{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,17]],"date-time":"2026-04-17T06:01:45Z","timestamp":1776405705189,"version":"3.51.2"},"reference-count":39,"publisher":"BMJ","issue":"8","license":[{"start":{"date-parts":[[2021,8,2]],"date-time":"2021-08-02T00:00:00Z","timestamp":1627862400000},"content-version":"unspecified","delay-in-days":1,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100021821","name":"Oncode Institute","doi-asserted-by":"crossref","award":["n\/a"],"award-info":[{"award-number":["n\/a"]}],"id":[{"id":"10.13039\/501100021821","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Rational molecular Assessment Innovative Drug selection (RAIDs) consortium","award":["Grant No. 304810"],"award-info":[{"award-number":["Grant No. 304810"]}]},{"name":"Louise Vehmeijer Foundation, The Netherlands","award":["n\/a"],"award-info":[{"award-number":["n\/a"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J Immunother Cancer"],"accepted":{"date-parts":[[2021,7,13]]},"published-print":{"date-parts":[[2021,8]]},"abstract":"<jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Usual vulvar intraepithelial neoplasia (uVIN) is a premalignancy caused by persistent infection with high-risk types of human papillomavirus (HPV), mainly type 16. Even though different treatment modalities are available (eg, surgical excision, laser evaporation or topical application of imiquimod), these treatments can be mutilating, patients often have recurrences and 2%\u20138% of patients develop vulvar carcinoma. Therefore, immunotherapeutic strategies targeting the pivotal oncogenic HPV proteins E6 and E7 are being explored to repress carcinogenesis.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Method<\/jats:title>\n                  <jats:p>In this phase I\/II clinical trial, 14 patients with HPV16+ uVIN were treated with a genetically enhanced DNA vaccine targeting E6 and E7. Safety, clinical responses and immunogenicity were assessed. Patients received four intradermal HPV-16 E6\/E7 DNA tattoo vaccinations, with a 2-week interval, alternating between both upper legs. Biopsies of the uVIN lesions were taken at screening and +3 months after last vaccination. Digital photography of the vulva was performed at every check-up until 12 months of follow-up for measurement of the lesions. HPV16-specific T-cell responses were measured in blood over time in ex vivo reactivity assays.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Vaccinations were well tolerated, although one grade 3 suspected unexpected serious adverse reaction was observed. Clinical responses were observed in 6\/14 (43%) patients, with 2 complete responses and 4 partial responses (PR). 5\/14 patients showed HPV-specific T-cell responses in blood, measured in ex vivo reactivity assays. Notably, all five patients with HPV-specific T-cell responses had a clinical response.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Our results indicate that HPV-16 E6\/E7 DNA tattoo vaccination is a biologically active and safe treatment strategy in patients with uVIN, and suggest that T-cell reactivity against the HPV oncogenes is associated with clinical benefit.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>NTR4607.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/jitc-2021-002547","type":"journal-article","created":{"date-parts":[[2021,8,2]],"date-time":"2021-08-02T12:18:11Z","timestamp":1627906691000},"page":"e002547","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":15,"title":["HPV-16 E6\/E7 DNA tattoo vaccination using genetically optimized vaccines elicit clinical and immunological responses in patients with usual vulvar intraepithelial neoplasia (uVIN): a phase I\/II clinical trial"],"prefix":"10.1136","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7167-581X","authenticated-orcid":false,"given":"Noor Alida Maria","family":"Bakker","sequence":"first","affiliation":[{"name":"Division of Molecular Oncology & Immunology, The Netherlands Cancer Institute \u2013 Antoni van Leeuwenhoek, Amsterdam, The Netherlands"},{"name":"Division of Tumor Biology and Immunology, The Netherlands Cancer Institute \u2013 Antoni van Leeuwenhoek, Amsterdam, The Netherlands"},{"name":"Oncode Institute, Utrecht, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jossie","family":"Rotman","sequence":"additional","affiliation":[{"name":"Center for Gynecologic Oncology Amsterdam (CGOA), The Netherlands Cancer Institute \u2013 Antoni van Leeuwenhoek, Amsterdam, The Netherlands"},{"name":"Center for Gynecological Oncology Amsterdam (CGOA), Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marc","family":"van Beurden","sequence":"additional","affiliation":[{"name":"Center for Gynecologic Oncology Amsterdam (CGOA), The Netherlands Cancer Institute \u2013 Antoni van Leeuwenhoek, Amsterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Henry J MAA","family":"Zijlmans","sequence":"additional","affiliation":[{"name":"Center for Gynecologic Oncology Amsterdam (CGOA), The Netherlands Cancer Institute \u2013 Antoni van Leeuwenhoek, Amsterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maartje","family":"van Ruiten","sequence":"additional","affiliation":[{"name":"Center for Gynecologic Oncology Amsterdam (CGOA), The Netherlands Cancer Institute \u2013 Antoni van Leeuwenhoek, Amsterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sanne","family":"Samuels","sequence":"additional","affiliation":[{"name":"Center for Gynecologic Oncology Amsterdam (CGOA), The Netherlands Cancer Institute \u2013 Antoni van Leeuwenhoek, Amsterdam, The Netherlands"},{"name":"Center for Gynecological Oncology Amsterdam (CGOA), Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bastiaan","family":"Nuijen","sequence":"additional","affiliation":[{"name":"Department of Pharmacy and Pharmacology, The Netherlands Cancer Institute \u2013 Antoni van Leeuwenhoek, Amsterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jos","family":"Beijnen","sequence":"additional","affiliation":[{"name":"Department of Pharmacy and Pharmacology, The Netherlands Cancer Institute \u2013 Antoni van Leeuwenhoek, Amsterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karin","family":"De Visser","sequence":"additional","affiliation":[{"name":"Division of Tumor Biology and Immunology, The Netherlands Cancer Institute \u2013 Antoni van Leeuwenhoek, Amsterdam, The Netherlands"},{"name":"Oncode Institute, Utrecht, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Haanen","sequence":"additional","affiliation":[{"name":"Division of Molecular Oncology & Immunology, The Netherlands Cancer Institute \u2013 Antoni van Leeuwenhoek, Amsterdam, The Netherlands"},{"name":"Department of Medical Oncology, Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ton","family":"Schumacher","sequence":"additional","affiliation":[{"name":"Division of Molecular Oncology & Immunology, The Netherlands Cancer Institute \u2013 Antoni van Leeuwenhoek, Amsterdam, The Netherlands"},{"name":"Oncode Institute, Utrecht, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tanja D","family":"de Gruijl","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, \u2014Cancer Center Amsterdam, Amsterdam UMC\u2014Vrije Universiteit, Amsterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ekaterina S","family":"Jordanova","sequence":"additional","affiliation":[{"name":"Center for Gynecological Oncology Amsterdam (CGOA), Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gemma G","family":"Kenter","sequence":"additional","affiliation":[{"name":"Center for Gynecologic Oncology Amsterdam (CGOA), The Netherlands Cancer Institute \u2013 Antoni van Leeuwenhoek, Amsterdam, The Netherlands"},{"name":"Center for Gynecological Oncology Amsterdam (CGOA), Amsterdam UMC, Vrije Universiteit Amsterdam, 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