Artikel ; Online: Subcutaneous Administration of a Monoclonal Antibody to Prevent Malaria.
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 |
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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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Datenquelle | MEDical Literature Analysis and Retrieval System OnLINE |
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