Self-adjuvanted mRNA vaccination in advanced prostate cancer patients: a first-in-man phase I/IIa study
Open accessAbstract
BACKGROUND: CV9103 is a prostate-cancer vaccine containing self-adjuvanted mRNA (RNActive®) encoding the antigens PSA, PSCA, PSMA, and STEAP1. This phase I/IIa study evaluated safety and immunogenicity of CV9103 in patients with advanced castration-resistant prostate-cancer. METHODS: 44 Patients received up to 5 intra-dermal vaccinations. Three dose levels of total mRNA were tested in Phase I in cohorts of 3-6 patients to determine a recommended dose. In phase II, 32 additional patients were treated at the recommended dose. The primary endpoint was safety and tolerability, the secondary endpoint was induction of antigen specific immune responses monitored at baseline and at weeks 5, 9 and 17. RESULTS: The most frequent adverse events were grade 1/2 injection site erythema, injection site reactions, fatigue, pyrexia, chills and influenza-like illness. Possibly treatment related urinary retention occurred in 3 patients. The recommended dose was 1280 μg. A total of 26/33 evaluable patients treated at 1280 μg developed an immune response, directed against multiple antigens in 15 out of 33 patients. One patient showed a confirmed PSA response. In the subgroup of 36 metastatic patients, the Kaplan-Meier estimate of median overall survival was 31.4 months [95 % CI: 21.2; n.a]. CONCLUSIONS: The self-adjuvanted RNActive® vaccine CV9103 was well tolerated and immunogenic. The technology is a versatile, fast and cost-effective platform allowing for creation of vaccines. The follow-up vaccine CV9104 including the additional antigens prostatic acid phosphatase (PAP) and Muc1 is currently being tested in a randomized phase IIb trial to assess the clinical benefit induced by this new vaccination approach. TRIAL REGISTRATION: EU Clinical Trials Register: EudraCT number 2008-003967-37, registered 27 Jan 2009.
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Both CVnCoV and CV2CoV are based on RNActive technology and consist of non-chemically modified sequence-engineered mRNA without pseudouridine.
“Both CVnCoV and CV2CoV are based on RNActive technology4–7 and consist of non-chemically modified sequence-engineered mRNA without pseudouridine6–12.”
From Optimization of non-coding regions for a non-modified mRNA COVID-19 vaccine (2022) · cites this paper as [7]
The Background and Methods (RNActive® technology; page not provided) describe RNActive as an mRNA-vaccine platform using free and protamine-complexed mRNA. Our copy studies CV9103, however, and does not identify CVnCoV or CV2CoV or establish that their mRNA is sequence-engineered, non-chemically modified, or free of pseudouridine. (LLM, conf=0.79)
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- Authors
- Kübler, H., Scheel, B., Gnad-Vogt, U., Miller, K., Schultze-Seemann, W., vom Dorp, F., Parmiani, G., Hampel, C., Wedel, S., Trojan, L., Jocham, D., Maurer, T., Rippin, G., Fotin-Mleczek, M., von der Mülbe, F., Probst, J., Hoerr, I., Kallen, K.-J., Lander, T., & Stenzl, A.
- Affiliations
- TUM Klinikum (DE)
- CureVac (Germany) (DE)
- Charité – Universitätsmedizin Berlin (DE)
- IRCCS Ospedale San Raffaele (IT)
- Johannes Gutenberg University Mainz (DE)
- Ortenau Klinikum (DE)
- University Medical Centre Mannheim (DE)
- University Hospital Schleswig-Holstein (DE)
- Universitätsklinikum Tübingen (DE)
- Corresponding author
- Scheel, Birgit
- Venue
- Journal for Immunotherapy of Cancer
- Publisher
- BMJ
- Published
- 2015-06-16
- Volume
- 3
- Issue
- 1
- Pages
- 26-26
- ISSN
- 2051-1426 (ISSN-L)
- PMC
- PMC4468959
- OpenAlex
- W1833523230
- Cited by
- 287
- References
- 51
- Citations by year
- 2026: 13 · 2025: 32 · 2024: 34 · 2023: 45 · 2022: 37 · 2021: 41 · 2020: 15 · 2019: 11 · 2018: 18 · 2017: 19 · 2016: 20 · 2015: 2
- FWCI
- 9.67
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Journal for ImmunoTherapy of Cancer (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- FreiDok plus (Universitätsbibliothek Freiburg) (submittedVersion)
- GoeScholar The Publication Server of the Georg-August-Universität Göttingen (Georg-August-Universität Göttingen) (submittedVersion, cc-by)
- mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion)
- Funders
- European Commission (518234)
- Sixth Framework Programme
- Topics
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Treatment and Research
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Diagnosis and Treatment
- Keywords
- mRNA vaccines, castration-resistant prostate cancer, advanced prostate cancer, vaccine safety, immunogenicity, PSA, prostate stem cell antigen, prostate-specific membrane antigen, STEAP1, antigen-specific immune response, recommended dose, overall survival, metastatic prostate cancer
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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