ong-term follow-up study of immune response to vaccinations with RV001 in patients enrolled in RhoVac-001 study
Phase 1
- Conditions
- Prostate cancerTherapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2020-004705-31-DK
- Lead Sponsor
- RhoVac ApS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 22
Inclusion Criteria
1) Patients who previously participated in RhoVac-001 study.
2) Patients who have provided written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 19
Exclusion Criteria
3) Health conditions which in the opinion of the investigator will preclude the patient from participating in the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine if an long-term immunological response exists to vaccinations given to patients who previously participatied in the RhoVac-001 study ;Secondary Objective: To correlate levels in prostate-specific antigen (PSA) to any long-term immunological response;Primary end point(s): Immunological response;Timepoint(s) of evaluation of this end point: At enrolment.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): PSA level;Timepoint(s) of evaluation of this end point: At enrolment.