{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T23:41:24Z","timestamp":1791848484501,"version":"4.3.4"},"reference-count":37,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2024,2,8]],"date-time":"2024-02-08T00:00:00Z","timestamp":1707350400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"name":"T32 Fellowship Training Program in Vaccinology"},{"DOI":"10.13039\/100001949","name":"American Society of Tropical Medicine and Hygiene","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100001949","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100003240","name":"Passano Foundation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100003240","id-type":"DOI","asserted-by":"publisher"}]},{"name":"NIAID Malaria Vaccine Production Support Services"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,6,14]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Malaria is preventable yet causes &amp;gt;600 000 deaths annually. RTS,S, the first marketed malaria vaccine, has modest efficacy, but improvements are needed for eradication.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We conducted an open-label, dose escalation phase 1 study of a full-length recombinant circumsporozoite protein vaccine (rCSP) administered with adjuvant glucopyranosyl lipid A\u2013liposome Quillaja saponaria 21 formulation (GLA-LSQ) on days 1, 29, and 85 or 1 and 490 to healthy, malaria-naive adults. The primary end points were safety and reactogenicity. The secondary end points were antibody responses and Plasmodium falciparum parasitemia after homologous controlled human malaria infection.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Participants were enrolled into 4 groups receiving rCSP\/GLA-LSQ: 10\u2005\u00b5g \u00d7 3 (n = 20), 30\u2005\u00b5g \u00d7 3 (n = 10), 60\u2005\u00b5g \u00d7 3 (n = 10), or 60\u2005\u00b5g \u00d7 2 (n = 9); 10 participants received 30\u2005\u00b5g rCSP alone \u00d7 3, and there were 6 infectivity controls. Participants experienced no serious adverse events. Rates of solicited and unsolicited adverse events were similar among groups. All 26 participants who underwent controlled human malaria infection 28 days after final vaccinations developed malaria. Increasing vaccine doses induced higher immunoglobulin G titers but did not achieve previously established RTS,S benchmarks.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>rCSP\/GLA-LSQ had favorable safety results. However, tested regimens did not induce protective immunity. Further investigation could assess whether adjuvant or schedule adjustments improve efficacy.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trials Registration<\/jats:title>\n                  <jats:p>NCT03589794<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/infdis\/jiae062","type":"journal-article","created":{"date-parts":[[2024,2,8]],"date-time":"2024-02-08T21:54:04Z","timestamp":1707429244000},"page":"1883-1893","source":"Crossref","is-referenced-by-count":8,"title":["Recombinant Full-length <i>Plasmodium falciparum<\/i> Circumsporozoite Protein\u2013Based Vaccine Adjuvanted With Glucopyranosyl Lipid A\u2013Liposome <i>Quillaja saponaria<\/i> 21: Results of Phase 1 Testing With Malaria Challenge"],"prefix":"10.1093","volume":"229","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0373-4643","authenticated-orcid":false,"given":"DeAnna 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of Maryland School of Medicine , Baltimore, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Cox","sequence":"additional","affiliation":[{"name":"The Emmes Company , Rockville, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica","family":"Butts","sequence":"additional","affiliation":[{"name":"The Emmes Company , Rockville, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jordan S","family":"Lundeen","sequence":"additional","affiliation":[{"name":"The Emmes Company , Rockville, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathleen A","family":"Strauss","sequence":"additional","affiliation":[{"name":"Center for Vaccine Development and Global Health, University of Maryland School of Medicine , Baltimore, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sudhaunshu","family":"Joshi","sequence":"additional","affiliation":[{"name":"Center for Vaccine Development and Global Health, University of Maryland School of Medicine , Baltimore, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Biraj","family":"Shrestha","sequence":"additional","affiliation":[{"name":"Center for Vaccine Development and Global Health, University of Maryland School of Medicine , Baltimore, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annie X","family":"Mo","sequence":"additional","affiliation":[{"name":"Parasitology and International Programs Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health , Bethesda, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Effie Y H","family":"Nomicos","sequence":"additional","affiliation":[{"name":"Parasitology and International Programs Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health , Bethesda, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregory A","family":"Deye","sequence":"additional","affiliation":[{"name":"Parasitology and International Programs Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health , Bethesda, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason A","family":"Regules","sequence":"additional","affiliation":[{"name":"Biologics Research & Development, Walter Reed Army Institute of Research , Silver Spring, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elke 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