Evidence map›Paper›PMID 35928033›Full record

ArticleEClinicalMedicine2022

PfSPZ-CVac malaria vaccine demonstrates safety among malaria-experienced adults: A randomized, controlled phase 1 trial.

Drissa Coulibaly, Abdoulaye K Kone, Karim Traore, Amadou Niangaly, Bourema Kouriba, Charles Arama, Amatigue Zeguime, Amagana Dolo, Kirsten E Lyke, Christopher V Plowe and 15 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in EClinicalMedicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02996695 (Safety, Tolerability, Immunogenicity and Protective Efficacy Against Naturally-Transmitted Malaria of Infectious, Cryopreserved Plasmodium Falciparum Sporozoites), which is not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
5.4field-weighted citation impact, top 4% 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.

NCT02996695 phase1completednot on this map

Safety, Tolerability, Immunogenicity and Protective Efficacy Against Naturally-Transmitted Malaria of Infectious, Cryopreserved Plasmodium Falciparum Sporozoites (PfSPZ Challenge) Administered by Direct Venous Inoculation Under Chloroquine Chemoprophylaxis (PfSPZ-CVac), in Malian Adults: A Randomized, Double Blind, Placebo-Controlled Trial

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2017 to 2018Enrolled62ConditionsPlasmodium Falciparum InfectionArmsArtesunate, Chloroquine, PfSPZ (NF54) Challenge, Placebo
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Vaccine Treatment and Evaluation Units: Why Support a "Ready Base" of Clinical Trial Sites?Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  5. From Yesterday to Tomorrow: How Vaccine Platforms Have Shaped the Vaccine and Treatment Evaluation Units.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  6. Review
  7. Review
  8. Article
  9. Review
  10. Article
  11. Review
  12. Review
  13. Article
  14. Malaria Vaccines: Progress to Date.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023
    Review
  15. Review
  16. Article
  17. Review
  18. Article
  19. Review
  20. Host-parasite interactions duringFrontiers in immunology · 2022
    Review
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

25 authors at 5 institutions in 2 countries.

Drissa CoulibalyMalaria Research and Training Center, University of Sciences, Techniques and Technologies, Bamako, Mali.
Abdoulaye K KoneMalaria Research and Training Center, University of Sciences, Techniques and Technologies, Bamako, Mali.
Karim TraoreMalaria Research and Training Center, University of Sciences, Techniques and Technologies, Bamako, Mali.
Amadou NiangalyMalaria Research and Training Center, University of Sciences, Techniques and Technologies, Bamako, Mali.
Bourema KouribaMalaria Research and Training Center, University of Sciences, Techniques and Technologies, Bamako, Mali.
Charles AramaMalaria Research and Training Center, University of Sciences, Techniques and Technologies, Bamako, Mali.
Amatigue ZeguimeMalaria Research and Training Center, University of Sciences, Techniques and Technologies, Bamako, Mali.
Amagana DoloMalaria Research and Training Center, University of Sciences, Techniques and Technologies, Bamako, Mali.
Kirsten E LykeMalaria Research Program, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Christopher V PloweMalaria Research Program, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Yonas AbebeSanaria, Inc, Rockville, Maryland, USA.
Gail E PotterThe Emmes Company, LLC, Rockville, MD, United States.
Jessie K KennedyThe Emmes Company, LLC, Rockville, MD, United States.
Shirley M GalbiatiThe Emmes Company, LLC, Rockville, MD, United States.
Effie NomicosParasitic and International Programs Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, U. S. National Institutes of Health, Bethesda, MD, United States.
Gregory A DeyeParasitic and International Programs Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, U. S. National Institutes of Health, Bethesda, MD, United States.
Thomas L RichieSanaria, Inc, Rockville, Maryland, USA.
Eric R JamesSanaria, Inc, Rockville, Maryland, USA.
Natasha KcSanaria, Inc, Rockville, Maryland, USA.
B Kim Lee SimSanaria, Inc, Rockville, Maryland, USA.
Stephen L HoffmanSanaria, Inc, Rockville, Maryland, USA.
Ogobara K DoumboMalaria Research and Training Center, University of Sciences, Techniques and Technologies, Bamako, Mali.
Mahamadou A TheraMalaria Research and Training Center, University of Sciences, Techniques and Technologies, Bamako, Mali.
Matthew B LaurensMalaria Research Program, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.
DMID 15-0052 PfSPZ-CVac Study Team
Université des Sciences, des Techniques et des Technologies de Bamako · MLSanaria · USEmmes (United States) · USUniversity of Maryland, Baltimore · USNational Institutes of Health · US

Funding

Universal Attenuated Sporozoite Vaccine and Challenge SystemR44AI058375 · NIAID · SANARIA, INC. · PI HOFFMAN, STEPHEN LEV · 2006 to 2018
$9.9M
NIAID NIH HHS HHSN272201300022CNIAID NIH HHS HHSN272201300022INIAID NIH HHS R44 AI058375
6 · The paper itself

Abstract

Background: Methods: Healthy 18-45 year olds were enrolled in a double-blind, placebo-controlled trial in Bougoula-Hameau, Mali, randomized 1:1 to 2.048 × 10 Findings: 62 participants were enrolled in April/May 2017. Proportions of participants experiencing at least one solicited systemic AE were similar between treatment arms: 6/31 (19.4%, 95%CI 9.2-36.3) of PfSPZ-CVac recipients versus 7/31 (22.6%, 95%CI 29.2-62.2) of controls ( Interpretation: PfSPZ-CVac (CQ) was well-tolerated. The tested dosing regimen failed to significantly protect against Pf infection in this very high transmission setting. Funding: U.S. National Institutes of Health, Sanaria. Registration number: ClinicalTrials.gov identifier (NCT number): NCT02996695.

Indexed as

ALT, alanine aminotransferaseCHMI, Controlled Human Malaria InfectionCQ, chloroquineCSP, circumsporozoite proteinDOT, directly observed therapyDVI, direct venous inoculationELISA, enzyme linked immunosorbent assayHR, hazard ratioMalaria vaccinePCR, polymerase chain reactionPf, Plasmodium falciparumPfSPZ-CVacPfSPZ-CVac, Plasmodium falciparum Sporozoite Chemoprophylaxis VaccinePfSPZ VaccinePlasmodium falciparumSMC, safety monitoring committeeSporozoiteSPZ, sporozoiteTBS, thick blood smearVE, vaccine efficacy

Identifiers

PMID35928033
PMCPMC9343417
OpenAlexW4288757735

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.