Evidence map›Paper›PMID 34801112›Full record

Trial reportThe Lancet. Infectious diseases2022

Safety and efficacy of a three-dose regimen of Plasmodium falciparum sporozoite vaccine in adults during an intense malaria transmission season in Mali: a randomised, controlled phase 1 trial.

Mahamadou S Sissoko, Sara A Healy, Abdoulaye Katile, Irfan Zaidi, Zonghui Hu, Bourama Kamate, Yacouba Samake, Kourane Sissoko, Agnes Mwakingwe-Omari, Jacquelyn Lane and 23 more

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

Trial report in The Lancet. Infectious diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03989102 (Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety, Immunogenicity, and Protective Efficacy of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites), which is not on this map. Cited by 60 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 1 pooled it
12.2field-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.

NCT03989102 phase2completednot on this map

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

60 citing papers in PubMed, 1 synthesis or guideline pooled it, 78 citations in OpenAlex.

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  5. Genotypic analysis of RTS,S/AS01The Lancet. Infectious diseases · 2024
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

33 authors at 5 institutions in 2 countries.

Mahamadou S SissokoMalaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of 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-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.
Irfan ZaidiLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Zonghui HuBiostatistical Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Bourama KamateMalaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.
Yacouba SamakeMalaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.
Kourane SissokoMalaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.
Agnes Mwakingwe-OmariLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA; Center for Vaccine Research, GlaxoSmithKline, Rockville, MD, USA.
Jacquelyn LaneLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Alemush ImeruLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Rathy MohanLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Ismaila TheraMalaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.
Cheick Oumar GuindoMalaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.
Amagana DoloMalaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.
Karamoko NiareMalaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.
Fanta KoïtaMalaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.
Amadou NiangalyMalaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.
Kelly M RauschMalaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.
Amatigue ZeguimeMalaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.
Merepen A GuindoMalaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of Bamako, Mali.
Aissatou BahLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA; Laboratory of Parasitic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Yonas AbebeSanaria, Rockville, MD, USA.
Eric R JamesSanaria, Rockville, MD, USA.
Anita ManojSanaria, Rockville, MD, USA.
Tooba MurshedkarSanaria, Rockville, MD, USA.
Natasha KcSanaria, Rockville, MD, USA; Protein Potential, Rockville, MD, USA.
B Kim Lee SimSanaria, Rockville, MD, USA; Protein Potential, Rockville, MD, USA.
Peter F BillingsleySanaria, Rockville, MD, USA.
Thomas L RichieSanaria, Rockville, MD, USA.
Stephen L HoffmanSanaria, Rockville, MD, USA.
Ogobara DoumboMalaria Research and Training Center, Mali-NIAID ICER, University of Science, Techniques and Technologies of 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.
Université des Sciences, des Techniques et des Technologies de Bamako · MLSanaria · USNational Institute of Allergy and Infectious Diseases · USNational Institutes of Health · USGlaxoSmithKline (United States) · US

Funding

Plasmodium Falciparum Whole Sporozoite Malaria VaccineR44AI055229 · NIAID · SANARIA, INC. · PI HOFFMAN, STEPHEN LEV · 2005 to 2015
$10.0M
Assessment of whole organism vaccinations in Malian AdultsZIAAI001170 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI DUFFY, PATRICK · 2012 to 2024
$4.8M
The Role of T Cell Regulatory Mechanisms in Protection from Severe MalariaZIAAI001147 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI DUFFY, PATRICK · 2011 to 2025
$2.3M
Intramural NIH HHS ZIA AI001147Intramural NIH HHS ZIA AI001170NIAID NIH HHS R44 AI055229
6 · The paper itself

Abstract

backgroundWHO recently approved a partially effective vaccine that reduces clinical malaria in children, but increased vaccine activity is required to pursue malaria elimination. A phase 1 clinical trial was done in Mali, west Africa, to assess the safety, immunogenicity, and protective efficacy of a three-dose regimen of Plasmodium falciparum sporozoite (PfSPZ) Vaccine (a metabolically active, non-replicating, whole malaria sporozoite vaccine) against homologous controlled human malaria infection (CHMI) and natural P falciparum infection.

methodsWe recruited healthy non-pregnant adults aged 18-50 years in Donéguébougou, Mali, and surrounding villages (Banambani, Toubana, Torodo, Sirababougou, Zorokoro) for an open-label, dose-escalation pilot study and, thereafter, a randomised, double-blind, placebo-controlled main trial. Pilot study participants were enrolled on an as-available basis to one group of CHMI infectivity controls and three staggered vaccine groups receiving: one dose of 4·5 × 10

findingsBetween Dec 20, 2015, and April 30, 2016, we enrolled 56 participants into the pilot study (five received the 4·5 × 10

interpretationA three-dose regimen of PfSPZ Vaccine was safe, well tolerated, and conferred 51% vaccine efficacy against intense natural P falciparum transmission, similar to 52% vaccine efficacy reported for a five-dose regimen in a previous trial.

fundingUS National Institute of Allergy and Infectious Diseases, National Institutes of Health, Sanaria. TRANSLATION: For the French translation of the abstract see Supplementary Materials section.

Indexed as

MalariaMalaria, FalciparumMalaria VaccinesAdolescentAdultAnimalsChildDouble-Blind MethodHumansMaliMiddle AgedPilot ProjectsPlasmodium falciparumSeasonsSporozoitesYoung AdultMalaria Vaccines

Identifiers

PMID34801112
PMCPMC8981424
OpenAlexW3211957940

What OpenQuestion holds

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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.