{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"institution":[{"name":"medRxiv"}],"indexed":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T18:16:51Z","timestamp":1787509011964,"version":"build-2736575974"},"posted":{"date-parts":[[2026,8,10]]},"group-title":"Allergy and Immunology","reference-count":31,"publisher":"openRxiv","license":[{"start":{"date-parts":[[2026,8,10]],"date-time":"2026-08-10T00:00:00Z","timestamp":1786320000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"2A Pharma AB"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"accepted":{"date-parts":[[2026,8,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                <jats:p>Seeking a simple vaccine to protect against all cancer-associated human papillomaviruses (HPV), L2 residues 17-36 of both HPV16 and HPV31 displayed on the surface of an Adeno-Associated Virus-Like Particle (AAVLP-HPV) was developed. Here, a phase 1 randomized, placebo-controlled, double-blind clinical study has been conducted in 20 male and female subjects at a single dose level (20\u00b5g) without an adjuvant. AAVLP-HPV vaccine administration was safe and well tolerated. Repeat vaccination with AAVLP-HPV elicited L2-specific neutralizing antibodies of modest titer in serum. Antibodies cross-reactive with L2 of diverse HPV types were detected, but responses were weak in most vaccinees. We conclude that while AAVLP-HPV vaccination is well tolerated, an adjuvant is likely needed to consistently elicit durable and broadly neutralizing responses.<\/jats:p>\n                <jats:sec>\n                  <jats:title>One sentence summary<\/jats:title>\n                  <jats:p>Vaccination with AAVLP-HPV is safe and immunogenic in healthy adults.<\/jats:p>\n                <\/jats:sec>\n                <jats:sec>\n                  <jats:title>Funding<\/jats:title>\n                  <jats:p>The study was funded by 2A Pharma AB. MM and RBSR were funded by service contracts from 2A Pharma AB. RBSR and JA were funded by Public Health Service (grants.nih.gov) grant P50 CA098252.<\/jats:p>\n                <\/jats:sec>","DOI":"10.64898\/2026.08.07.26359762","type":"posted-content","created":{"date-parts":[[2026,8,10]],"date-time":"2026-08-10T14:40:13Z","timestamp":1786372813000},"source":"Crossref","is-referenced-by-count":1,"title":["First-in-Human, Randomized, Placebo-Controlled, Double-Blind Phase 1 Study to Assess in Healthy Adults the Safety and Immunogenicity of Intramuscularly Administered AAVLP-HPV Vaccine"],"prefix":"10.64898","author":[{"given":"Jeanette","family":"Prangsgaard","sequence":"first","affiliation":[{"name":"2A Pharma AB, Sodergatan 3, 211 34 Malm\u00f6, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emma","family":"Huus","sequence":"additional","affiliation":[{"name":"2A Pharma AB, Sodergatan 3, 211 34 Malm\u00f6, Sweden"},{"name":"Aalborg University, Health Science and Technology, Selma Lagerl\u00f8fsvej 249, 9260 Gistrup, Denmark,"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jade","family":"Alvarez","sequence":"additional","affiliation":[{"name":"Department of Pathology, Johns Hopkins University, Baltimore, MD 21287, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard B.S.","family":"Roden","sequence":"additional","affiliation":[{"name":"Department of Pathology, Johns Hopkins University, Baltimore, MD 21287, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"M\u00fcller","sequence":"additional","affiliation":[{"name":"DKFZ, Immunology, Infection and Cancer, 60120 Heidelberg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qingxin","family":"Chen","sequence":"additional","affiliation":[{"name":"DKFZ, Immunology, Infection and Cancer, 60120 Heidelberg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Preben Bruun","family":"Nyzell","sequence":"additional","affiliation":[{"name":"2A Pharma AB, Sodergatan 3, 211 34 Malm\u00f6, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7423-0122","authenticated-orcid":false,"given":"John Dirk","family":"Vestergaard Nieland","sequence":"additional","affiliation":[{"name":"2A Pharma AB, Sodergatan 3, 211 34 Malm\u00f6, Sweden"},{"name":"Aalborg University, Health Science and Technology, Selma Lagerl\u00f8fsvej 249, 9260 Gistrup, Denmark,"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"54368","reference":[{"key":"2026081119200793000_2026.08.07.26359762v1.1","doi-asserted-by":"crossref","first-page":"124","DOI":"10.1186\/1475-2859-11-124","article-title":"Capsid protein expression and adeno-associated virus like particles assembly in Saccharomyces cerevisiae","volume":"11","year":"2012","journal-title":"Microb Cell Fact"},{"key":"2026081119200793000_2026.08.07.26359762v1.2","doi-asserted-by":"crossref","first-page":"541","DOI":"10.1097\/OLQ.0000000000000319","article-title":"Associations of Anogenital Low-Risk Human Papillomavirus Infection With Cancer and Acquisition of HIV","volume":"42","year":"2015","journal-title":"Sex Transm Dis"},{"key":"2026081119200793000_2026.08.07.26359762v1.3","doi-asserted-by":"publisher","DOI":"10.1016\/j.virol.2010.02.002"},{"key":"2026081119200793000_2026.08.07.26359762v1.4","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(09)70096-8"},{"key":"2026081119200793000_2026.08.07.26359762v1.5","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21492"},{"key":"2026081119200793000_2026.08.07.26359762v1.6","doi-asserted-by":"publisher","DOI":"10.1128\/JVI.69.6.3959-3963.1995"},{"key":"2026081119200793000_2026.08.07.26359762v1.7","doi-asserted-by":"publisher","DOI":"10.1016\/j.virol.2004.03.033"},{"key":"2026081119200793000_2026.08.07.26359762v1.8","doi-asserted-by":"publisher","DOI":"10.1002\/path.4065"},{"key":"2026081119200793000_2026.08.07.26359762v1.9","doi-asserted-by":"crossref","unstructured":"Grosse, S. , M. 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