Evidence map›Paper›PMID 31621832›Full record

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

Chemoprophylaxis Vaccination: Phase I Study to Explore Stage-specific Immunity to Plasmodium falciparum in US Adults.

Sara A Healy, Sean C Murphy, Jen C C Hume, Lisa Shelton, Steve Kuntz, Wesley C Van Voorhis, Zoe Moodie, Barbara Metch, Ruobing Wang, Tiffany Silver-Brace and 14 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IRandomized 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 trial NCT01500980 (Infection-Treatment-Vaccination for Plasmodium Falciparum), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.3field-weighted citation impact, top 18% 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.

NCT01500980 phase1completednot on this map

Infection-Treatment-Vaccination for Plasmodium Falciparum

TypeinterventionalSponsorSeattle Children's HospitalRan2011 to 2012Enrolled36ConditionsMalariaArmsP. falciparum infection, Chloroquine, Primaquine
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Open forum infectious diseases · 2023
    Article
  5. Review
  6. Article
  7. Article
  8. 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

24 authors at 6 institutions in 1 country.

Sara A HealyCenter for Infectious Disease Research, Seattle, Washington, USA.
Sean C MurphyCenter for Infectious Disease Research, Seattle, Washington, USA.
Jen C C HumeCenter for Infectious Disease Research, Seattle, Washington, USA.
Lisa SheltonCenter for Infectious Disease Research, Seattle, Washington, USA.
Steve KuntzDepartment of Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, Washington, USA.
Wesley C Van VoorhisCenter for Emerging and Re-emerging Infectious Diseases, University of Washington, Seattle, Washington, USA.
Zoe MoodieVaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Barbara MetchVaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Ruobing WangCenter for Infectious Disease Research, Seattle, Washington, USA.
Tiffany Silver-BraceCenter for Infectious Disease Research, Seattle, Washington, USA.
Matthew FishbaugherCenter for Infectious Disease Research, Seattle, Washington, USA.
Mark KennedyCenter for Infectious Disease Research, Seattle, Washington, USA.
Olivia C FinneyCenter for Infectious Disease Research, Seattle, Washington, USA.
Richa ChaturvediCenter for Infectious Disease Research, Seattle, Washington, USA.
Sean R MarcsisinMilitary Malaria Research Program, Division of Experimental Therapeutics, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.
Charlotte V HobbsLaboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Margaret Warner-LubinCenter for Infectious Disease Research, Seattle, Washington, USA.
Angela K TalleyCenter for Infectious Disease Research, Seattle, Washington, USA.
Sharon Wong-MaddenCenter for Infectious Disease Research, Seattle, Washington, USA.
Ken StuartCenter for Infectious Disease Research, Seattle, Washington, USA.
Anna WaldDepartment of Laboratory Medicine and Microbiology, University of Washington, Seattle, Washington, USA.
Stefan H KappeCenter for Infectious Disease Research, Seattle, Washington, USA.
James G KublinCenter for Infectious Disease Research, Seattle, Washington, USA.
Patrick E DuffyCenter for Infectious Disease Research, Seattle, Washington, USA.
Infectious Disease Research Institute · USCenter for Infectious Disease Research · USUniversity of Washington · USFred Hutch Cancer Center · USNational Institute of Allergy and Infectious Diseases · USWalter Reed Army Institute of Research · US

Funding

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
Intramural NIH HHS ZIA AI001170
6 · The paper itself

Abstract

backgroundChemoprophylaxis vaccination with sporozoites (CVac) with chloroquine induces protection against a homologous Plasmodium falciparum sporozoite (PfSPZ) challenge, but whether blood-stage parasite exposure is required for protection remains unclear. Chloroquine suppresses and clears blood-stage parasitemia, while other antimalarial drugs, such as primaquine, act against liver-stage parasites. Here, we evaluated CVac regimens using primaquine and/or chloroquine as the partner drug to discern whether blood-stage parasite exposure impacts protection against homologous controlled human malaria infection.

methodsIn a Phase I, randomized, partial double-blind, placebo-controlled study of 36 malaria-naive adults, all CVac subjects received chloroquine prophylaxis and bites from 12-15 P. falciparum-infected mosquitoes (CVac-chloroquine arm) at 3 monthly iterations, and some received postexposure primaquine (CVac-primaquine/chloroquine arm). Drug control subjects received primaquine, chloroquine, and uninfected mosquito bites. After a chloroquine washout, subjects, including treatment-naive infectivity controls, underwent homologous, PfSPZ controlled human malaria infection and were monitored for parasitemia for 21 days.

resultsNo serious adverse events occurred. During CVac, all but 1 subject in the study remained blood-smear negative, while only 1 subject (primaquine/chloroquine arm) remained polymerase chain reaction-negative. Upon challenge, compared to infectivity controls, 3/3 chloroquine arm subjects displayed delayed patent parasitemia (P = .01) but not sterile protection, while 3/11 primaquine/chloroquine subjects remained blood-smear negative.

conclusionsCVac-primaquine/chloroquine is safe and induces sterile immunity to P. falciparum in some recipients, but a single 45 mg dose of primaquine postexposure does not completely prevent blood-stage parasitemia. Unlike previous studies, CVac-chloroquine did not produce sterile immunity. CLINICAL TRIALS REGISTRATION: NCT01500980.

Indexed as

AntimalarialsMalaria, FalciparumAdultAnimalsChemopreventionHumansPlasmodium falciparumSporozoitesVaccinationAntimalarialschemoprophylaxis vaccination with sporozoiteschloroquinemalariaPlasmodium falciparumprimaquine

Identifiers

PMID31621832
PMCPMC7486848
OpenAlexW2980725444

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.