Evidence map›Paper›PMID 34518679›Full record

Trial reportNature medicine2021

Safety, immunogenicity and efficacy of PfSPZ Vaccine against malaria in infants in western Kenya: a double-blind, randomized, placebo-controlled phase 2 trial.

Martina Oneko, Laura C Steinhardt, Reuben Yego, Ryan E Wiegand, Phillip A Swanson, Natasha Kc, Dorcas Akach, Tony Sang, Julie R Gutman, Elizabeth L Nzuu and 20 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Nature medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02687373 (Safety, Tolerability and Efficacy of PfSPZ Vaccine Administered by Direct Venous Inoculation), which is not on this map. Cited by 63 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 2 pooled it
15.9field-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.

NCT02687373 phase1 / phase2completednot on this map

Safety, Tolerability and Efficacy of PfSPZ Vaccine Administered by Direct Venous Inoculation (DVI) to Healthy Children and Infants 5 Months Through 9 Years of Age Living in an Area of High Malaria Transmission in Western Kenya: Age De-escalation and Dose Escalation and a Double Blind, Randomized Placebo-Controlled Trial for Safety and Efficacy

TypeinterventionalSponsorSanaria Inc.Ran2016 to 2018Enrolled337ConditionsMalariaArmsPfSPZ Vaccine, Normal Saline
3 · Its place in the literature

Who cites it

63 citing papers in PubMed, 2 syntheses or guidelines pooled it, 99 citations in OpenAlex.

  1. Pooled it
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  7. Genotypic analysis of RTS,S/AS01The Lancet. Infectious diseases · 2024
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  16. Vaccine Distribution Logistics.Methods in molecular biology (Clifton, N.J.) · 2026
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3 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

30 authors at 8 institutions in 4 countries.

Martina Oneko *Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya. tinaoneko@gmail.com.ORCID http://orcid.org/0000-0003-0021-3324
Laura C Steinhardt *Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.ORCID http://orcid.org/0000-0003-0540-9940
Reuben YegoKenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.
Ryan E WiegandMalaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.ORCID http://orcid.org/0000-0002-9486-1850
Phillip A SwansonVaccine Research Center, National Institutes of Health, Bethesda, MD, USA.
Natasha KcSanaria, Rockville, MD, USA.
Dorcas AkachKenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.
Tony SangKenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.
Julie R GutmanMalaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.ORCID http://orcid.org/0000-0001-6769-7322
Elizabeth L NzuuKenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.
Allan DunganiKenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.
B Kim Lee Sim
Paul Ndaya OlooKenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.ORCID http://orcid.org/0000-0002-9771-5525
Kephas OtienoKenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.
Dennis K BiiKenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.
Peter F BillingsleySanaria, Rockville, MD, USA.ORCID http://orcid.org/0000-0003-1142-4813
Eric R JamesSanaria, Rockville, MD, USA.
Simon KariukiKenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.
Aaron M SamuelsMalaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.ORCID http://orcid.org/0000-0002-8355-8186
Said JongoBagamoyo Research and Training Centre, Ifakara Health Institute, Bagamoyo, Tanzania.
Winnie CheboreKenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.
Salim AbdullaBagamoyo Research and Training Centre, Ifakara Health Institute, Bagamoyo, Tanzania.
Claudia DaubenbergerSwiss Tropical and Public Health Institute, Basel, Switzerland.
Maxmillian MpinaBagamoyo Research and Training Centre, Ifakara Health Institute, Bagamoyo, Tanzania.
David StyersThe Emmes Corporation, Rockville, MD, USA.
Gail E PotterThe Emmes Corporation, Rockville, MD, USA.
Ginnie AbarbanellWashington University School of Medicine and St Louis Children's Hospital, St Louis, MO, USA.
Thomas L RichieSanaria, Rockville, MD, USA.ORCID http://orcid.org/0000-0002-2946-5456
Stephen L HoffmanSanaria, Rockville, MD, USA.ORCID http://orcid.org/0000-0002-0700-9505
Robert A SederVaccine Research Center, National Institutes of Health, Bethesda, MD, USA. rseder@mail.nih.gov.ORCID http://orcid.org/0000-0003-3133-0849
Kenya Medical Research Institute · KESanaria · USCenters for Disease Control and Prevention · USIfakara Health Institute · TZEmmes (United States) · USNational Institutes of Health · USSt. Louis Children's Hospital · USSwiss Tropical and Public Health Institute · CH

Funding

Plasmodium Falciparum Whole Sporozoite Malaria VaccineR44AI055229 · NIAID · SANARIA, INC. · PI HOFFMAN, STEPHEN LEV · 2005 to 2015
$10.0M
Universal Attenuated Sporozoite Vaccine and Challenge SystemR44AI058375 · NIAID · SANARIA, INC. · PI HOFFMAN, STEPHEN LEV · 2006 to 2018
$9.9M
NIAID NIH HHS R44 AI055229NIAID NIH HHS R44 AI058375
6 · The paper itself

Abstract

The radiation-attenuated Plasmodium falciparum sporozoite (PfSPZ) vaccine provides protection against P. falciparum infection in malaria-naïve adults. Preclinical studies show that T cell-mediated immunity is required for protection and is readily induced in humans after vaccination. However, previous malaria exposure can limit immune responses and vaccine efficacy (VE) in adults. We hypothesized that infants with less previous exposure to malaria would have improved immunity and protection. We conducted a multi-arm, randomized, double-blind, placebo-controlled trial in 336 infants aged 5-12 months to determine the safety, tolerability, immunogenicity and efficacy of the PfSPZ Vaccine in infants in a high-transmission malaria setting in western Kenya ( NCT02687373 ). Groups of 84 infants each received 4.5 × 10

Indexed as

AdultAntibody FormationB-LymphocytesDouble-Blind MethodHumansInfantKenyaMalaria, FalciparumMalaria VaccinesPlasmodium falciparumSporozoitesT-LymphocytesVaccinationVaccines, AttenuatedMalaria VaccinesVaccines, Attenuated

Identifiers

PMID34518679
OpenAlexW3201018583

What OpenQuestion holds

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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.