The DOI matches its Crossref record; 26 of the 28 references it cites were found in a registry or an index.
Direct Injection of Protamine-protected mRNA: Results of a Phase 1/2 Vaccination Trial in Metastatic Melanoma Patients
Abstract
In mice, injection of messenger RNA (mRNA) coding for tumor-associated antigens can induce antitumor immune responses and therefore offers a broadly applicable immunotherapy approach. We injected intradermally protamine-stabilized mRNAs coding for Melan-A, Tyrosinase, gp100, Mage-A1, Mage-A3, and Survivin in 21 metastatic melanoma patients. In 10 patients keyhole limpet hemocyanin (KLH) was added to the vaccine. Granulocyte macrophage colony-stimulating factor was applied as an adjuvant. Endpoints were toxicity and immune responses. No adverse events more than grade II have been observed. During treatment the frequency of Foxp3+/CD4+ regulatory T cells was significantly decreased upon mRNA vaccination in peripheral blood of the patients in the KLH arm, whereas myeloid suppressor cells (CD11b+HLA-DR lo monocytes) were reduced in the patients not receiving KLH. A reproducible increase of vaccine-directed T cells was observed in 2 of 4 immunologically evaluable patients. One of 7 patients with measurable disease showed a complete response. In conclusion, we show here that direct injection of protamine-protected mRNA is feasible and safe. The significant influence of the treatment on the frequency of immunosuppressive cells, the increase of vaccine-directed T cells upon treatment in a subset of patients together with the demonstration of a complete clinical response encourage further clinical investigation of the protamine-mRNA vaccine.
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“Various RNA vaccines have been evaluated in human clinical trials, including naked and formulated non-amplifying mRNA (37-39) and self-amplifying RNA packaged in VRPs (25).”
From Nonviral delivery of self-amplifying RNA vaccines (2012) · cites this paper as [39]
In the citing paper
“Those studies showed RNA vaccines to be well tolerated and immunogenic.”
From Nonviral delivery of self-amplifying RNA vaccines (2012) · cites this paper as [39]
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“We established that this vaccination approach is feasible and safe, but clinical or immunologic responses were inconclusive.(7,8) After this first clinical trial, the mRNA concept was modified for the study presented here, as follows: (1) we used 6 defined mRNAs encoding known melanoma-associated antigens (Melan-A, Ty…”
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Yang, R., He, J., Kang, D., Chen, Y., Huang, J., Li, J., Wang, X., & Zhou, S. (2025) · Frontiers in Immunology · doi:10.3389/fimmu.2025.1520505 · Cited by 4
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Metadata
- Authors
- Weide, B., Pascolo, S., Scheel, B., Derhovanessian, E., Pflugfelder, A., Eigentler, T. K., Pawelec, G., Hoerr, I., Rammensee, H.-G., & Garbe, C.
- Affiliations
- University of Tübingen (DE)
- CureVac (Germany) (DE)
- Corresponding author
- Weide, Benjamin
- Pflugfelder, Annette
- Eigentler, Thomas K.
- Garbe, Claus
- ORCID
- Venue
- Journal of Immunotherapy
- Published
- 2009-06
- Volume
- 32
- Issue
- 5
- Pages
- 498-507
- ISSN
- 1524-9557 (ISSN-L)
- OpenAlex
- W1966322307
- Cited by
- 378
- References
- 28
- Citations by year
- 2026: 15 · 2025: 31 · 2024: 29 · 2023: 45 · 2022: 45 · 2021: 40 · 2020: 22 · 2019: 14 · 2018: 19 · 2017: 16 · 2016: 14 · 2015: 16 · 2014: 17 · 2013: 12 · 2012: 13
- FWCI
- 6.18
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Immunotherapy (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Oncology › Cutaneous Melanoma Detection and Management
- Keywords
- mRNA vaccination, metastatic melanoma, tumor-associated antigens, Melan-A, tyrosinase, gp100, MAGE-1, MAGE-A3, survivin, keyhole limpet hemocyanin, GM-CSF, regulatory T cells, myeloid-derived suppressor cells, antitumor immunity, vaccine safety, complete response
- MeSH terms
- Adolescent, Adult, Aged, Antigens, Neoplasm, Bone Neoplasms, Feasibility Studies, Female, Hemocyanins, HLA-DR Antigens, Humans, Injections, Intradermal, Lung Neoplasms, Male, Melanoma, Middle Aged, Neoplasm Proteins, Neoplasm Staging, Protamines, Remission Induction, RNA, Messenger, CD4 Antigens, Granulocyte-Macrophage Colony-Stimulating Factor, Immunotherapy, Active, Cancer Vaccines, Myeloid Cells, CD11b Antigen, Cell Proliferation, T-Lymphocytes, Regulatory, Forkhead Transcription Factors, Melanoma-Specific Antigens
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