Evidence map›Paper›PMID 30629148›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2019

First-in-human, Randomized, Double-blind Clinical Trial of Differentially Adjuvanted PAMVAC, A Vaccine Candidate to Prevent Pregnancy-associated Malaria.

Benjamin Mordmüller, Mihály Sulyok, Diane Egger-Adam, Mafalda Resende, Willem A de Jongh, Mette H Jensen, Helle Holm Smedegaard, Sisse B Ditlev, Max Soegaard, Lars Poulsen and 17 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02647489 (Safety and Immunogenicity of the Placental Malaria Vaccine Candidate PAMVAC Adjuvanted With Alhydrogel, GLA-SE or GLA-LSQ in Healthy Malaria-Naïve Adults and Healthy, Lifelong Malaria-Exposed, Nulligravid Adult Women), which is not on this map. Cited by 89 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
89citing papers in PubMed, 2 pooled it
22.2field-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.

NCT02647489 phase1completednot on this map

Safety and Immunogenicity of the Placental Malaria Vaccine Candidate PAMVAC Adjuvanted With Alhydrogel, GLA-SE or GLA-LSQ in Healthy Malaria-Naïve Adults and Healthy, Lifelong Malaria-Exposed, Nulligravid Adult Women

TypeinterventionalSponsorUniversity Hospital TuebingenRan2016 to 2017Enrolled66ConditionsMalaria, AntepartumArmsPAMVAC, Alhydrogel, GLA-SE, GLA-LSQ, Placebo
3 · Its place in the literature

Who cites it

89 citing papers in PubMed, 2 syntheses or guidelines pooled it, 154 citations in OpenAlex.

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  19. Exploring theFrontiers in immunology · 2025
    Article
  20. Identification ofFrontiers in immunology · 2025
    Article

29 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

27 authors at 7 institutions in 6 countries.

Benjamin MordmüllerInstitut für Tropenmedizin, Universitätsklinikum Tübingen and Deutsches Zentrum für Infektionsforschung, Germany.
Mihály SulyokInstitut für Tropenmedizin, Universitätsklinikum Tübingen and Deutsches Zentrum für Infektionsforschung, Germany.
Diane Egger-AdamInstitut für Tropenmedizin, Universitätsklinikum Tübingen and Deutsches Zentrum für Infektionsforschung, Germany.
Mafalda ResendeCentre for Medical Parasitology at Department of Immunology and Microbiology, University of Copenhagen and Department of Infectious Diseases, Copenhagen University Hospital.
Willem A de JonghExpreS2ion Biotechnologies, Horsholm, Denmark.
Mette H JensenCentre for Medical Parasitology at Department of Immunology and Microbiology, University of Copenhagen and Department of Infectious Diseases, Copenhagen University Hospital.
Helle Holm SmedegaardCentre for Medical Parasitology at Department of Immunology and Microbiology, University of Copenhagen and Department of Infectious Diseases, Copenhagen University Hospital.
Sisse B DitlevCentre for Medical Parasitology at Department of Immunology and Microbiology, University of Copenhagen and Department of Infectious Diseases, Copenhagen University Hospital.
Max SoegaardExpreS2ion Biotechnologies, Horsholm, Denmark.
Lars PoulsenExpreS2ion Biotechnologies, Horsholm, Denmark.
Charlotte DyringExpreS2ion Biotechnologies, Horsholm, Denmark.
Carlos Lamsfus CalleInstitut für Tropenmedizin, Universitätsklinikum Tübingen and Deutsches Zentrum für Infektionsforschung, Germany.
Annette KnoblichInstitut für Tropenmedizin, Universitätsklinikum Tübingen and Deutsches Zentrum für Infektionsforschung, Germany.
Javier IbáñezInstitut für Tropenmedizin, Universitätsklinikum Tübingen and Deutsches Zentrum für Infektionsforschung, Germany.
Meral EsenInstitut für Tropenmedizin, Universitätsklinikum Tübingen and Deutsches Zentrum für Infektionsforschung, Germany.
Philippe DeloronMère et Enfant face aux Infections Tropicales, Institut de Recherche pour le Développement, Université Paris 5, Sorbonne Paris Cité, France.
Nicaise NdamMère et Enfant face aux Infections Tropicales, Institut de Recherche pour le Développement, Université Paris 5, Sorbonne Paris Cité, France.
Saadou IssifouFondation pour la Recherche Scientifique and Institut de Recherche Clinique du Bénin, Cotonou.
Sophie HouardEuropean Vaccine Initiative, Heidelberg, Germany.
Randall F HowardInfectious Disease Research Institute, Seattle, Washington.
Steven G ReedInfectious Disease Research Institute, Seattle, Washington.
Odile LeroyEuropean Vaccine Initiative, Heidelberg, Germany.
Adrian J F LutyMère et Enfant face aux Infections Tropicales, Institut de Recherche pour le Développement, Université Paris 5, Sorbonne Paris Cité, France.
Thor G TheanderCentre for Medical Parasitology at Department of Immunology and Microbiology, University of Copenhagen and Department of Infectious Diseases, Copenhagen University Hospital.
Peter G KremsnerInstitut für Tropenmedizin, Universitätsklinikum Tübingen and Deutsches Zentrum für Infektionsforschung, Germany.
Ali SalantiCentre for Medical Parasitology at Department of Immunology and Microbiology, University of Copenhagen and Department of Infectious Diseases, Copenhagen University Hospital.
Morten A NielsenCentre for Medical Parasitology at Department of Immunology and Microbiology, University of Copenhagen and Department of Infectious Diseases, Copenhagen University Hospital.
Universitätsklinikum Tübingen · DEUniversity of Copenhagen · DKExpreS2ion Biotechnologies (Denmark) · DKUniversité Paris Cité · FRInfectious Disease Research Institute · USVienna Vaccine Safety Initiative · DENational Research Fund Luxembourg · LU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMalaria in pregnancy has major impacts on mother and child health. To complement existing interventions, such as intermittent preventive treatment and use of impregnated bed nets, we developed a malaria vaccine candidate with the aim of reducing sequestration of asexual "blood-stage" parasites in the placenta, the major virulence mechanism.

methodsThe vaccine candidate PAMVAC is based on a recombinant fragment of VAR2CSA, the Plasmodium falciparum protein responsible for binding to the placenta via chondroitin sulfate A (CSA). Healthy, adult malaria-naive volunteers were immunized with 3 intramuscular injections of 20 μg (n = 9) or 50 μg (n = 27) PAMVAC, adjuvanted with Alhydrogel or glucopyranosyl lipid adjuvant in stable emulsion (GLA-SE) or in a liposomal formulation with QS21 (GLA-LSQ). Allocation was random and double blind. The vaccine was given every 4 weeks. Volunteers were observed for 6 months following last immunization.

resultsAll PAMVAC formulations were safe and well tolerated. A total of 262 adverse events (AEs) occurred, 94 (10 grade 2 and 2 grade 3) at least possibly related to the vaccine. No serious AEs occurred. Distribution and severity of AEs were similar in all arms. PAMVAC was immunogenic in all participants. PAMVAC-specific antibody levels were highest with PAMVAC-GLA-SE. The antibodies inhibited binding of VAR2CSA expressing P. falciparum-infected erythrocytes to CSA in a standardized functional assay.

conclusionsPAMVAC formulated with Alhydrogel or GLA-based adjuvants was safe, well tolerated, and induced functionally active antibodies. Next, PAMVAC will be assessed in women before first pregnancies in an endemic area. CLINICAL TRIALS REGISTRATION: EudraCT 2015-001827-21; ClinicalTrials.gov NCT02647489.

Indexed as

AdultAluminum HydroxideChondroitin SulfatesDouble-Blind MethodFemaleHumansInjections, IntramuscularLiposomesMalaria VaccinesPlasmodium falciparumPregnancyYoung AdultAluminum HydroxideChondroitin SulfatesLiposomesMalaria Vaccinesfirst-in-humanmalaria vaccinephase 1 clinical trialpregnancy-associated malariaVAR2CSA

Identifiers

PMID30629148
PMCPMC6792113
OpenAlexW2910623818

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.