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  1. AU="Reiber, Matthew"
  2. AU="Bauer-Rowe, Khristian E"
  3. AU="Tanner, Martin E"
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  6. AU="Munt, Jennifer E"
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Artikel ; Online: Subcutaneous Administration of a Monoclonal Antibody to Prevent Malaria.

Kayentao, Kassoum / Ongoiba, Aissata / Preston, Anne C / Healy, Sara A / Hu, Zonghui / Skinner, Jeff / Doumbo, Safiatou / Wang, Jing / Cisse, Hamidou / Doumtabe, Didier / Traore, Abdrahamane / Traore, Hamadi / Djiguiba, Adama / Li, Shanping / Peterson, Mary E / Telscher, Shinyi / Idris, Azza H / Adams, William C / McDermott, Adrian B /
Narpala, Sandeep / Lin, Bob C / Serebryannyy, Leonid / Hickman, Somia P / McDougal, Andrew J / Vazquez, Sandra / Reiber, Matthew / Stein, Judy A / Gall, Jason G / Carlton, Kevin / Schwabl, Philipp / Traore, Siriman / Keita, Mamadou / Zéguimé, Amatigué / Ouattara, Adama / Doucoure, M'Bouye / Dolo, Amagana / Murphy, Sean C / Neafsey, Daniel E / Portugal, Silvia / Djimdé, Abdoulaye / Traore, Boubacar / Seder, Robert A / Crompton, Peter D

The New England journal of medicine

2024  Band 390, Heft 17, Seite(n) 1549–1559

Abstract: Background: Subcutaneous administration of the monoclonal antibody L9LS protected adults against controlled : Methods: We conducted a phase 2 trial in Mali to assess the safety and efficacy of subcutaneous administration of L9LS in children 6 to 10 ... ...

Abstract Background: Subcutaneous administration of the monoclonal antibody L9LS protected adults against controlled
Methods: We conducted a phase 2 trial in Mali to assess the safety and efficacy of subcutaneous administration of L9LS in children 6 to 10 years of age over a 6-month malaria season. In part A of the trial, safety was assessed at three dose levels in adults, followed by assessment at two dose levels in children. In part B of the trial, children were randomly assigned, in a 1:1:1 ratio, to receive 150 mg of L9LS, 300 mg of L9LS, or placebo. The primary efficacy end point, assessed in a time-to-event analysis, was the first
Results: No safety concerns were identified in the dose-escalation part of the trial (part A). In part B, 225 children underwent randomization, with 75 children assigned to each group. No safety concerns were identified in part B.
Conclusions: Subcutaneous administration of L9LS to children was protective against
Mesh-Begriff(e) Adult ; Child ; Female ; Humans ; Male ; Dose-Response Relationship, Drug ; Double-Blind Method ; Endemic Diseases/prevention & control ; Injections, Subcutaneous ; Kaplan-Meier Estimate ; Malaria, Falciparum/drug therapy ; Malaria, Falciparum/epidemiology ; Malaria, Falciparum/prevention & control ; Mali/epidemiology ; Plasmodium falciparum ; Treatment Outcome ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antibodies, Monoclonal, Humanized/adverse effects ; Antibodies, Monoclonal, Humanized/therapeutic use ; Directly Observed Therapy ; Artemether, Lumefantrine Drug Combination/administration & dosage ; Artemether, Lumefantrine Drug Combination/therapeutic use ; Young Adult ; Middle Aged
Chemische Substanzen Antibodies, Monoclonal, Humanized ; Artemether, Lumefantrine Drug Combination
Sprache Englisch
Erscheinungsdatum 2024-04-26
Erscheinungsland United States
Dokumenttyp Journal Article ; Randomized Controlled Trial ; Clinical Trial, Phase II ; Research Support, Non-U.S. Gov't ; Multicenter Study ; Research Support, N.I.H., Extramural
ZDB-ID 207154-x
ISSN 1533-4406 ; 0028-4793
ISSN (online) 1533-4406
ISSN 0028-4793
DOI 10.1056/NEJMoa2312775
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Ua VI Zs.34: Hefte anzeigen Standort:
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Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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