Evidence map›Paper›PMID 19428923›Full record

Trial reportVaccine2009

A randomized controlled phase 2 trial of the blood stage AMA1-C1/Alhydrogel malaria vaccine in children in Mali.

Issaka Sagara, Alassane Dicko, Ruth D Ellis, Michael P Fay, Sory I Diawara, Mahamadoun H Assadou, Mahamadou S Sissoko, Mamady Kone, Abdoulbaki I Diallo, Renion Saye and 12 more

Open access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Vaccine, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 96 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
96citing papers in PubMed, 1 pooled it
20.9field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

96 citing papers in PubMed, 1 synthesis or guideline pooled it, 179 citations in OpenAlex.

  1. Pooled it
  2. Trial
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  6. A field trial to assess a blood-stage malaria vaccine.The New England journal of medicine · 2011
    Trial
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  15. Article
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  17. Malaria Vaccines: Progress to Date.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023
    Review
  18. Review
  19. Article
  20. Article

36 more citing papers are in PubMed but not listed here.

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

22 authors at 4 institutions in 4 countries.

Issaka SagaraMalaria Research and Training Center, Faculty of Medicine Pharmacy and Dentistry BP 1805 Bamako, University of Bamako, Mali, Malaysia. isagara@mrtcbko.org
Alassane Dicko
Ruth D Ellis
Michael P Fay
Sory I Diawara
Mahamadoun H Assadou
Mahamadou S Sissoko
Mamady Kone
Abdoulbaki I Diallo
Renion Saye
Merepen A Guindo
Ousmane Kante
Mohamed B Niambele
Kazutoyo Miura
Gregory E D Mullen
Mark Pierce
Laura B Martin
Amagana Dolo
Dapa A Diallo
Ogobara K Doumbo
Louis H Miller
Allan Saul
University of Bamako · MLNational Institute of Allergy and Infectious Diseases · USNational Institutes of Health · USLaboratoire d’Imagerie Biomédicale · FR

Funding

Mali International Center for Excellence in Research: Malaria Clinical ResearchZIAAI001056 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI DUFFY, PATRICK · 2009 to 2024
$43.1M
Malaria Parasite Receptors And Host Cell LigandsZIAAI000241 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI MILLER, LOUIS · 2009 to 2025
$15.3M
Malaria Vaccine: AMA1-C1ZIAAI001001 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI DUFFY, PATRICK · 2009 to 2012
$5.1M
Intramural NIH HHS Z99 AI999999
6 · The paper itself

Abstract

A double blind, randomized, controlled Phase 2 clinical trial was conducted to assess the safety, immunogenicity, and biologic impact of the vaccine candidate Apical Membrane Antigen 1-Combination 1 (AMA1-C1), adjuvanted with Alhydrogel. Participants were healthy children 2-3 years old living in or near the village of Bancoumana, Mali. A total of 300 children received either the study vaccine or the comparator. No impact of vaccination was seen on the primary endpoint, the frequency of parasitemia measured as episodes >3000/microL/day at risk. There was a negative impact of vaccination on the hemoglobin level during clinical malaria, and mean incidence of hemoglobin <8.5 g/dL, in the direction of lower hemoglobin in the children who received AMA1-C1, although these differences were not significant after correction for multiple tests. These differences were not seen in the second year of transmission.

Indexed as

Adjuvants, ImmunologicAluminum HydroxideAnemiaAnimalsAntibody FormationAntigens, ProtozoanChild, PreschoolDouble-Blind MethodFemaleHemoglobinsHumansMalaria, FalciparumMalaria VaccinesMaleMaliPlasmodium falciparumAdjuvants, ImmunologicAluminum HydroxideAntigens, ProtozoanHemoglobinsMalaria Vaccines

Identifiers

PMID19428923
PMCPMC2713037
OpenAlexW2052688453

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.