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Genital Diseases, Male

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Vaccines

Duration: Patients in Arm A will receive a total of 4 vaccinations with CV9104 in weeks 1, 2, 3 and 5. These patients will undergo radical prostatectomy at least 1 week but not later than 2 weeks after the 4th vaccination (week 6 or 7). After surgery high risk or very high risk patients will be offered to receive 2 additional vaccinations with CV9104 at week 8 and 10 post surgery.

Administration: At each vaccination visit each of the 6 components of CV9104 vaccine will be injected individually, divided in two separate intradermal injections. These 12 Injections will be distributed over the 4 limbs (3 injections in each upper arm and thigh).

Administration site: Skin of the lateral parts of the upper arms (over the deltoid regions) and the lateral part of the thighs.

Dose: 2 x 80 μg mRNA per injection (2 x 100 μL), equals 160 μg mRNA per RNActive® drug product component

Duration: Patients in Arm B will receive a total of 4 vaccinations with CV9104 in weeks 1, 2, 3 and 5. These patients will undergo radical prostatectomy at least 1 week but not later than 2 weeks after the 4th vaccination (week 6 or 7). After surgery high risk or very high risk patients will be offered to receive 2 additional vaccinations with CV9104 at week 8 and 10 post surgery.

Administration: At each vaccination visit each of the 6 components of CV9104 vaccine will be injected individually, divided in two separate intradermal injections. These 12 Injections will be distributed over the 4 limbs (3 injections in each upper arm and thigh).

Administration site: Skin of the medial part of the upper arms and thigh

Dose: 2 x 160 μg mRNA per injection (2 x 200 μL), equals 320 μg mRNA per RNActive® drug product component

Duration: Patients in Arm C will receive no vaccination before radical prostatectomy. After surgery high risk or very high risk patients will be offered to receive 6 vaccinations with CV9104 at week 8, 9, 10, 12, 14 and 16 after surgery.

Administration: At each vaccination visit each of the 6 components of CV9104 vaccine will be injected individually, divided in two separate intradermal injections. These 12 Injections will be distributed over the 4 limbs (3 injections in each upper arm and thigh).

Administration site: Skin of the lateral parts of the upper arms (over the deltoid regions) and the lateral part of the thighs.

Dose: 2 x 80 μg mRNA per injection (2 x 100 μL), equals 160 μg mRNA per RNActive® drug product component

CV9104

needle free injection device (Tropis®)

Arnulf Stenzl, Prof. Dr. med.

The purpose of this study is to evaluate the induction of immune responses against CV9104 administered by conventional intradermal injection or with a needle-free intradermal injection device and to assess the safety and tolerability of CV9104 administered by conventional intradermal injection versus injection with a needle-free intradermal injection device versus no injection.

This study is the second clinical trial of the RNActive® vaccine. It is composed of 6 RNActive® drug product components, coding for 6 antigens that are overexpressed in PCA compared to healthy tissue. Each of the 6 prostate specific antigens that are encoded by CV9104 are capable of inducing adaptive immunity.

Needle-free injection systems, like the Tropis® device for i.d. injection, overcome the disadvantages related to needle- and syringe-based i.d. injections. Tropis® is currently used in different vaccine clinical trials around the world. The use of Tropis® for i.d. delivery of CV9104 has been approved by BfArM.

An Open Label Randomised Trial of RNActive® Cancer Vaccine in High Risk and Intermediate Risk Patients With Prostate Cancer

An Open Label Randomised Phase II Trial of RNActive® Cancer Vaccine (CV9104) in High Risk and Intermediate Risk Patients With Prostate Cancer

CureVac

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Open Label Randomised Trial of RNActive® Cancer Vaccine in High Risk and Intermediate Risk Patients With Prostate Cancer	NCT02140138	Prostate Carcin...	CV9104 needle free inj...	18 Years -	CureVac
An Open Label Randomised Trial of RNActive® Cancer Vaccine in High Risk and Intermediate Risk Patients With Prostate Cancer	NCT02140138	Prostate Carcin...	CV9104 needle free inj...	18 Years -	CureVac
An Open Label Randomised Trial of RNActive® Cancer Vaccine in High Risk and Intermediate Risk Patients With Prostate Cancer	NCT02140138	Prostate Carcin...	CV9104 needle free inj...	18 Years -	CureVac

Spots Global Cancer Trial Database for needle free injection device (tropis®)