TY  - JOUR
AU  - Fresnillo Saló, Sara
AU  - Schuhmacher, Juliane
AU  - Rahbech, Anne
AU  - Pedersen, Sara Ram
AU  - Seremet, Tina
AU  - Matillas, Valero Andreu
AU  - Schöllhorn, Anna
AU  - Røder, Andreas
AU  - Jørgensen, Steffen Wad
AU  - Brasso, Klaus
AU  - Gouttefangeas, Cécile
AU  - Straten, Per Thor
AU  - On Behalf Of The RhoVac-Study Group
TI  - Vaccination Against RhoC in Prostate Cancer Patients Induces Potent and Long-Lasting CD4+ T Cell Responses with Cytolytic Potential in the Absence of Clinical Efficacy: A Randomized Phase II Trial.
JO  - Vaccines
VL  - 13
IS  - 4
SN  - 2076-393X
CY  - Basel
PB  - MDPI
M1  - DKFZ-2025-00938
SP  - 390
PY  - 2025
AB  - Background: A previous phase I/II study demonstrated potent and long-term immune responses in men with prostate cancer following vaccination with a 20mer synthetic peptide (RV001) derived from the Ras homolog gene family member C protein (RhoC). Moreover, a fraction of patients experienced prostate-specific antigen (PSA) responses, which prompted the initiation of a phase II double-blind randomized trial (NCT04114825). The primary endpoint was to study whether vaccination could postpone PSA progression. Furthermore, the study included an evaluation of vaccination-induced immune responses, and in-depth in vitro studies of RhoC-specific CD4+ T cell responses. Methods: Men with non-metastatic biochemical recurrence after either radical prostatectomy or radiation therapy were eligible for the study. Participants were randomized 1:1 to either subcutaneous injections of 0.1 mg/mL RV001 emulsified in Montanide ISA 51, or a placebo. Vaccinations were administered every 2 weeks for the first six times, then five times every 4 weeks for a total treatment time of 30 weeks. Blood samples were collected from a subset of patients (n = 38) over the course of vaccination, and peripheral blood mononuclear cells (PBMCs) isolated for immunological assessment of vaccine-induced immune responses. Experiments using PBMCs from a healthy donor and a patient were performed to study the phenotype and function of RV001-specific CD4+ T cells. Results: A total of 192 men entered the study. There was no difference in time to PSA doubling, with 7.5 versus 9.3 months, or in time to initiating further therapies, 11.2 versus 17.6 months for treatment and control groups, respectively. At long-term follow-up, 12.9
KW  - CD4+ T cells (Other)
KW  - RhoC (Other)
KW  - cancer vaccine (Other)
LB  - PUB:(DE-HGF)16
C6  - pmid:40333248
DO  - DOI:10.3390/vaccines13040390
UR  - https://inrepo02.dkfz.de/record/300824
ER  -