Evidence map›Paper›PMID 39153490›Full record

Trial reportThe Lancet. Infectious diseases2024

Safety and efficacy of PfSPZ Vaccine against malaria in healthy adults and women anticipating pregnancy in Mali: two randomised, double-blind, placebo-controlled, phase 1 and 2 trials.

Halimatou Diawara, Sara A Healy, Agnes Mwakingwe-Omari, Djibrilla Issiaka, Aye Diallo, Seydou Traore, Ibrahim H Soumbounou, Santara Gaoussou, Irfan Zaidi, Almahamoudou Mahamar and 21 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IIClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Review
  7. Article
  8. Article
  9. Article
  10. Review
  11. Review
  12. Vaccine Distribution Logistics.Methods in molecular biology (Clifton, N.J.) · 2026
    Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article
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

31 authors.

Halimatou DiawaraMalaria Research and Training Center, University of Sciences, 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.
Agnes Mwakingwe-OmariLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Djibrilla IssiakaMalaria Research and Training Center, University of Sciences, Techniques, and Technologies of Bamako, Bamako, Mali.
Aye DialloLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Seydou TraoreMalaria Research and Training Center, University of Sciences, Techniques, and Technologies of Bamako, Bamako, Mali.
Ibrahim H SoumbounouMalaria Research and Training Center, University of Sciences, Techniques, and Technologies of Bamako, Bamako, Mali.
Santara GaoussouMalaria Research and Training Center, University of Sciences, Techniques, and Technologies of Bamako, Bamako, Mali.
Irfan ZaidiLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Almahamoudou MahamarMalaria Research and Training Center, University of Sciences, Techniques, and Technologies of Bamako, Bamako, Mali.
Oumar AttaherMalaria Research and Training Center, University of Sciences, Techniques, and Technologies of Bamako, Bamako, Mali.
Michal FriedLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Blair J WylieColumbia University Medical Center, Columbia University, New York, NY, USA.
Rathy MohanLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Viyada DoanLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Justin Y A DoritchamouLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Amagana DoloMalaria Research and Training Center, University of Sciences, Techniques, and Technologies of Bamako, Bamako, Mali.
Robert D MorrisonLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Jing WangClinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.
Zonghui HuBiostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Kelly M RauschLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Amatigue ZeguimeMalaria Research and Training Center, University of Sciences, Techniques, and Technologies of Bamako, Bamako, Mali.
Tooba MurshedkarSanaria, Rockville, MD, USA.
Natasha KcSanaria, Rockville, MD, USA.
B Kim Lee SimSanaria, Rockville, MD, USA.
Peter F BillingsleySanaria, Rockville, MD, USA.
Thomas L RichieSanaria, Rockville, MD, USA.
Stephen L HoffmanSanaria, Rockville, MD, USA.
Alassane DickoMalaria Research and Training Center, University of Sciences, 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.
PfSPZ Vaccine Study Team

Funding

WORK ORDER 126643 B539 EXPAND IC SUITE75N91019D00024 · NIAID · LEIDOS BIOMEDICAL RESEARCH, INC. · PI BRISCOE, LYNN · 2019 to 2025
$3932.6M
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
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 AI001170NCI NIH HHS 75N91019D00024NIAID NIH HHS R44 AI055229
6 · The paper itself

Abstract

backgroundPlasmodium falciparum parasitaemia during pregnancy causes maternal, fetal, and infant mortality. Poor pregnancy outcomes are related to blood-stage parasite sequestration and the ensuing inflammatory response in the placenta, which decreases over successive pregnancies. A radiation-attenuated, non-replicating, whole-organism vaccine based on P falciparum sporozoites (PfSPZ Vaccine) has shown efficacy at preventing infection in African adults. Here, we aimed to examine vaccine safety and efficacy of the PfSPZ Vaccine in adults and women who anticipated conception.

methodsTwo randomised, double-blind, placebo-controlled trials (phase 1 MLSPZV3 and phase 2 MLSPZV4) were conducted at a clinical research centre in Mali. MLSPZV3 included adults aged 18-35 years and MLSPZV4 included non-pregnant women aged 18-38 years who anticipated conception within a year of enrolment. In MLSPZV3, participants were stratified by village and randomly assigned (2:1) using block randomisation to receive three doses of 9 × 10

findingsParticipants were enrolled for vaccination during the onset of malaria seasons for two sequential studies conducted from 2018 to 2019 for MLSPZV3 and from 2019 to 2021 for MLSPZV4, with follow-up during malaria seasons across 2 years. In MLSPZV3, 478 adults were assessed for eligibility, of whom 220 were enrolled between May 30 and June 12, 2018, and then between Aug 13 and Aug 18, 2018, and 210 received dose one. 66 (96%) of 69 participants who received the 16-week schedule and 68 (97%) of 70 who received the 4-week schedule of the 9 × 10

interpretationPfSPZ Vaccine was safe and well tolerated in adults in Mali. The 9 × 10

fundingNational Institute of Allergy and Infectious Diseases, National Institutes of Health, and Sanaria.

Indexed as

Malaria, FalciparumMalaria VaccinesPlasmodium falciparumAdolescentAdultAntimalarialsDouble-Blind MethodFemaleHumansMaliParasitemiaPregnancyPregnancy Complications, ParasiticSporozoitesYoung AdultAntimalarialsMalaria Vaccines

Identifiers

PMID39153490
PMCPMC12117479

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.