A Safety Trial of MVA-BN®-PRO in Men With Androgen-Insensitive Prostate Cancer
Condition: Androgen-insensitive Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      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.
    

Intervention name(s): MVA-BN-PRO; MVA-BN-PRO; MVA-BN-PRO
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 1x10e8 TCID50 q 4 wks x 6; 2 x 10e8 TCID50 q 4 wks x 6; 4 x 10e8 TCID50 q 4 wks x 6
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: androgen-insensitive, non-metastatic, prostate, cancer