ArticleJournal for immunotherapy of cancer2015
Self-adjuvanted mRNA vaccination in advanced prostate cancer patients: a first-in-man phase I/IIa study.
Article in Journal for immunotherapy of cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 169 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
169 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Comparative efficacy, immune response, and safety of mRNA versus dendritic cell vaccines in solid tumors: a systematic review and meta-analysis.Journal of translational medicine · 2026Pooled it
- A systematic and thematic analysis of the top 100 cited articles on mRNA vaccine indexed in Scopus database.Human vaccines & immunotherapeutics · 2022Pooled it
- Safety and immunogenicity of novel 5T4 viral vectored vaccination regimens in early stage prostate cancer: a phase I clinical trial.Journal for immunotherapy of cancer · 2020Trial
- A phase I/IIa study of the mRNA-based cancer immunotherapy CV9201 in patients with stage IIIB/IV non-small cell lung cancer.Cancer immunology, immunotherapy : CII · 2019Trial
- Novel lipid nanoparticle in a mRNA cancer vaccine drives tumor control via type I IFNs and effector CD8Molecular therapy. Nucleic acids · 2026Article
- Exploring the potential of mRNA vaccines in combatting communicable and non-communicable diseases in low-income and lower-middle-income countries.Annals of medicine and surgery (2012) · 2026Review
- Construction of a Neoantigen Prognostic Model for Gastric Adenocarcinoma Based on Multi-Omics Data Mining and the Design of mRNA Vaccines and Targeted Drugs.International journal of molecular sciences · 2026Article
- Microneedles for Vaccination: Mechanistic Foundations, Materials Innovation, Clinical Translation, and Global Health Implementation.Pharmaceutics · 2026Review
- The landscape of genitourinary cancer vaccines: clinical advances and future opportunities.Journal of advanced research · 2026Review
- Personalized cancer vaccines: bridging immune-oncology and precision medicine for advanced therapeutics.Signal transduction and targeted therapy · 2026Review
- Oncofetal reprogramming in hepatocellular carcinoma: linking developmental programs to cancer vaccines and immunotherapy.Clinical and molecular hepatology · 2026Review
- Comparison of subcellular trafficking of the low molecular weight protamine (LMWP) fragment in tumor and non-tumor cells.Molecular biology reports · 2026Article
- Recent advances and future prospects of immunotherapeutic approaches in prostate cancer.Journal of translational medicine · 2026Review
- The mRNA-Based Innovative Strategy: Progress and Challenges.Nano-micro letters · 2026Review
- Research on the Mechanism of "Cold Tumor" Formation and Immunotherapy for Its Transformation into "Hot Tumor".Oncology research · 2026Review
- The evolution of vaccine strategies for colorectal cancer: from conventional approaches to the mRNA era.Frontiers in immunology · 2026Review
- Cancer Therapy with Polymeric Nanocarriers and the Transition to Targeted Cancer Therapy: Advances and Future Directions.Pharmaceutical nanotechnology · 2026Review
- Nanomedicine Targeting Cancer-Associated Fibroblasts in Prostate Cancer: From Biological Mechanisms to Integrated Theranostic Strategies.International journal of nanomedicine · 2026Review
- mRNA therapeutics: Transforming medicine through innovation in design, delivery, and disease treatment.Molecular therapy. Nucleic acids · 2025Review
- Advances in RNA-based cancer therapeutics: pre-clinical and clinical implications.Molecular cancer · 2025Review
109 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCV9103 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.
methods44 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.
resultsThe 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].
conclusionsThe 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 registrationEU Clinical Trials Register: EudraCT number 2008-003967-37, registered 27 Jan 2009.
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.