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Virus Therapy

1 for Prostate Cancer (BNIT-PR-001 Trial)

Phase 1
Waitlist Available
Research Sponsored by Bavarian Nordic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

BNIT-PR-001 is an open-label, multi-center, Phase I dosing evaluation trial of MVA-BN®-PRO in men with androgen-insensitive prostate cancer. Patients will have PSA recurrence after being treated with androgen suppression therapy or complete androgen blockade. The trial will consist of a treatment with up to 6 vaccinations with MVA-BN®-PRO at monthly intervals, followed by a 1-year follow-up phase. A vaccination may be 1, 2, or 4 injections of study vaccine. The study is designed to examine safety as well as the effect of three different doses on immune response.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2014 Phase 3 trial • 4005 Patients • NCT01144637
3%
Upper respiratory tract infection
1%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 4
Group 3
Group 2
Group 1

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: 3Experimental Treatment1 Intervention
Highest dose level
Group II: 2Experimental Treatment1 Intervention
Middle level dose
Group III: 1Experimental Treatment1 Intervention
Lowest dose level
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Modified vaccinia ankara
FDA approved

Find a Location

Who is running the clinical trial?

Bavarian NordicLead Sponsor
62 Previous Clinical Trials
50,364 Total Patients Enrolled
1 Trials studying Prostate Cancer
120 Patients Enrolled for Prostate Cancer
Olga BandmanStudy DirectorBavarian Nordic
3 Previous Clinical Trials
165 Total Patients Enrolled
~1 spots leftby Oct 2025
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