{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,6]],"date-time":"2026-03-06T06:09:55Z","timestamp":1772777395252,"version":"3.50.1"},"reference-count":40,"publisher":"MDPI AG","issue":"3","license":[{"start":{"date-parts":[[2025,3,11]],"date-time":"2025-03-11T00:00:00Z","timestamp":1741651200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Heber Biotec"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>Background: The therapeutic blockade of the PD1\/PD-L1 axis with monoclonal antibodies has led to a breakthrough in cancer treatment, as it plays a key role in the immune evasion of tumors. Nevertheless, treating patients with cancer with vaccines that stimulate a targeted immune response is another attractive approach for which few side effects have been observed in combination immunotherapy clinical trials. In this sense, our group has recently developed a therapeutic cancer vaccine candidate called PKPD-L1Vac which contains as an antigen the extracellular domain of human PD-L1 fused to a 47 amino-terminal, part of the LpdA gene of N. meningitides, which is produced in E. coli. The investigation of potential toxicities associated with PD-L1 blockade by a new therapy in preclinical studies is critical to optimizing the efficacy and safety of that new therapy. Methods: Here, we describe immunogenicity and preliminary safety studies in mice, rats, rabbits, and non-human primates that make use of a 200 \u03bcg dose of PKPD-L1 in combination with VSSPs or alum phosphate to contribute to the assessment of potential adverse events that are relevant to the future clinical development program of this novel candidate. Results: The administration of PKPD-L1Vac to the four species at the doses studied was immunogenic and did not result in behavioral, clinical, hematological, or serum biochemical changes. Conclusions: Therefore, PKPD-L1Vac could be considered suitable for further complex toxicological studies and the way for its clinical evaluation in humans has been opened.<\/jats:p>","DOI":"10.3390\/vaccines13030296","type":"journal-article","created":{"date-parts":[[2025,3,11]],"date-time":"2025-03-11T06:52:30Z","timestamp":1741675950000},"page":"296","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Immunogenicity and Safety Profile of Two Adjuvanted-PD-L1-Based Vaccine Candidates in Mice, Rats, Rabbits, and Cynomolgus Monkeys"],"prefix":"10.3390","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7592-0579","authenticated-orcid":false,"given":"Camila","family":"Cana\u00e1n-Haden","sequence":"first","affiliation":[{"name":"Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, Playa Cubanac\u00e1n, Havana 10600, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Javier","family":"S\u00e1nchez-Ram\u00edrez","sequence":"additional","affiliation":[{"name":"Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, Playa Cubanac\u00e1n, Havana 10600, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rafael","family":"Mart\u00ednez-Castillo","sequence":"additional","affiliation":[{"name":"Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, Playa Cubanac\u00e1n, Havana 10600, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0351-857X","authenticated-orcid":false,"given":"M\u00f3nica","family":"Bequet-Romero","sequence":"additional","affiliation":[{"name":"Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, Playa Cubanac\u00e1n, Havana 10600, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pedro","family":"Puente-P\u00e9rez","sequence":"additional","affiliation":[{"name":"Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, Playa Cubanac\u00e1n, Havana 10600, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7633-4769","authenticated-orcid":false,"given":"Isabel","family":"Gonzalez-Moya","sequence":"additional","affiliation":[{"name":"Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, Playa Cubanac\u00e1n, Havana 10600, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yunier","family":"Rodr\u00edguez-\u00c1lvarez","sequence":"additional","affiliation":[{"name":"Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, Playa Cubanac\u00e1n, Havana 10600, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marta","family":"Ayala-\u00c1vila","sequence":"additional","affiliation":[{"name":"Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, Playa Cubanac\u00e1n, Havana 10600, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jorge","family":"Castro-Velazco","sequence":"additional","affiliation":[{"name":"Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, Playa Cubanac\u00e1n, Havana 10600, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Olivia","family":"Cabanillas-Bernal","sequence":"additional","affiliation":[{"name":"CONAHCYT\u2014Innovation and Development Promotion Direction, Centro de Investigaci\u00f3n Cient\u00edfica y Educaci\u00f3n Superior de Ensenada (CICESE), Ensenada 22860, Mexico"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marco A.","family":"De-Le\u00f3n-Nava","sequence":"additional","affiliation":[{"name":"Biomedical Innovation Department, Centro de Investigaci\u00f3n Cient\u00edfica y Educaci\u00f3n Superior de Ensenada (CICESE), Ensenada 22860, Mexico"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4022-7405","authenticated-orcid":false,"given":"Alexei F.","family":"Licea-Navarro","sequence":"additional","affiliation":[{"name":"Biomedical Innovation Department, Centro de Investigaci\u00f3n Cient\u00edfica y Educaci\u00f3n Superior de Ensenada (CICESE), Ensenada 22860, Mexico"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6051-5514","authenticated-orcid":false,"given":"Yanelys","family":"Morera-D\u00edaz","sequence":"additional","affiliation":[{"name":"Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, Playa Cubanac\u00e1n, Havana 10600, Cuba"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2025,3,11]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","unstructured":"Munari, E., Mariotti, F.R., Quatrini, L., Bertoglio, P., Tumino, N., Vacca, P., Eccher, A., Ciompi, F., Brunelli, M., and Martignoni, G. (2021). PD-1\/PD-L1 in Cancer: Pathophysiological, Diagnostic and Therapeutic Aspects. Int. J. Mol. Sci., 22.","DOI":"10.3390\/ijms22105123"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"3625","DOI":"10.2147\/DDDT.S267433","article-title":"Research Status and Outlook of PD-1\/PD-L1 Inhibitors for Cancer Therapy","volume":"14","author":"Ai","year":"2020","journal-title":"Drug Des. Dev. 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