Evidence map›Paper›PMID 29438525›Full record

Trial reportThe Journal of infectious diseases2018

Immunization of Malaria-Preexposed Volunteers With PfSPZ Vaccine Elicits Long-Lived IgM Invasion-Inhibitory and Complement-Fixing Antibodies.

Isabelle Zenklusen, Said Jongo, Salim Abdulla, Kamaka Ramadhani, B Kim Lee Sim, Hayley Cardamone, Erika L Flannery, Thao Nguyen, Matthew Fishbaugher, Ryan W J Steel and 7 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02132299 (Phase 1, Dose Escalation, Randomized Controlled Trial to Evaluate the Safety, Immunogenicity and Efficacy of Intravenously Administered Attenuated Plasmodium Falciparum Sporozoite Vaccine), which is not on this map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
7.6field-weighted citation impact, top 3% 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.

NCT02132299 phase1completednot on this map

Phase 1, Dose Escalation, Randomized Controlled Trial to Evaluate the Safety, Immunogenicity and Efficacy of Intravenously Administered Attenuated Plasmodium Falciparum Sporozoite Vaccine (PfSPZ Vaccine) in Tanzanian Adults

TypeinterventionalSponsorSanaria Inc.Ran2014 to 2015Enrolled67ConditionsMalaria, Plasmodium Falciparum MalariaArmsPfSPZ Vaccine, Normal Saline (Placebo), PfSPZ Challenge
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 1 synthesis or guideline pooled it, 49 citations in OpenAlex.

  1. Malaria and the Microbiome: A Systematic Review.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018
    Pooled it
  2. Review
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  15. Review
  16. Review
  17. Immune Responses in Malaria and Vaccine Strategies.Advances in experimental medicine and biology · 2021
    Article
  18. Review
  19. Article
  20. Immunization with full-lengthNPJ vaccines · 2020
    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

17 authors at 5 institutions in 3 countries.

Isabelle ZenklusenClinical Immunology Unit, Swiss Tropical and Public Health Institute, Basel, Switzerland.
Said JongoIfakara Health Institute, Clinical Trial Unit, Bagamoyo, Tanzania.
Salim AbdullaIfakara Health Institute, Clinical Trial Unit, Bagamoyo, Tanzania.
Kamaka RamadhaniIfakara Health Institute, Clinical Trial Unit, Bagamoyo, Tanzania.
B Kim Lee SimSanaria Inc., Rockville, Maryland.
Hayley CardamoneCenter for Infectious Disease Research, Seattle, Washington.
Erika L FlanneryCenter for Infectious Disease Research, Seattle, Washington.
Thao NguyenCenter for Infectious Disease Research, Seattle, Washington.
Matthew FishbaugherCenter for Infectious Disease Research, Seattle, Washington.
Ryan W J SteelCenter for Infectious Disease Research, Seattle, Washington.
Will BetzCenter for Infectious Disease Research, Seattle, Washington.
Nelly CarmagoCenter for Infectious Disease Research, Seattle, Washington.
Sebastian MikolajczakCenter for Infectious Disease Research, Seattle, Washington.
Stefan H I KappeCenter for Infectious Disease Research, Seattle, Washington.
Stephen L HoffmanSanaria Inc., Rockville, Maryland.
Brandon K SackCenter for Infectious Disease Research, Seattle, Washington.
Claudia DaubenbergerClinical Immunology Unit, Swiss Tropical and Public Health Institute, Basel, Switzerland.
Center for Infectious Disease Research · USInfectious Disease Research Institute · USIfakara Health Institute · TZSanaria · 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
Mechanisms of antibody protection in pre-erythrocytic and blood stage malariaF32AI114113 · NIAID · SEATTLE BIOMEDICAL RESEARCH INSTITUTE · PI WILDER, BRANDON KEITH · 2014 to 2016
$164k
NIAID NIH HHS F32 AI114113NIAID NIH HHS R44 AI055229
6 · The paper itself

Abstract

Background: The assessment of antibody responses after immunization with radiation-attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (Sanaria PfSPZ Vaccine) has focused on IgG isotype antibodies. Here, we aimed to investigate if P. falciparum sporozoite binding and invasion-inhibitory IgM antibodies are induced following immunization of malaria-preexposed volunteers with PfSPZ Vaccine. Methods: Using serum from volunteers immunized with PfSPZ, we measured vaccine-induced IgG and IgM antibodies to P. falciparum circumsporozoite protein (PfCSP) via ELISA. Function of this serum as well as IgM antibody fractions was measured via in vitro in an inhibition of sporozoite invasion assay. These IgM antibody fractions were also measured for binding to sporozoites by immunofluorescence assay and complement fixation on whole sporozoites. Results: We found that in addition to anti-PfCSP IgG, malaria-preexposed volunteers developed anti-PfCSP IgM antibodies after immunization with PfSPZ Vaccine and that these IgM antibodies inhibited P. falciparum sporozoite invasion of hepatocytes in vitro. These IgM plasma fractions also fixed complement to whole P. falciparum sporozoites. Conclusions: This is the first finding that PfCSP and P. falciparum sporozoite-binding IgM antibodies are induced following immunization of PfSPZ Vaccine in malaria-preexposed individuals and that IgM antibodies can inhibit P. falciparum sporozoite invasion into hepatocytes in vitro and fix complement on sporozoites. These findings indicate that the immunological assessment of PfSPZ Vaccine-induced antibody responses could be more sensitive if they include parasite-specific IgM in addition to IgG antibodies. Clinical Trials Registration: NCT02132299.

Indexed as

AdultAntibodies, ProtozoanAntibody FormationDouble-Blind MethodHumansImmunizationImmunoglobulin MMalariaMalaria, FalciparumMalaria VaccinesMalePlasmodium falciparumSporozoitesVaccinationVaccines, AttenuatedVolunteersAntibodies, ProtozoanImmunoglobulin MMalaria VaccinesVaccines, Attenuated

Identifiers

PMID29438525
PMCPMC5913598
OpenAlexW2790641538

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.