Evidence map›Paper›PMID 30540808›Full record

Trial reportPloS one2018

First field efficacy trial of the ChAd63 MVA ME-TRAP vectored malaria vaccine candidate in 5-17 months old infants and children.

Alfred B Tiono, Issa Nébié, Nicholas Anagnostou, Aboubacar S Coulibaly, Georgina Bowyer, Erika Lam, Edith C Bougouma, Alphonse Ouedraogo, Jean Baptist B Yaro, Aïssata Barry and 14 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01635647 (A Phase 1/2b Double Blind Randomised Controlled Trial of the Efficacy, Safety and Immunogenicity of Heterologous Prime-boost Immunisation With the Candidate Malaria Vaccines ChAd63 ME-TRAP and MVA ME-TRAP in 5-17 Month Old Burkinabe Infants and Children), which is not on this map. Cited by 40 papers.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed
12.6field-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.

NCT01635647 phase1 / phase2completednot on this map

A Phase 1/2b Double Blind Randomised Controlled Trial of the Efficacy, Safety and Immunogenicity of Heterologous Prime-boost Immunisation With the Candidate Malaria Vaccines ChAd63 ME-TRAP and MVA ME-TRAP in 5-17 Month Old Burkinabe Infants and Children

TypeinterventionalSponsorUniversity of OxfordRan2012 to 2014Enrolled730ConditionsMalariaArmsChAd63 ME-TRAP and MVA ME-TRAP, Rabies vaccine
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 92 citations in OpenAlex.

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  14. Malaria Vaccines: Progress to Date.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023
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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

24 authors at 4 institutions in 4 countries.

Alfred B TionoCentre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso.ORCID 0000-0002-5104-3946
Issa NébiéCentre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso.
Nicholas AnagnostouThe Jenner Institute, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.
Aboubacar S CoulibalyCentre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso.
Georgina BowyerThe Jenner Institute, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.
Erika LamThe Jenner Institute, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.
Edith C BougoumaCentre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso.
Alphonse OuedraogoCentre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso.
Jean Baptist B YaroCentre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso.
Aïssata BarryCentre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso.
Rachel RobertsThe Jenner Institute, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.
Tommy RamplingThe Jenner Institute, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.
Carly BlissThe Jenner Institute, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.
Susanne HodgsonThe Jenner Institute, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.
Alison LawrieThe Jenner Institute, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.
Amidou OuedraogoCentre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso.
Egeruan Babatunde ImoukhuedeThe Jenner Institute, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.
Katie J EwerThe Jenner Institute, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.ORCID 0000-0001-9827-9836
Nicola K ViebigEuropean Vaccine Initiative, Universitäts Klinikum Heidelberg, Heidelberg, Germany.
Amidou DiarraCentre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso.
Odile LeroyEuropean Vaccine Initiative, Universitäts Klinikum Heidelberg, Heidelberg, Germany.
Philip BejonKenya Medical Research Institute-Wellcome Trust Research Programme, Kilifi, Kenya.
Adrian V S HillThe Jenner Institute, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.
Sodiomon B SirimaCentre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso.
University of Oxford · GBCentre National de Recherche et de Formation sur le Paludisme · BFHeidelberg University · DEKenya Medical Research Institute · KE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHeterologous prime boost immunization with chimpanzee adenovirus 63 (ChAd63) and Modified Vaccinia Virus Ankara (MVA) vectored vaccines is a strategy previously shown to provide substantial protective efficacy against P. falciparum infection in United Kingdom adult Phase IIa sporozoite challenge studies (approximately 20-25% sterile protection with similar numbers showing clear delay in time to patency), and greater point efficacy in a trial in Kenyan adults. METHODOLOGY: We conducted the first Phase IIb clinical trial assessing the safety, immunogenicity and efficacy of ChAd63 MVA ME-TRAP in 700 healthy malaria exposed children aged 5-17 months in a highly endemic malaria transmission area of Burkina Faso.

resultsChAd63 MVA ME-TRAP was shown to be safe and immunogenic but induced only moderate T cell responses (median 326 SFU/106 PBMC (95% CI 290-387)) many fold lower than in previous trials. No significant efficacy was observed against clinical malaria during the follow up period, with efficacy against the primary endpoint estimate by proportional analysis being 13.8% (95%CI -42.4 to 47.9) at sixth month post MVA ME-TRAP and 3.1% (95%CI -15.0 to 18.3; p = 0.72) by Cox regression.

conclusionsThis study has confirmed ChAd63 MVA ME-TRAP is a safe and immunogenic vaccine regimen in children and infants with prior exposure to malaria. But no significant protective efficacy was observed in this very highly malaria-endemic setting.

trial registrationClinicalTrials.gov NCT01635647. Pactr.org PACTR201208000404131.

Indexed as

Adenoviruses, SimianDouble-Blind MethodEnzyme-Linked Immunosorbent AssayFemaleHumansInfantKaplan-Meier EstimateKenyaLeukocytes, MononuclearMalariaMalaria VaccinesMalePlasmodium falciparumT-LymphocytesVaccinia virusMalaria Vaccines

Identifiers

PMID30540808
PMCPMC6291132
OpenAlexW2903991686

What OpenQuestion holds

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LicenceCC BY
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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.