{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,5]],"date-time":"2026-11-05T19:11:27Z","timestamp":1793905887260,"version":"4.8.0"},"reference-count":43,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,4,23]],"date-time":"2024-04-23T00:00:00Z","timestamp":1713830400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,4,23]],"date-time":"2024-04-23T00:00:00Z","timestamp":1713830400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100010676","name":"H2020 Societal Challenges","doi-asserted-by":"publisher","award":["733273"],"award-info":[{"award-number":["733273"]}],"id":[{"id":"10.13039\/100010676","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Med"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>The stalling global progress in malaria control highlights the need for novel tools for malaria elimination, including transmission-blocking vaccines. Transmission-blocking vaccines aim to induce human antibodies that block parasite development in the mosquito and mosquitoes becoming infectious. The Pfs48\/45 protein is a leading <jats:italic>Plasmodium falciparum<\/jats:italic> transmission-blocking vaccine candidate. The R0.6C fusion protein, consisting of Pfs48\/45 domain 3 (6C) and the N-terminal region of <jats:italic>P. falciparum<\/jats:italic> glutamate-rich protein (R0), has previously been produced in <jats:italic>Lactococcus lactis<\/jats:italic> and elicited functional antibodies in rodents. Here, we assess the safety and transmission-reducing efficacy of R0.6C adsorbed to aluminium hydroxide with and without Matrix-M\u2122 adjuvant in humans.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>In this first-in-human, open-label clinical trial, malaria-na\u00efve adults, aged 18\u201355\u00a0years, were recruited at the Radboudumc in Nijmegen, the Netherlands. Participants received four intramuscular vaccinations on days 0, 28, 56 and 168 with either 30\u00a0\u00b5g or 100\u00a0\u00b5g of R0.6C and were randomised for the allocation of one of the two different adjuvant combinations: aluminium hydroxide alone, or aluminium hydroxide combined with Matrix-M1\u2122 adjuvant. Adverse events were recorded from inclusion until 84\u00a0days after the fourth vaccination. Anti-R0.6C and anti-6C IgG titres were measured by enzyme-linked immunosorbent assay. Transmission-reducing activity of participants\u2019 serum and purified vaccine-specific immunoglobulin G was assessed by standard membrane feeding assays using laboratory-reared <jats:italic>Anopheles stephensi<\/jats:italic> mosquitoes and cultured <jats:italic>P. falciparum<\/jats:italic> gametocytes.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Thirty-one participants completed four vaccinations and were included in the analysis. Administration of all doses was safe and well-tolerated, with one related grade 3 adverse event (transient fever) and no serious adverse events occurring. Anti-R0.6C and anti-6C IgG titres were similar between the 30 and 100\u00a0\u00b5g R0.6C arms, but higher in Matrix-M1\u2122 arms. Neat participant sera did not induce significant transmission-reducing activity in mosquito feeding experiments, but concentrated vaccine-specific IgGs purified from sera collected two weeks after the fourth vaccination achieved up to 99% transmission-reducing activity.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>R0.6C\/aluminium hydroxide with or without Matrix-M1\u2122 is safe, immunogenic and induces functional Pfs48\/45-specific transmission-blocking antibodies, albeit at insufficient serum concentrations to result in transmission reduction by neat serum. Future work should focus on identifying alternative vaccine formulations or regimens that enhance functional antibody responses.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>The trial is registered with ClinicalTrials.gov under identifier NCT04862416.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12916-024-03379-y","type":"journal-article","created":{"date-parts":[[2024,4,23]],"date-time":"2024-04-23T00:01:23Z","timestamp":1713830483000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["A Pfs48\/45-based vaccine to block Plasmodium falciparum transmission: phase 1, open-label, clinical trial"],"prefix":"10.1186","volume":"22","author":[{"given":"M.","family":"Alkema","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. 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