{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T06:35:57Z","timestamp":1787726157104,"version":"build-2784847793"},"reference-count":53,"publisher":"MDPI AG","issue":"11","license":[{"start":{"date-parts":[[2025,10,28]],"date-time":"2025-10-28T00:00:00Z","timestamp":1761609600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"AIVITA Biomedical, Inc., Irvine, CA, USA"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>Background\/Objectives: Dendritic cell vaccines are a promising cancer immunotherapy. AV-OVA-1 is a patient-specific vaccine consisting of autologous dendritic cells (DCs) loaded with autologous tumor antigens (ATA) from a lysate of irradiated self-renewing cells enriched for tumor-initiating cells (TICs). A multicenter, double-blind, randomized phase 2 trial was designed to determine manufacturing feasibility, safety, and efficacy. Methods: Patients had newly diagnosed stage 3 or 4 ovarian cancer. Short-term cell cultures were established from freshly resected tumor specimens. Patients were screened for randomization seven months after initial diagnosis, after completing neoadjuvant and\/or adjuvant chemotherapy and surgery. Eligibility included a successful cell culture, cryopreservation of sufficient monocyte numbers for differentiation into DCs, and good performance status. Patients were stratified by whether they had persistent disease; then, they were randomized 2:1 to AV-OVA-1 or autologous monocytes (MC). Cryopreserved doses of AV-OVA-1 and MC were thawed and admixed with granulocyte\u2013macrophage colony-stimulating factor just before subcutaneous injections at weeks 1, 2, 3, 8, 12, 16, 20, and 24. Results: Study accrual was terminated early during the SARS-CoV-2 pandemic. Manufacturing success rates for TICs, monocyte intermediate products, and AV-OVA-1 were 70\/72 (97.2%) and 47\/50 (94.0%), and 29\/30 (96.7%), respectively. A total of 29 participants were treated with AV-OVA-1 and 15 with MC. Patients received an average of 7.4 injections. Adverse-event frequencies were similar in both arms, mild to moderate in severity, and self-limited. T-cell immune responses increased only after AV-OVA-1. There were no survival differences in this underpowered study. Conclusions: AV-OVA-1 was manufactured reliably and injections were well tolerated.<\/jats:p>","DOI":"10.3390\/vaccines13111099","type":"journal-article","created":{"date-parts":[[2025,10,28]],"date-time":"2025-10-28T09:16:07Z","timestamp":1761642967000},"page":"1099","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Double-Blind Randomized Phase 2 Trial Testing Personal Cancer Vaccines in Patients with Advanced Ovarian Cancer"],"prefix":"10.3390","volume":"13","author":[{"given":"Lisa N.","family":"Abaid","sequence":"first","affiliation":[{"name":"Hoag Hospital Gynecologic Oncology, Newport Beach, CA 92663, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bradley R.","family":"Corr","sequence":"additional","affiliation":[{"name":"University of Colorado Cancer Center, Aurora, CO 80045, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramez N.","family":"Eskander","sequence":"additional","affiliation":[{"name":"University of California San Diego Moores Cancer Center, La Jolla, CA 92037, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James R.","family":"Mason","sequence":"additional","affiliation":[{"name":"Scripps Clinic, La Jolla, CA 92121, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katrina L.","family":"Lopez","sequence":"additional","affiliation":[{"name":"AIVITA Biomedical, Inc., Irvine, CA 92612, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Krystal","family":"Godding","sequence":"additional","affiliation":[{"name":"AIVITA Biomedical, Inc., Irvine, CA 92612, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rockelle M.","family":"Robles","sequence":"additional","affiliation":[{"name":"AIVITA Biomedical, Inc., Irvine, CA 92612, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hans S.","family":"Keirstead","sequence":"additional","affiliation":[{"name":"AIVITA Biomedical, Inc., Irvine, CA 92612, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriel I.","family":"Nistor","sequence":"additional","affiliation":[{"name":"AIVITA Biomedical, Inc., Irvine, CA 92612, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2975-926X","authenticated-orcid":false,"given":"Robert O.","family":"Dillman","sequence":"additional","affiliation":[{"name":"AIVITA Biomedical, Inc., Irvine, CA 92612, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,10,28]]},"reference":[{"key":"ref_1","first-page":"209","article-title":"Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries","volume":"71","author":"Sung","year":"2021","journal-title":"CA Cancer J. 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