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A pilot, phase I study tested the safety and feasibility of a prime-boost immunization regimen based on V935, an adenoviral type 6 vector vaccine expressing a modified version of hTERT, administered alone or in combination with V934, a DNA plasmid that also expresses the same antigen and is delivered using the electroporation injection technique.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Methods<\/jats:title>\n<jats:p>Treatments: Group #1 received two doses (low-dose: 0.5\u2009\u00d7\u200910<jats:sup>9<\/jats:sup> vg, and high-dose: 0.5\u2009\u00d7\u200910<jats:sup>11<\/jats:sup> vg) of V935 followed by a 4-week observation period. Group #2 received three doses of V934-electroporation and two doses of V935 following a 4-week observation period. Doses were low-dose V934 (0.25\u00a0mg of plasmid) with low-dose V935 (0.5\u2009\u00d7\u200910<jats:sup>9<\/jats:sup> vg); high-dose V934 (2.5\u00a0mg of plasmid) with high-dose V935 (0.5\u2009\u00d7\u200910<jats:sup>11<\/jats:sup> vg). Group #3 received five doses of V934-EP and two doses of V935: V934 was administered IM every 2\u00a0weeks for five doses. Following a 4-week observation period, V935 was administered IM every 2\u00a0weeks for two doses followed by a 4-week observation period. One (1) dose level was tested in treatment group #3: high-dose V934 (2.5\u00a0mg of plasmid), in combination with high-dose V935 (0.5\u2009\u00d7\u20091011 vg). Immunogenicity was measured by ELISPOT assay and three pools of peptides encompassing the sequence of hTERT.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Results<\/jats:title>\n<jats:p>In total, 37 patients affected by solid tumors (prostate cancer in 38%) were enrolled. The safety profile of different regimens was good and comparable across groups, with no severe adverse events, dose-limiting toxicities or treatment discontinuations. As expected, the most common adverse events were local reactions. A significant increase in ELISPOT responses against hTERT peptide pool 2 was observed (p\u2009&lt;\u20090.01), while no evidence of boosting was observed for peptide pools 1 and 3. This was also evident for group #1 and #2 separately. In patients with prostate cancer, there was a significant increase in ELISPOT response against hTERT peptide pool 2 following immunization (p\u2009&lt;\u20090.01), regardless of previous therapy, immunosuppressing agents, or adenoviral type 6 titers at screening.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Conclusion<\/jats:title>\n<jats:p>Our results suggest the safety and feasibility of V934\/V935 hTERT vaccination in cancer patients with solid tumors<\/jats:p>\n<jats:p><jats:italic>Trial Registration<\/jats:italic> Name of the registry: ClinicalTrial.gov Trial registration number: NCT00753415 Date of registration: 16 September 2008 Retrospectively registered URL of trial registry record: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/results?cond=&amp;term=NCT00753415&amp;cntry=&amp;state=&amp;city=&amp;dist=\">https:\/\/clinicaltrials.gov\/ct2\/results?cond=&amp;term=NCT00753415&amp;cntry=&amp;state=&amp;city=&amp;dist=<\/jats:ext-link><\/jats:p>\n<\/jats:sec>","DOI":"10.1186\/s12967-020-02228-9","type":"journal-article","created":{"date-parts":[[2020,1,30]],"date-time":"2020-01-30T13:03:13Z","timestamp":1580389393000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":29,"title":["Safety, tolerability and immunogenicity of V934\/V935 hTERT vaccination in cancer patients with selected solid tumors: a phase I study"],"prefix":"10.1186","volume":"18","clinical-trial-number":[{"clinical-trial-number":"nct00753415","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Luigi","family":"Aurisicchio","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arthur","family":"Fridman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Mauro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rose","family":"Sheloditna","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alberto","family":"Chiappori","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ansuman","family":"Bagchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gennaro","family":"Ciliberto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,1,30]]},"reference":[{"issue":"10","key":"2228_CR1","doi-asserted-by":"publisher","first-page":"e1488564","DOI":"10.1080\/2162402X.2018.1488564","volume":"7","author":"M Tagliamonte","year":"2018","unstructured":"Tagliamonte M, Petrizzo A, Mauriello A, Tornesello ML, Buonaguro FM, Buonaguro L. 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Luigi Aurisicchio and Gennaro Ciliberto were both employees of IRBM P. Angeletti, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA at the time of the study (2006\u20132009) and may own stock in the company. They both contributed to the initial generation of the V934\/V935 vaccine. Alberto Chiappori is on the speaker bureau of Genentech, Celgene, Takeda and Merck; is on the Ad Board of BMS, Astra Zeneca, Amgen, AbbVie and Pfizer; and has received research funding from BMS, Astra Zeneca and Novartis.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"39"}}