ArticleOncology research and treatment2024
Intradermal Naked DNA Vaccination by DNA Tattooing for Mounting Tumor-Specific Immunity in Stage IV Melanoma Patients: A Phase I Clinical Trial.
Article in Oncology research and treatment, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Who cites it
5 citing papers in PubMed.
- Review
- Physical and Chemical Methods for DNA Vaccine Delivery: Insights into the Melanoma Landscape.Molecular biotechnology · 2026Review
- Therapeutic melanoma vaccines: Platforms, neoantigen strategies, and emerging combination immunotherapies.Therapeutic advances in vaccines and immunotherapy · 2026Review
- A Milestone in the Shift from "Passive Killing" to "Active Immunomodulation" in Cancer Treatment-Progress in Melanoma Vaccine Research.Current treatment options in oncology · 2025Review
- Clinical Translation Challenges and Strategies for Tumour Vaccines Considering Multiple Delivery Routes.Vaccines · 2025Review
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionNaked DNA vaccination could be a powerful and safe strategy to mount antigen-specific cellular immunity. We designed a phase I clinical trial to investigate the toxicity of naked DNA vaccines encoding CD8+ T-cell epitope from tumor-associated antigen MART-1 in patients with advanced melanoma.
methodsThis dose escalating phase Ia clinical trial investigates the toxicity and immunological response upon naked DNA vaccines encoding a CD8+ T-cell epitope from the tumor-associated antigen MART-1, genetically linked to the gene encoding domain 1 of subunit-tetanus toxin fragment C in patients with advanced melanoma (inoperable stage IIIC-IV, AJCC 7th edition). The vaccine was administrated via intradermal application using a permanent make-up or tattoo device. Safety was monitored according to CTCAE v.3.0 and skin biopsies and blood samples were obtained for immunologic monitoring.
resultsNine pretreated, HLA-A*0201-positive patients with advanced melanoma expressing MART-1 and MHC class I, with a good performance status, and adequate organ function, were included. With a median follow-up of 5.9 months, DNA vaccination was safe, without treatment-related deaths. Common treatment-emergent adverse events of any grade were dermatologic reactions at the vaccination site (100%) and pain (56%). One patient experienced grade 4 toxicity, most likely related to tumor progression. One patient (11%) achieved stable disease, lasting 353 days. Immune analysis showed no increase in vaccine-induced T cell response in peripheral blood of 5 patients, but did show a MART-1 specific CD8+ T cell response at the tattoo administration site. The maximum dose administered was 2 mg due to lack of clinical activity.
conclusionWe showed that the developed DNA vaccine, applied using a novel intradermal application strategy, can be administered safely. Further research with improved vaccine formats is required to show possible clinical benefit of DNA vaccination.
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