Evidence map›Paper›PMID 31782768›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2020

Increase of Dose Associated With Decrease in Protection Against Controlled Human Malaria Infection by PfSPZ Vaccine in Tanzanian Adults.

Said A Jongo, L W Preston Church, Ali T Mtoro, Tobias Schindler, Sumana Chakravarty, Adam J Ruben, Phillip A Swanson, Kamaka R Kassim, Maximillian Mpina, Anneth-Mwasi Tumbo and 23 more

2 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020. 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 45 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 1 pooled it
10.4field-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.

NCT02613520 phase1completednot on this map

Clinical Trial to Evaluate the Safety and Immunogenicity in Age De-Escalation of Direct Venous Inoculation of a Plasmodium Falciparum Sporozoite Vaccine in Tanzanian Adults, Children, and Infants

TypeinterventionalSponsorSanaria Inc.Ran2015 to 2017Enrolled105ConditionsMalariaArmsPfSPZ Vaccine, Normal Saline, PfSPZ Challenge (for CHMI)
NCT03510481 phase1completednot on this map

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)
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 1 synthesis or guideline pooled it, 71 citations in OpenAlex.

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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

33 authors at 7 institutions in 3 countries.

Said A JongoIfakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
L W Preston ChurchSanaria Inc., Rockville, Maryland, USA.
Ali T MtoroIfakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
Tobias SchindlerSwiss Tropical and Public Health Institute, Basel, Switzerland.
Sumana ChakravartySanaria Inc., Rockville, Maryland, USA.
Adam J RubenSanaria Inc., Rockville, Maryland, USA.
Phillip A SwansonVaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Kamaka R KassimIfakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
Maximillian MpinaSwiss Tropical and Public Health Institute, Basel, Switzerland.
Anneth-Mwasi TumboSwiss Tropical and Public Health Institute, Basel, Switzerland.
Florence A MilandoIfakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
Munira QassimIfakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
Omar A JumaIfakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
Bakari M BakariIfakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
Beatus SimonIfakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
Eric R JamesSanaria Inc., Rockville, Maryland, USA.
Yonas AbebeSanaria Inc., Rockville, Maryland, USA.
Natasha KcSanaria Inc., Rockville, Maryland, USA.
Elizabeth SaverinoSanaria Inc., Rockville, Maryland, USA.
Martina FinkSwiss Tropical and Public Health Institute, Basel, Switzerland.
Glenda CosiSwiss Tropical and Public Health Institute, Basel, Switzerland.
Linda GondweSwiss Tropical and Public Health Institute, Basel, Switzerland.
Fabian StuderSwiss Tropical and Public Health Institute, Basel, Switzerland.
David StyersThe Emmes Corporation, Rockville, Maryland, USA.
Robert A SederVaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Tobias SchindlerSwiss Tropical and Public Health Institute, Basel, Switzerland.
Peter F BillingsleySanaria Inc., Rockville, Maryland, USA.
Claudia DaubenbergerSwiss Tropical and Public Health Institute, Basel, Switzerland.
B Kim Lee SimSanaria Inc., Rockville, Maryland, USA.
Marcel TannerSwiss Tropical and Public Health Institute, Basel, Switzerland.
Thomas L RichieSanaria Inc., Rockville, Maryland, USA.
Salim AbdullaIfakara Health Institute, Bagamoyo Research and Training Centre, Bagamoyo, Tanzania.
Stephen L HoffmanSanaria Inc., Rockville, Maryland, USA.
Sanaria · USIfakara Health Institute · TZSwiss Tropical and Public Health Institute · CHUniversity of Basel · CHNational Institute of Allergy and Infectious Diseases · USEmmes (United States) · USProtein Potential (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA vaccine would be an ideal tool for reducing malaria's impact. PfSPZ Vaccine (radiation attenuated, aseptic, purified, cryopreserved Plasmodium falciparum [Pf] sporozoites [SPZ]) has been well tolerated and safe in >1526 malaria-naive and experienced 6-month to 65-year-olds in the United States, Europe, and Africa. When vaccine efficacy (VE) of 5 doses of 2.7 × 105 PfSPZ of PfSPZ Vaccine was assessed in adults against controlled human malaria infection (CHMI) in the United States and Tanzania and intense field transmission of heterogeneous Pf in Mali, Tanzanians had the lowest VE (20%).

methodsTo increase VE in Tanzania, we increased PfSPZ/dose (9 × 105 or 1.8 × 106) and decreased numbers of doses to 3 at 8-week intervals in a double blind, placebo-controlled trial.

resultsAll 22 CHMIs in controls resulted in parasitemia by quantitative polymerase chain reaction. For the 9 × 105 PfSPZ group, VE was 100% (5/5) at 3 or 11 weeks (P < .000l, Barnard test, 2-tailed). For 1.8 × 106 PfSPZ, VE was 33% (2/6) at 7.5 weeks (P = .028). VE of dosage groups (100% vs 33%) was significantly different (P = .022). Volunteers underwent repeat CHMI at 37-40 weeks after last dose. 6/6 and 5/6 volunteers developed parasitemia, but time to first parasitemia was significantly longer than controls in the 9 × 105 PfSPZ group (10.89 vs 7.80 days) (P = .039), indicating a significant reduction in parasites in the liver. Antibody and T-cell responses were higher in the 1.8 × 106 PfSPZ group.

conclusionsIn Tanzania, increasing the dose from 2.7 × 105 to 9 × 105 PfSPZ increased VE from 20% to 100%, but increasing to 1.8 × 106 PfSPZ significantly reduced VE. CLINICAL TRIALS REGISTRATION: NCT02613520.

Indexed as

MalariaMalaria, FalciparumMalaria VaccinesAdultAnimalsEuropeHumansMaliPlasmodium falciparumSporozoitesTanzaniaMalaria Vaccinescontrolled human malaria infectionmalariaPfSPZPlasmodium falciparumvaccine efficacy

Identifiers

PMID31782768
PMCPMC7947995
OpenAlexW2991047882

What OpenQuestion holds

Textmetadata
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.