Chemoprotective Antimalarial Activity of P218 against Plasmodium falciparum: A Randomized, Placebo-Controlled Volunteer Infection Study Article Swipe
Mohamed Farouk Chughlay
,
Myriam El Gaaloul
,
Cristina Donini
,
Brice Campo
,
Pieter-Jan Berghmans
,
Alexander Lucardie
,
Michael W. Marx
,
Mohammed H. Cherkaoui‐Rbati
,
Grant Langdon
,
Íñigo Angulo‐Barturen
,
Sara Viera
,
Anna Rosanas‐Urgell
,
Jean‐Pierre Van Geertruyden
,
Stephan Chalon
·
YOU?
·
· 2021
· Open Access
·
· DOI: https://doi.org/10.4269/ajtmh.20-1165
YOU?
·
· 2021
· Open Access
·
· DOI: https://doi.org/10.4269/ajtmh.20-1165
P218 is a highly selective dihydrofolate reductase inhibitor with potent in vitro activity against pyrimethamine-resistant Plasmodium falciparum . This single-center, randomized, double-blind, placebo-controlled phase Ib study evaluated P218 safety, pharmacokinetics, and chemoprotective efficacy in a P. falciparum sporozoite ( Pf SPZ) volunteer infection study (VIS). Consecutive dose safety and tolerability were evaluated (cohort 1), with participants receiving two oral doses of P218 1,000 mg 48 hours apart ( n = 6), or placebo ( n = 2). P218 chemoprotective efficacy was assessed (cohorts 2 and 3) with direct venous inoculation of 3,200 aseptic, cryopreserved Pf SPZ (NF54 strain) followed 2 hours later with two P218 doses of 1,000 mg (cohort 2, n = 9) or 100 mg (cohort 3, n = 9) administered 48 hours apart, or placebo ( n = 6). Parasitemia was assessed from day 7 using quantitative PCR targeting the var gene acidic terminal sequence (varATS qPCR). By day 28, all participants in cohort 2 (P218 1,000 mg) and 8/9 in cohort 3 (P218 100 mg) were sterilely protected post- Pf SPZ VIS, confirming P218 P. falciparum chemoprotective activity. With placebo, all six participants became parasitemic (geometric mean time to positive parasitemia 10.6 days [90% CI: 9.9–11.4]). P218 pharmacokinetics were similar in participants with or without induced infection. Adverse events of any cause occurred in 45.8% (11/24) of participants who received P218 and 50.0% (4/8) following placebo; all were mild/moderate in severity, transient, and self-limiting. There were no clinically relevant changes in laboratory parameters, vital signs, or electrocardiograms. P218 displayed excellent chemoprotective efficacy against P. falciparum with favorable safety and tolerability.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.4269/ajtmh.20-1165
- https://www.ajtmh.org/downloadpdf/journals/tpmd/104/4/article-p1348.pdf
- OA Status
- hybrid
- Cited By
- 29
- References
- 21
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W3127084640
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
-
https://openalex.org/W3127084640Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.4269/ajtmh.20-1165Digital Object Identifier
- Title
-
Chemoprotective Antimalarial Activity of P218 against Plasmodium falciparum: A Randomized, Placebo-Controlled Volunteer Infection StudyWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2021Year of publication
- Publication date
-
2021-02-08Full publication date if available
- Authors
-
Mohamed Farouk Chughlay, Myriam El Gaaloul, Cristina Donini, Brice Campo, Pieter-Jan Berghmans, Alexander Lucardie, Michael W. Marx, Mohammed H. Cherkaoui‐Rbati, Grant Langdon, Íñigo Angulo‐Barturen, Sara Viera, Anna Rosanas‐Urgell, Jean‐Pierre Van Geertruyden, Stephan ChalonList of authors in order
- Landing page
-
https://doi.org/10.4269/ajtmh.20-1165Publisher landing page
- PDF URL
-
https://www.ajtmh.org/downloadpdf/journals/tpmd/104/4/article-p1348.pdfDirect link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
hybridOpen access status per OpenAlex
- OA URL
-
https://www.ajtmh.org/downloadpdf/journals/tpmd/104/4/article-p1348.pdfDirect OA link when available
- Concepts
-
Tolerability, Medicine, Parasitemia, Placebo, Cohort, Plasmodium falciparum, Chemoprotective, Adverse effect, Internal medicine, Pharmacology, Gastroenterology, Immunology, Malaria, Cancer, Pathology, Alternative medicineTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
29Total citation count in OpenAlex
- Citations by year (recent)
-
2025: 2, 2024: 5, 2023: 11, 2022: 4, 2021: 7Per-year citation counts (last 5 years)
- References (count)
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21Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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| referenced_works | https://openalex.org/W2163472591, https://openalex.org/W2174747180, https://openalex.org/W2998839601, https://openalex.org/W2132730360, https://openalex.org/W2091490176, https://openalex.org/W2546422487, https://openalex.org/W2166476687, https://openalex.org/W2097452962, https://openalex.org/W2121482791, https://openalex.org/W2594245371, https://openalex.org/W2884611957, https://openalex.org/W2603629512, https://openalex.org/W798958370, https://openalex.org/W2811381381, https://openalex.org/W2024197152, https://openalex.org/W2800362720, https://openalex.org/W2773291920, https://openalex.org/W2170265923, https://openalex.org/W2057089852, https://openalex.org/W2114964953, https://openalex.org/W2130533265 |
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