Evidence map›Paper›PMID 32444192›Full record

ArticleVaccine2020

Feasibility of direct venous inoculation of the radiation-attenuated Plasmodium falciparum whole sporozoite vaccine in children and infants in Siaya, western Kenya.

M Oneko, Y R Cherop, T Sang, J R Gutman, R Wiegand, E M Nyang'au, A D Odila, D Akach, M J Hamel, A M Samuels and 11 more

Registry-linked trialOpen access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Vaccine, 2020. 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 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.3field-weighted citation impact, top 19% 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

7 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
  7. 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

21 authors at 6 institutions in 2 countries.

M OnekoKenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya. Electronic address: moneko@kemricdc.org.
Y R CheropKenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.
T SangKenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.
J R GutmanMalaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.
R WiegandMalaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.
E M Nyang'auKenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.
A D OdilaKenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.
D AkachKenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.
M J HamelMalaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.
A M SamuelsMalaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.
S KariukiKenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.
Y AbebeSanaria Inc., Rockville, MD, USA.
E L NzuuKenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.
W WijayalathSanaria Inc., Rockville, MD, USA.
E R JamesSanaria Inc., Rockville, MD, USA.
B K L SimSanaria Inc., Rockville, MD, USA.
P F BillingsleySanaria Inc., Rockville, MD, USA.
T L RichieSanaria Inc., Rockville, MD, USA.
S L HoffmanSanaria Inc., Rockville, MD, USA.
R A SederNational Institutes of Health, Bethesda, MD, USA.
L C SteinhardtMalaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Kenya Medical Research Institute · KESanaria · USCenter for Global Health · USCenters for Disease Control and Prevention · USDivision of Parasitic Diseases and Malaria · USNational Institutes of Health · US

Funding

Development of Pre-Erythrocytic Malaria Vaccines and antibodiesZIAAI005107 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI SEDER, ROBERT A · 2010 to 2025
$20.7M
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
Intramural NIH HHS ZIA AI005107NIAID NIH HHS R44 AI055229NIAID NIH HHS R44 AI058375
6 · The paper itself

Abstract

PfSPZ Vaccine, composed of radiation-attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites, is administered by direct venous inoculation (DVI) for maximal efficacy against malaria. A critical issue for advancing vaccines that are administered intravenously is the ability to efficiently administer them across multiple age groups. As part of a pediatric safety, immunogenicity, and efficacy trial in western Kenya, we evaluated the feasibility and tolerability of DVI, including ease of venous access, injection time, and crying during the procedure across age groups. Part 1 was an age de-escalation, dose escalation trial in children aged 13 months-5 years and infants aged 5-12 months; part 2 was a vaccine efficacy trial including only infants, using the most skilled injectors from part 1. Injectors could use a vein viewer, if needed. A total of 1222 injections (target 0.5 mL) were initiated by DVI in 511 participants (36 were 5-9-year-olds, 65 were 13-59-month-olds, and 410 infants). The complete volume was injected in 1185/1222 (97.0%) vaccinations, 1083/1185 (91.4%) achieved with the first DVI. 474/511 (92.8%) participants received only complete injections, 27/511 (5.3%) received at least one partial injection (<0.5 mL), and in 10/511 (2.0%) venous access was not obtained. The rate of complete injections by single DVI for infants improved from 77.1% in part 1 to 92.8% in part 2. No crying occurred in 51/59 (86.4%) vaccinations in 5-9-year-olds, 25/86 (29.1%) vaccinations in 13-59-month-olds and 172/1067 (16.1%) vaccinations in infants. Mean administration time ranged from 2.6 to 4.6 minutes and was longer for younger age groups. These data show that vaccination by DVI was feasible and well tolerated in infants and children in this rural hospital in western Kenya, when performed by skilled injectors. We also report that shipping and storage in liquid nitrogen vapor phase was simple and efficient. (Clinicaltrials.gov NCT02687373).

Indexed as

Malaria, FalciparumMalaria VaccinesAdolescentAnimalsChildChild, PreschoolFeasibility StudiesHumansInfantKenyaPlasmodium falciparumSporozoitesVaccinationVaccines, AttenuatedMalaria VaccinesVaccines, AttenuatedAfricaDirect venous inoculationFeasibilityInfantsMalaria vaccinePlasmodium falciparum whole sporozoite Vaccine

Identifiers

PMID32444192
PMCPMC7297289
OpenAlexW3028200012

What OpenQuestion holds

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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.