A Safety Trial of MVA-BN®-PRO in Men With Androgen-Insensitive Prostate Cancer (BNIT-PR-001)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Phase I Dose Escalation Trial of MVA-BN®-PRO in Men With Androgen-Insensitive Prostate Cancer|
- To evaluate the safety and tolerability of single and multiple injection regimens of MVA-BN®-PRO for the treatment of androgen-insensitive prostate cancer. [ Time Frame: Continuous ] [ Designated as safety issue: No ]
- To evaluate the ability of MVA-BN®-PRO to generate humoral and cellular immune responses to prostate antigens, and to define an optimal dose for future studies. [ Time Frame: Continuous ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Study Completion Date:||September 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Lowest dose level
1x10e8 TCID50 q 4 wks x 6
Middle level dose
2 x 10e8 TCID50 q 4 wks x 6
Highest dose level
4 x 10e8 TCID50 q 4 wks x 6
MVA-BN®-PRO is a candidate prostate cancer immunotherapy product comprised of a highly attenuated non-replicating vaccinia virus, MVA-BN®, engineered to encode prostate specific antigen (PSA) and prostate acid phosphatase (PAP) proteins. The MVA-BN®-based vaccine provides innate and adaptive immune activating factors, and vaccination by this strategy will be evaluated for its capacity to help override self and tumor tolerance mechanisms.
Previous work has shown PSA and PAP antigens to be immunogenic in humans when presented with immune stimulatory components. Multiple clinical studies have demonstrated promising activity of PSA-targeted vaccinia-based immunotherapy. Additionally, PAP-based cellular therapy immunization approaches, have shown promise in Phase III clinical trials and provided for enhanced survival. The strategy undertaken by BNIT is to combine both antigens in the MVA-BN® vector to enhance the immunogenic effect and to help mitigate development of tumor resistance.
This trial examines three vaccination regimens of MVA-BN®-PRO:
Vaccine is provided at (0.5cc/dose/1x10e8 TCID50)
- Cohort 1: 1 sc injection every 4 weeks x 3; retreated once at the same dose and schedule.
- Cohort 2: 2 sc injections every 4 weeks x 3; retreated once at the same dose and schedule.
- Cohort 3: 4 sc injections every 4 weeks x 3; retreated once at the same dose and schedule.
These dose regimens are based on the current dose of MVA-BN® (1x10e8 TCID50 by sc injection) under development as a prophylactic vaccine for the prevention of smallpox, and on related clinical studies of MVA-nef-based vaccines (5x10e8 TCID50) for induction of heterologous immunity.
|United States, Alabama|
|Urology Centers of Alabama|
|Homewood, Alabama, United States, 35209|
|United States, District of Columbia|
|Walter Reed Army Medical Center|
|Washington, District of Columbia, United States, 20307|
|United States, New Jersey|
|Lawrenceville, New Jersey, United States, 08648|
|United States, North Carolina|
|Presbyterian Hospital Center for Cancer Research|
|Charlotte, North Carolina, United States, 28173|
|United States, Tennessee|
|Nashville, Tennessee, United States|
|United States, Texas|
|Urology Clinics of North Texas, PA|
|Dallas, Texas, United States, 75231|
|Urology Associates of South Texas|
|McAllen, Texas, United States, 78503|
|Study Director:||Olga Bandman||Bavarian Nordic, Inc.|