Evidence map›Paper›PMID 19356621›Full record

Trial reportVaccine2009

Cell-mediated immunity elicited by the blood stage malaria vaccine apical membrane antigen 1 in Malian adults: results of a Phase I randomized trial.

Kirsten E Lyke, Modibo Daou, Issa Diarra, Abdoulaye Kone, Bourema Kouriba, Mohamadou A Thera, Sheetij Dutta, David E Lanar, D Gray Heppner, Ogobara K Doumbo and 2 more

Open access · greenAbstract 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 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
3.6field-weighted citation impact, top 8% 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

12 citing papers in PubMed, 21 citations in OpenAlex.

  1. A field trial to assess a blood-stage malaria vaccine.The New England journal of medicine · 2011
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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

12 authors at 3 institutions in 2 countries.

Kirsten E LykeCenter for Vaccine Development, University of Maryland, Baltimore, MD, United States. KLyke@medicine.umaryland.edu
Modibo Daou
Issa Diarra
Abdoulaye Kone
Bourema Kouriba
Mohamadou A Thera
Sheetij Dutta
David E Lanar
D Gray Heppner
Ogobara K Doumbo
Christopher V Plowe
Marcelo B Sztein
University of Bamako · MLUniversity of Maryland, Baltimore · USWalter Reed Army Institute of Research · US

Funding

Safety, Immunogenicity and Efficacy of VaccineU19AI065683 · NIAID · UNIVERSITY OF MARYLAND BALTIMORE · PI PLOWE, CHRISTOPHER V. · 2005 to 2009
$4.7M
NIAID NIH HHS U19 AI065683
6 · The paper itself

Abstract

The development of a safe and effective malaria vaccine is impeded by the complexity of the Plasmodium life cycle. A vaccine that elicits both cell-mediated and humoral immune responses might be needed for protection against this multistage parasitic infection. Apical membrane antigen 1 (AMA-1) plays a key role in erythrocytic invasion but is also expressed in sporozoites and in late stage liver schizonts, where it may provide a target of protective cell-mediated immunity (CMI). A Phase 1 trial of a vaccine consisting of recombinant AMA-1 protein and the Adjuvant system AS02A was conducted in 60 Malian adults aged 18-55 years who were randomized to receive either half-dose (25 microg/0.25 ml) or full dose (50 microg/0.5 ml) FMP2.1/AS02A or a control rabies vaccine. Interleukin 5 (IL-5) and interferon-gamma (IFN-gamma) production as evaluated by ELISpot and lymphocyte proliferation were measured after in vitro AMA-1 stimulation of peripheral blood mononuclear cells (PBMCs) collected on Days 0 and 90. Post-FMP2.1/AS02A immunization mean stimulation indices were significantly elevated as were the number of IL-5 spot forming cells (SFC)/10(6) PBMC, but no difference was noted in INF-gamma production between the AMA-1/AS02A vaccinated group and the rabies group. These results provide evidence that complex immune responses can be induced by this vaccination strategy and add further impetus for the continuing clinical evaluation of this vaccine.

Indexed as

AdultAnimalsAntibodies, ProtozoanAntigens, ProtozoanCell ProliferationCells, CulturedDouble-Blind MethodHumansImmunity, CellularInterferon-gammaInterleukin-5Malaria, FalciparumMalaria VaccinesMembrane ProteinsMiddle AgedPlasmodium falciparumAntibodies, ProtozoanAntigens, Protozoanapical membrane antigen I, PlasmodiumInterferon-gammaInterleukin-5Malaria VaccinesMembrane ProteinsProtozoan Proteins

Identifiers

PMID19356621
PMCPMC2707027
OpenAlexW1973084607

What OpenQuestion holds

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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.