, MD, USA.
Yonas AbebeSanaria, Rockville, MD, USA.
Anita ManojSanaria, Rockville, MD, USA.
Anusha GunasekeraSanaria, Rockville, MD, USA.
Sumana ChakravartySanaria, Rockville, MD, USA.
B Kim Lee SimSanaria, Rockville, MD, USA.
Peter F BillingsleySanaria, Rockville, MD, USA.
Eric R JamesSanaria, Rockville, MD, USA.
Michael WaltherLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Thomas L RichieSanaria, Rockville, MD, USA.
Stephen L HoffmanSanaria, Rockville, MD, USA.
Ogobara DoumboMalaria Research and Training Center, Mali National Institute of Allergy and Infectious Diseases International Centers for Excellence in Research, University of Science, Techniques and Technologies of Bamako, Bamako, Mali.
Patrick E DuffyLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA. Electronic address: patrick.duffy@nih.gov.
Sanaria · USNational Institute of Allergy and Infectious Diseases · USNational Institutes of Health · US

Funding

Plasmodium Falciparum Whole Sporozoite Malaria VaccineR44AI055229 · NIAID · SANARIA, INC. · PI HOFFMAN, STEPHEN LEV · 2005 to 2015
$10.0M
Pre-erythrocytic malaria vaccines: Discovery and Clinical DevelopmentZIAAI001135 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI DUFFY, PATRICK · 2010 to 2025
$6.4M
Assessment of whole organism vaccinations in Malian AdultsZIAAI001170 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI DUFFY, PATRICK · 2012 to 2024
$4.8M
Mali International Center for Excellence in Research: FilariasisZIAAI001063 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI NUTMAN, THOMAS · 2009 to 2025
$3.2M
Biomarkers and host-parasite interactions in neurocysticercosis and other parasitic infectionsZIAAI001234 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI NUTMAN, THOMAS · 2018 to 2025
$2.5M
Intramural NIH HHS ZIA AI001170NIAID NIH HHS R44 AI055229
6 · The paper itself

Abstract

backgroundPlasmodium falciparum sporozite (PfSPZ) Vaccine is a metabolically active, non-replicating, whole malaria sporozoite vaccine that has been reported to be safe and protective against P falciparum controlled human malaria infection in malaria-naive individuals. We aimed to assess the safety and protective efficacy of PfSPZ Vaccine against naturally acquired P falciparum in malaria-experienced adults in Mali.

methodsAfter an open-label dose-escalation study in a pilot safety cohort, we did a double-blind, randomised, placebo-controlled trial based in Donéguébougou and surrounding villages in Mali. We recruited 18-35-year-old healthy adults who were randomly assigned (1:1) in a double-blind manner, with stratification by village and block randomisation, to receive either five doses of 2·7 × 10

findingsBetween Jan 18 and Feb 24, 2014, we enrolled 93 participants into the main study cohort with 46 participants assigned PfSPZ Vaccine and 47 assigned placebo, all of whom were evaluable for safety. We detected no significant differences in local or systemic adverse events or laboratory abnormalities between the PfSPZ Vaccine and placebo groups, and only grade 1 (mild) local or systemic adverse events occurred in both groups. The most common solicited systemic adverse event in the vaccine and placebo groups was headache (three [7%] people in the vaccine group vs four [9%] in the placebo group) followed by fatigue (one [2%] person in the placebo group), fever (one [2%] person in the placebo group), and myalgia (one [2%] person in each group). The exploratory efficacy analysis included 41 participants from the vaccine group and 40 from the placebo group. Of these participants, 37 (93%) from the placebo group and 27 (66%) from the vaccine group developed P falciparum infection. The hazard ratio for vaccine efficacy was 0·517 (95% CI 0·313-0·856) by time-to-infection analysis (log-rank p=0·01), and 0·712 (0·528-0·918) by proportional analysis (p=0·006).

interpretationPfSPZ Vaccine was well tolerated and safe. PfSPZ Vaccine showed significant protection in African adults against P falciparum infection throughout an entire malaria season.

fundingUS National Institutes of Health Intramural Research Program, Sanaria.

Indexed as

Immunization ScheduleAdolescentAdultAntimalarialsArtemetherArtemisininsDouble-Blind MethodEthanolaminesFemaleFluorenesHumansLumefantrineMalaria, FalciparumMaleMaliPlasmodium falciparumAntimalarialsArtemetherArtemisininsEthanolaminesFluorenesLumefantrine

Identifiers

PMID28216244
PMCPMC6803168
OpenAlexW2587907012

What OpenQuestion holds

Textmetadata
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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.