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Results of the First Phase I/II Clinical Vaccination Trial With Direct Injection of mRNA
Abstract
Vaccination against tumor antigens has been shown to be a safe and efficacious prophylactic and therapeutic antitumor treatment in many animal models. Clinical studies in humans indicate that specific immunotherapy can also result in clinical benefits. The active pharmaceutical ingredient in such vaccines can be DNA, RNA, protein, or peptide and can be administered naked, encapsulated, or after delivery in vitro into cells that are then adoptively transferred. One of the easiest, most versatile and theoretically safest technologies relies on the direct injection of naked messenger RNA (mRNA) that code for tumor antigens. We and others have shown in mice that intradermal application of naked mRNA results in protein expression and the development of an immune response. We used this protocol to vaccinate 15 melanoma patients. For each patient a growing metastasis was removed, total RNA was extracted, reverse-transcribed, amplified, and cloned. Libraries of cDNA were transcribed to produce unlimited amounts of copy mRNA. Autologous preparations were applied intradermally in combination with granulocyte macrophage colony-stimulating factor as adjuvant. We demonstrate here that such treatment is feasible and safe (phase 1 criteria). Furthermore, an increase in antitumor humoral immune response was seen in some patients. However, a demonstration of clinical effectiveness of direct injection of copy mRNA for antitumor immunotherapy was not shown in this study and must be evaluated in subsequent trials.
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“Those studies showed RNA vaccines to be well tolerated and immunogenic.”
From Nonviral delivery of self-amplifying RNA vaccines (2012) · cites this paper as [38]
In the citing paper
“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 [38]
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Self-citationmRNA vaccines: a new era in vaccine development
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“For instance, intradermal injection of naked mRNA encoding TAAs in patients with melanoma under a clinical study, did not show clinical effectiveness [85], though mice intradermally immunised with naked mRNA demonstrated successful protein expression and development of immune response against encoded proteins.”
Steinle, H., Ionescu, T.-M., Schenk, S., Golombek, S., Kunnakattu, S.-J., Oezbek, M. T., Schlensak, C., Wendel, H. P., & Avci‐Adali, M. (2018) · International Journal of Molecular Sciences · doi:10.3390/ijms19051313 · Cited by 36
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mRNA delivery technologies: Toward clinical translation
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“…to express proteins in animals using injections of synthetic mRNAs [5], as well as early reports of vaccination in mice using synthetic mRNA [6,7], to the initial clinical studies started in 2003 for the evaluation of ivt mRNA vaccines in humans [8,9], all used globin UTR-containing mRNAs.”
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“In 1990, Jon Wolff at the University of Wisconsin achieved a groundbreaking breakthrough by demonstrating that the direct injection of mRNA into animals resulted in protein expression [2].”
BackgroundHistoric nucleic acids isolated by Friedrich Miescher contain RNA besides DNA
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BackgroundSelf-citationIntratumoral delivery of mRNA: Overcoming obstacles for effective immunotherapy
der Jeught, K. V., Lint, S. V., Thielemans, K., & Breckpot, K. (2015) · OncoImmunology · doi:10.1080/2162402x.2015.1005504 · Cited by 12
“This implies that the modulation of 1 cell population or suppressive mechanism also impacts others. mRNA: An Interesting Technology Platform for Intratumoral Therapy Weide et al.6 were the first to inject naked tumor mRNA into the dermis of melanoma patients, showing increased humoral immune responses in several patie…”
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“The cross-priming pathway has also been targeted for purposes of prophylactic and therapeutic vaccination (Amigorena, 2000; Palucka et al., 2006; Mitchell et al., 2007; Weide et al., 2008).”
The Dawning of a New Enterprise: RNA Therapeutics for the Skin
Kieser, R. E., Khan, S., Bejar, N., & Kiss, D. (2023) · Journal of Dermatology and Skin Science · doi:10.29245/2767-5092/2023/1.1168 · Cited by 9
“Despite that initial success, nearly two decades passed until data were reported for the first clinical trial employing mRNA as a therapeutic 33 .”
BackgroundTang, S., Liu, G., Yan, Y., Wang, S., & Li, N. (2024) · Analytical Chemistry · doi:10.1021/acs.analchem.4c04384 · Cited by 10
Eslami, S. M., & Lü, X. (2024) · Journal of Controlled Release · doi:10.1016/j.jconrel.2024.10.035 · Cited by 10
The Bright Future of mRNA as a Therapeutic Molecule
Vélez, D. E., Torres, B. L., & Hernández, G. (2025) · Genes · doi:10.3390/genes16040376 · Cited by 11
“The first mRNA vaccine clinical study published was a vaccine against melanoma [110].”
Hoehn, S. J., Krul, S. E., Skory, B. J., & Crespo‐Hernández, C. E. (2021) · Chemistry - A European Journal · doi:10.1002/chem.202103667 · Cited by 9
Emerging trends of research on mRNA vaccines: A co-citation analysis
Chen, J., Zhang, T., Lu, Y. Z., Yang, X., & Ouyang, Z. (2022) · Human Vaccines & Immunotherapeutics · doi:10.1080/21645515.2022.2110409 · Cited by 10
“In 2008, a phase 1/2 trial conducted in 15 melanoma patients shown that direct injection of mRNA couldn’t bring enough clinical effectiveness even though antitumor humoral immune response was stimulated in some patients.(17) In 2009, another phase 1/2 trial conducted in 21 melanoma patients demonstrated the feasibilit…”
BackgroundDevelopment of Gene-Based Vectors for Immunization
Weiner, D. B., & Nabel, G. J. (2017) · Elsevier eBooks · doi:10.1016/b978-0-323-35761-6.00067-5 · Cited by 9
Omokoko, T., Luxemburger, U., Bardissi, S., Simon, P., Utsch, M., Breitkreuz, A., Türeci, Ö., & Şahin, U. (2016) · Journal of Immunology Research · doi:10.1155/2016/9540975 · Cited by 9
“This may be very useful for high-throughput testing in the discovery and selection process of therapeutic mAb candidates as well as the assessment of immune cell and humoral responses in clinical vaccine development [44, 45].”
The past, present, and future of RNA vaccines
Tregoning, J. S., & Sanders, N. N. (2025) · Molecular Therapy · doi:10.1016/j.ymthe.2025.02.016 · Cited by 8
Potential of mRNA vaccines to become versatile cancer vaccines
Tsao, S. Y. (2022) · World Journal of Clinical Oncology · doi:10.5306/wjco.v13.i8.663 · Cited by 8
mRNA—From COVID-19 Treatment to Cancer Immunotherapy
Kŕause, W. (2023) · Biomedicines · doi:10.3390/biomedicines11020308 · Cited by 8
“Naked mRNA Melan-A, MAGE-A1, MAGE-A3, survivin, GP100, and tyrosinase Melanoma Phase I/II + GM-CSF Phase I/II + GM-CSF Intradermal GM-CSF as adjuvant [218] NCT00204516 NCT00204607”
RNA therapeutics – The potential treatment for myocardial infarction
Chu, H., Kohane, D. S., & Langer, R. (2016) · Regenerative Therapy · doi:10.1016/j.reth.2016.03.002 · Cited by 8
“Yet the outcome may be subject to higher patient-to-patient variability due to uncontrollable factors [50].”
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Unleashing the potential of mRNA : Overcoming delivery challenges with nanoparticles
Chen, Q., Huo, K.-G., Ji, S., Pang, S., Sun, T., Niu, Y., Jiang, Z., Zhang, P., Han, S., & Li, J. (2024) · Bioengineering & Translational Medicine · doi:10.1002/btm2.10713 · Cited by 8
“7 In 2017, Cur-eVac for the first time demonstrated a functional anybody boost against the viral antigen by an mRNA vaccine, highlighting the potential of mRNA technology in vaccine development.”
Musa, H. H., & Musa, T. H. (2022) · Human Vaccines & Immunotherapeutics · doi:10.1080/21645515.2022.2135927 · Cited by 11
“Among the top 100 most cited articles, 25% were related to vaccine production and evaluation, 116–118,119-121–123 followed by 23% to safety and efficacy of the vaccine, 124 20% to vaccination, 104–111-125–128 16% to risk factors associated with vaccination,(47,60,62,72,73,75,79,82,95,98,99,101,102,106,109,110,112,114)…”
BackgroundDistinct doorway states lead to triplet excited state generation in epigenetic RNA nucleosides
Wang, D., Wang, X., Jin, P., Zhou, Y., Jia, M., Pan, H., Sun, Z., & Chen, J. (2023) · Physical Chemistry Chemical Physics · doi:10.1039/d3cp00772c · Cited by 7
Accordino, G., Lettieri, S., Bortolotto, C., Benvenuti, S., Gallotti, A., Gattoni, E., Agustoni, F., Pozzi, E., Rinaldi, P., Primiceri, C., et al. (2020) · Cancers · doi:10.3390/cancers12082105 · Cited by 7
“Preclinical [191,192] and clinical studies [193,194] have demonstrated that DCs transfected with stabilized mRNA coding for tumor-associated antigen/whole tumor RNA can generate potent anticancer immune responses.”
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Unlocking cancer vaccine potential: What are the key factors?
Grant, M. D., Lee, L. N., Chinnakannan, S. K., Tong, O., Kwok, J., Cianci, N., Tillman, L., Saha, A., Almeida, V. P., & Leung, C. S. K. (2024) · Human Vaccines & Immunotherapeutics · doi:10.1080/21645515.2024.2331486 · Cited by 6
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“…2020), other researchers started using these advances to target diseases and infections including but not limited to anti-tumor immune responses (Weide et al. 2008), influenza virus A infections in mice (Petsch et al. 2012), Zika virus in mice (Pardi et al. 2017; Richner et al. 2017), and avian…”
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Recent developments in cancer vaccines
Mukherjee, B., Hoque, A. A., Chakraborty, A., Chakraborty, S., Dutta, L., Dutta, D., Banerjee, S., Dhara, M., & Deepa, R. M. (2022) · Elsevier eBooks · doi:10.1016/b978-0-12-823686-4.00018-5 · Cited by 6
RNA Vaccination Therapy: Advances in an Emerging Field
Kreiter, S., Diken, M., Pascolo, S., Nair, S. K., Thielemans, K., & Geall, A. J. (2016) · Journal of Immunology Research · doi:10.1155/2016/9703914 · Cited by 7
“proved that direct injection of naked or protamine-protected RNA intradermally can lead to induction of T cell and antibody responses in preclinical models and then translated the approach into a clinical setting [7–10].”
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Challenges and Opportunities Used in RNA-Based Therapeutics
Chauhan, P., Tiwari, I., & Sharma, N. K. (2025) · Springer eBooks · doi:10.1007/978-981-96-3456-9_10 · Cited by 5
Metadata
- Authors
- Weide, B., Carralot, J.-P., Reese, A., Scheel, B., Eigentler, T. K., Hoerr, I., Rammensee, H.-G., Garbe, C., & Pascolo, S.
- Affiliations
- University of Tübingen (DE)
- CureVac (Germany) (DE)
- Corresponding author
- Weide, Benjamin
- Reese, Anne
- Eigentler, Thomas Kurt
- Garbe, Claus
- Venue
- Journal of Immunotherapy
- Published
- 2008-02
- Volume
- 31
- Issue
- 2
- Pages
- 180-188
- ISSN
- 1524-9557 (ISSN-L)
- OpenAlex
- W2066847748
- Cited by
- 261
- References
- 15
- Citations by year
- 2026: 10 · 2025: 13 · 2024: 17 · 2023: 26 · 2022: 22 · 2021: 30 · 2020: 13 · 2019: 12 · 2018: 8 · 2017: 11 · 2016: 16 · 2015: 13 · 2014: 12 · 2013: 14 · 2012: 13
- FWCI
- 4.16
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Immunotherapy (publishedVersion)
- PubMed (publishedVersion)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion)
- Topics
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › RNA Interference and Gene Delivery
- Keywords
- mRNA vaccination, cancer immunotherapy, melanoma, tumor antigens, intradermal injection, GM-CSF, adjuvants, humoral immune response, feasibility and safety
- MeSH terms
- Adult, Aged, Antibody Formation, Antigens, Neoplasm, Female, Humans, Immunity, Cellular, Injections, Intradermal, Interferon-gamma, Male, Melanoma, Middle Aged, Neoplasm Metastasis, Neoplasm Staging, RNA, Messenger, Monitoring, Immunologic, CD4-Positive T-Lymphocytes, Granulocyte-Macrophage Colony-Stimulating Factor, Treatment Outcome, CD8-Positive T-Lymphocytes, Cancer Vaccines, Cell Line, Tumor
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