Immune responses elicited by R21/Matrix-M™ malaria vaccine in children aged 5-36 months: robust one year durability and correlation between long-lived CSP-IgG and vaccine efficacy

Immune responses elicited by R21/Matrix-M™ malaria vaccine in children aged 5-36 months: robust one year durability and correlation between long-lived CSP-IgG and vaccine efficacy | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Article Immune responses elicited by R21/Matrix-M™ malaria vaccine in children aged 5-36 months: robust one year durability and correlation between long-lived CSP-IgG and vaccine efficacy Lisa Stockdale, Emma Beaumont, Samuel Provstgaard-Morys, Benedict Hollingdale, and 28 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8980000/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted You are reading this latest preprint version Abstract Malaria vaccines are a critical addition to global efforts to reduce disease burden, yet our understanding of the durability and immunologic mechanism of action across diverse endemic settings is limited. Here we evaluate humoral immune responses to four components of the R21/Matrix-M™ vaccine following a three-dose primary series and one booster dose administered a year later to children aged 5-36 months across five sites in four malaria-endemic African countries. Here we report robust induction of vaccine-specific antibodies after the primary series and booster dose of R21/Matrix-M™. Younger children aged 5-17 months had higher fold change from pre-vaccination to post-primary series for circumsporozoite protein (CSP)-specific IgG compared with 18-36 month olds (p<0.001) but there was no effect of age on the waning of antibodies in the first year. While baseline parasitemia was associated with higher pre-vaccination anti-CSP IgG titres (p<0.001), pre-vaccination CSP-specific antibodies did not impair the ability of the vaccine to elicit robust antibody responses. Both C-terminal CSP-specific and NANP-repeat IgG titres at 28 and 180 days after the primary series were associated with a reduction in the rate of clinical malaria in the R21/Matrix-MTM study arm. Notably, at one year following primary series, C-terminal CSP-specific IgG titres continued to be associated with a reduction in the rate of clinical malaria (IRR 0.32 (95% CI: 0.17, 0.61), underscoring its potential as a biomarker of vaccine-induced protection. Biological sciences/Immunology/Vaccines Biological sciences/Immunology/Infectious diseases/Malaria Full Text Additional Declarations Yes there is potential Competing Interest. Katie Ewer and Adrian Hill - Are named as a co-inventor on patent applications related to R21 and have personally received royalty payments for the R21 vaccine IP licensed to Serum Institute of India. Umesh Shaligram, Parag Nagarkar, Sandesh Bharati and Prasad S. Kulkarni are employees of Serum Institute of India Pvt. Ltd. , the manufacturer of R21 Malaria Vaccine Supplementary Files R21MatrixMTrialGroupAuthorsFeb2026.pdf R21/Matrix-M Trial Group Author List RSStockdale.pdf Reporting Summary Cite Share Download PDF Status: Under Review Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8980000","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":609627433,"identity":"00ccf52b-bae3-4602-a406-c8604c6dcb0a","order_by":0,"name":"Lisa 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List","description":"","filename":"R21MatrixMTrialGroupAuthorsFeb2026.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8980000/v1/e561221ee652637e05874577.pdf"},{"id":105186030,"identity":"34480179-73b0-4533-9cca-f2d5aad5d66a","added_by":"auto","created_at":"2026-03-23 08:35:28","extension":"pdf","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":3084612,"visible":true,"origin":"","legend":"Reporting Summary","description":"","filename":"RSStockdale.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8980000/v1/ea01542ed5cbdb1df7ac4a53.pdf"}],"financialInterests":"\u003cb\u003eYes\u003c/b\u003e there is potential Competing Interest.\nKatie Ewer and Adrian Hill - Are named as a co-inventor on patent applications related to R21 and have personally received royalty payments for the R21 vaccine IP licensed to Serum Institute of India. \r\nUmesh Shaligram, Parag Nagarkar, Sandesh Bharati and Prasad S. Kulkarni are employees of Serum Institute of India Pvt. Ltd. , the manufacturer of R21 Malaria Vaccine","formattedTitle":"\u003cp\u003eImmune responses elicited by R21/Matrix-M™ malaria vaccine in children aged 5-36 months: robust one year durability and correlation between long-lived CSP-IgG and vaccine efficacy\u003c/p\u003e","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"nature-portfolio","isNatureJournal":true,"hasQc":false,"allowDirectSubmit":false,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"","title":"Nature Portfolio","twitterHandle":"","acdcEnabled":false,"dfaEnabled":false,"editorialSystem":"ejp","reportingPortfolio":"","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-8980000/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8980000/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eMalaria vaccines are a critical addition to global efforts to reduce disease burden, yet our understanding of the durability and immunologic mechanism of action across diverse endemic settings is limited. Here we evaluate humoral immune responses to four components of the R21/Matrix-M™ vaccine following a three-dose primary series and one booster dose administered a year later to children aged 5-36 months across five sites in four malaria-endemic African countries.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eHere we report robust induction of vaccine-specific antibodies after the primary series and booster dose of R21/Matrix-M™. Younger children aged 5-17 months had higher fold change from pre-vaccination to post-primary series for circumsporozoite protein (CSP)-specific IgG compared with 18-36 month olds (p\u0026lt;0.001) but there was no effect of age on the waning of antibodies in the first year. While baseline parasitemia was associated with higher pre-vaccination anti-CSP IgG titres (p\u0026lt;0.001), pre-vaccination CSP-specific antibodies did not impair the ability of the vaccine to elicit robust antibody responses.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eBoth C-terminal CSP-specific and NANP-repeat IgG titres at 28 and 180 days after the primary series were associated with a reduction in the rate of clinical malaria in the R21/Matrix-MTM study arm. Notably, at one year following primary series, C-terminal CSP-specific IgG titres continued to be associated with a reduction in the rate of clinical malaria (IRR 0.32 (95% CI: 0.17, 0.61), underscoring its potential as a biomarker of vaccine-induced protection.\u003c/p\u003e","manuscriptTitle":"Immune responses elicited by R21/Matrix-M™ malaria vaccine in children aged 5-36 months: robust one year durability and correlation between long-lived CSP-IgG and vaccine efficacy","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-03-23 08:35:23","doi":"10.21203/rs.3.rs-8980000/v1","editorialEvents":[],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"nature-medicine","isNatureJournal":true,"hasQc":false,"allowDirectSubmit":false,"externalIdentity":"nm","sideBox":"Learn more about [Nature Medicine](http://www.nature.com/nm/)","snPcode":"","submissionUrl":"","title":"Nature Medicine","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"ejp","reportingPortfolio":"Nature Research","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"21cf2127-6da2-43e4-88c4-aea841d51cfb","owner":[],"postedDate":"March 23rd, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[{"id":64951736,"name":"Biological sciences/Immunology/Vaccines"},{"id":64951737,"name":"Biological sciences/Immunology/Infectious diseases/Malaria"}],"tags":[],"updatedAt":"2026-04-16T19:10:25+00:00","versionOfRecord":[],"versionCreatedAt":"2026-03-23 08:35:23","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8980000","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8980000","identity":"rs-8980000","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}