Evidence map›Paper›PMID 19874925›Full record

Trial reportVaccine2009

A randomized and controlled Phase 1 study of the safety and immunogenicity of the AMA1-C1/Alhydrogel + CPG 7909 vaccine for Plasmodium falciparum malaria in semi-immune Malian adults.

Issaka Sagara, Ruth D Ellis, Alassane Dicko, Mohamed B Niambele, Beh Kamate, Ousmane Guindo, Mahamadou S Sissoko, Michael P Fay, Merepen A Guindo, Ousmane Kante and 11 more

Abstract readClinical Trial, Phase IRandomized 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 43 papers.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed
10.8field-weighted citation impact, top 2% 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

43 citing papers in PubMed, 82 citations in OpenAlex.

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  17. Immune Mechanisms Involved inFrontiers in immunology · 2018
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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

21 authors at 4 institutions in 2 countries.

Issaka SagaraMalaria Research and Training Center, Faculty of Medicine Pharmacy and Dentistry, BP 1805, Bamako, University of Bamako, Mali. isagara@icermali.org
Ruth D Ellis
Alassane Dicko
Mohamed B Niambele
Beh Kamate
Ousmane Guindo
Mahamadou S Sissoko
Michael P Fay
Merepen A Guindo
Ousmane Kante
Renion Saye
Kazutoyo Miura
Carole Long
Gregory E D Mullen
Mark Pierce
Laura B Martin
Kelly Rausch
Amagana Dolo
Dapa A Diallo
Louis H Miller
Ogobara K Doumbo
University of Bamako · MLNational Institute of Allergy and Infectious Diseases · USNational Institutes of Health · USVector Oncology (United States) · US

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
Host Immune Responses to Antigens of Malaria ParasitesZIAAI001020 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI LONG, CAROLE · 2009 to 2025
$13.6M
Malaria Vaccine: AMA1-C1ZIAAI001001 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI DUFFY, PATRICK · 2009 to 2012
$5.1M
Mali International Center for Excellence in Research: Malaria Clinical ResearchZ01AI001056 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI ELLIS, RUTH · 2008 to 2008
$2.0M
Intramural NIH HHS Z01 AI001056Intramural NIH HHS ZIA AI001056
6 · The paper itself

Abstract

A double blind, randomized and controlled Phase 1 clinical trial was conducted to assess the safety and immunogenicity in malaria-exposed adults of the Plasmodium falciparum blood stage vaccine candidate Apical Membrane Antigen 1-Combination 1 (AMA1-C1)/Alhydrogel with and without the novel adjuvant CPG 7909. Participants were healthy adults 18-45 years old living in the village of Donéguébougou, Mali. A total of 24 participants received 2 doses one month apart of either 80 microg AMA1-C1/Alhydrogel or 80 microg AMA1-C1/Alhydrogel + 564 microg CPG 7909. The study started in October 2007 and completed follow up in May 2008. Both vaccines were well tolerated, with only mild local adverse events and no systemic adverse events judged related to vaccination. The difference in antibody responses were over 2-fold higher in the group receiving CPG 7909 for all time points after second vaccination and the differences are statistically significant (all p<0.05). This is the first use of the novel adjuvant CPG 7909 in a malaria-exposed population.

Indexed as

Adjuvants, ImmunologicAdultAluminum HydroxideAntibodies, ProtozoanAntigens, ProtozoanDouble-Blind MethodFemaleHumansMalaria, FalciparumMalaria VaccinesMaleMaliMembrane ProteinsOligodeoxyribonucleotidesPlasmodium falciparumProtozoan ProteinsAdjuvants, ImmunologicAluminum HydroxideAntibodies, ProtozoanAntigens, Protozoanapical membrane antigen I, PlasmodiumMalaria VaccinesMembrane ProteinsOligodeoxyribonucleotidesProMuneProtozoan Proteins

Identifiers

PMID19874925
PMCPMC2808270
OpenAlexW2065385462

What OpenQuestion holds

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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.