{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,22]],"date-time":"2026-08-22T14:24:05Z","timestamp":1787408645825,"version":"build-2736575974"},"reference-count":25,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T00:00:00Z","timestamp":1786492800000},"content-version":"vor","delay-in-days":11,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Malaria remains a significant global health burden, particularly among pediatric populations in endemic regions. Recent advances in preventive interventions highlight the complementary roles of vaccines and long\u2010acting monoclonal antibodies (mAbs) in reducing infection risk. Vaccines such as RTS,S\/AS01 and R21\/Matrix\u2010M induce active immunity through polyclonal antibody and CD4\n                    <jats:sup>+<\/jats:sup>\n                    T\u2010cell responses against the circumsporozoite protein (CSP), providing durable, population\u2010level protection. In contrast, mAbs including CIS43LS and L9LS confer immediate, passive immunity, with protection directly linked to systemic exposure and duration above protective thresholds. Translational pharmacokinetic\/pharmacodynamic (PK\/PD) modeling and physiologically based pharmacokinetic (PBPK) approaches are central to optimizing these interventions. Population PK models, combined with controlled human malaria infection (CHMI) studies, enable model\u2010informed selection of dose, route, and timing to achieve efficacious exposures, while PBPK models facilitate extrapolation to pediatric and special populations by incorporating developmental physiology, protein turnover, and FcRn\u2010mediated recycling. Clinical studies demonstrate robust protection from both vaccines and mAbs, supporting complementary combination strategies. Forward\u2010looking approaches integrate vaccines and long\u2010acting mAbs to leverage broad, durable immunity from vaccines and immediate, predictable protection from antibodies, particularly during seasonal peaks or in high\u2010risk groups. This review emphasizes how quantitative PK\/PD and PBPK modeling provide a framework to optimize dosing, predict durability of protection, and guide clinical development across diverse populations. These strategies underscore the value of model\u2010informed translational pharmacology in accelerating development of next\u2010generation malaria preventive interventions against malaria.\n                  <\/jats:p>","DOI":"10.1111\/cts.70704","type":"journal-article","created":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T04:22:19Z","timestamp":1786594939000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Quantitative and Clinical Pharmacology Perspectives on Next\u2010Generation Malaria Prevention Using Vaccines and Long\u2010Acting Monoclonal Antibodies"],"prefix":"10.1111","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-9359-8527","authenticated-orcid":false,"given":"Sabiha R.","family":"Mim","sequence":"first","affiliation":[{"name":"Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy University of Florida  Orlando Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3101-4814","authenticated-orcid":false,"given":"Leonardo C.","family":"Xavier","sequence":"additional","affiliation":[{"name":"Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy University of Florida  Orlando Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3625-0186","authenticated-orcid":false,"given":"Francine J.","family":"Azeredo","sequence":"additional","affiliation":[{"name":"Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy University of Florida  Orlando Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9794-8601","authenticated-orcid":false,"given":"Sihem","family":"Ait\u2010Oudhia","sequence":"additional","affiliation":[{"name":"Quantitative Pharmacology and Pharmacometrics (QP2), Merck &amp; Co., Inc  Rahway New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,8,12]]},"reference":[{"key":"e_1_2_12_2_1","unstructured":"Monoclonal antibody prevents malaria infection in African adults | National Institutes of Health (NIH) (2022) https:\/\/www.nih.gov\/news\u2010events\/news\u2010releases\/monoclonal\u2010antibody\u2010prevents\u2010malaria\u2010infection\u2010african\u2010adults."},{"key":"e_1_2_12_3_1","unstructured":"World Health Organization \u201cMalaria \u201d(2024) https:\/\/www.who.int\/news\u2010room\/fact\u2010sheets\/detail\/malaria."},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2025.127971"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1128\/cmr.00071-23"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1146\/annurev-micro-090817-062427"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1001685"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)60721-8"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2034031"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2238"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(21)00943-0"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2312775"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2203067"},{"key":"e_1_2_12_14_1","unstructured":"National Institute of Allergy and Infectious Diseases (NIAID) \u201cPhase 1 Dose Escalating Double\u2010Blind Randomized Comparator Controlled Trial of the Safety andImmunogenicity of Pfs25M\u2010EPA\/AS01 and Pfs230D1M\u2010EPA\/AS01 Vaccines Transmission Blocking Vaccines Against Plasmodium Falciparum at Full and Fractional Dosing in Adults in Mali \u201d(2024) https:\/\/clinicaltrials.gov\/study\/NCT02942277."},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0061395"},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(23)02511-4"},{"key":"e_1_2_12_17_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01285-13"},{"key":"e_1_2_12_18_1","doi-asserted-by":"publisher","DOI":"10.1038\/nature13612"},{"key":"e_1_2_12_19_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-025-03739-y"},{"key":"e_1_2_12_20_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms232112754"},{"key":"e_1_2_12_21_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40272-020-00382-7"},{"key":"e_1_2_12_22_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00287-13"},{"key":"e_1_2_12_23_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12936-024-04959-2"},{"key":"e_1_2_12_24_1","doi-asserted-by":"publisher","DOI":"10.3390\/pharmaceutics15051552"},{"key":"e_1_2_12_25_1","doi-asserted-by":"publisher","DOI":"10.1208\/s12248-025-01179-7"},{"key":"e_1_2_12_26_1","doi-asserted-by":"publisher","DOI":"10.3390\/pharmaceutics17070884"}],"container-title":["Clinical and Translational Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cts.70704","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/cts.70704","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cts.70704","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,22]],"date-time":"2026-08-22T13:38:01Z","timestamp":1787405881000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1111\/cts.70704"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8]]},"references-count":25,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2026,8]]}},"alternative-id":["10.1111\/cts.70704"],"URL":"https:\/\/doi.org\/10.1111\/cts.70704","archive":["Portico"],"relation":{},"ISSN":["1752-8054","1752-8062"],"issn-type":[{"value":"1752-8054","type":"print"},{"value":"1752-8062","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8]]},"assertion":[{"value":"2026-04-07","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-07-31","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-08-12","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70704"}}