PIPELINE
PBS Clinical Trials

With support provided by multiple collaborating and funding agencies, Profectus has conducted a series of clinical trials to systematically validate the components of the PBS Vax™ platform. These trials have been conducted at 30 clinical trials sites located in the U.S. and Africa.

Conducted by the HIV Vaccine Trials Network (HVTN), trial 080 (ClinicalTrials.gov identifier NCT00991354; N=48) examined the safety and immunogenicity of three doses of an NIH manufactured multi-antigen HIV pDNA vaccine (gag, pol, env) delivered on days 0, 28, and 84 via electroporation (EP) with and without 1 mg GeneVax IL-12® in HIV-uninfected healthy adults. The primary endpoints included safety and immunogenicity measured by intra-cellular cytokine staining (ICS) of vaccine responsive CD4 and CD8 T cells in cryopreserved peripheral blood mononuclear cells (PBMC). Secondary endpoints included measuring immunogenicity in the interferon-gamma (IFN-γ) enzyme-linked immuno-spot (ELISpot) assay of vaccine responsive total T cells in cryopreserved PBMC.
 
Status: Completed
 
Clinical Results:
GeneVax IL-12® delivered via EP:
  • Safe and well tolerated
  • Increased vaccine-specific CD4 ICS response rate from 44% to 81%
  • Increased gag-specific CD4 ICS response rate from 33% to 65%
  • Increased vaccine-specific CD8 ICS response rate from 33% to 52%
  • Increased gag-specific CD8 ICS response rate from 0% to 7%
Program Milestones:
  • Clinical validation of GeneVax IL-12® adjuvant activity
  • Highest overall T cell ICS response rate observed for any stand alone or prime boost vaccine tested by the HVTN prior to HVTN trial 087 (below)
Conducted in collaboration with the International AIDS Vaccine Initiative (IAVI) and Ichor Medical Systems, the B004 trial (ClinicalTrials.gov identifier NCT01496989; N=75) examined the safety and immunogenicity of the Profectus multi-antigen HIV GeneVax™ vaccine (env, gag, pol, nef, tat, vif) formulated with various dose levels of GeneVax® IL-12 delivered on days 0, 28, 56 with electroporation, followed by Ad35 GRIN/ENV (gag, rt, int, nef, env) vaccine delivered on day 168 in HIV-uninfected healthy adults. The primary endpoints included safety and immunogenicity measured by the IFN-γ ELISpot assay of vaccine responsive total T cells in cryopreserved PBMC. Secondary endpoints included measuring vaccine-specific responses in the CD4 and CD8 T cell subsets by ICS.

Status: Completed

Interim Clinical Results:
GeneVax® with electroporation prime/Ad35 GRIN/ENV boost via IM injection:
  • Safe and well tolerated at all dose levels
  • Vaccine-specific IFN-γ ELISpot total T cell response rate of 94%
  • Vaccine-specific binding Ab response rate of 89%
  • Assays of CD4 and CD8 subset responses by ICS pending
Program Milestones:
  • African trial participants preferred vaccine delivered with the Ichor electroporation device to standard needle and syringe injection
  • Multi-antigen HIV GeneVax™ vaccine plus GeneVax® IL-12 primes for a synergistic INF-γ ELISpot total T cell response to subsequent Ad35 GRIN/ENV boosting
Conducted by the HIV Vaccine Trials Network (HVTN), trial 090 (ClinicalTrials.gov identifier NCT01438606; N=60) examined the safety and immunogenicity of ascending dose levels (104, 105, 106, 107, and 108 plaque-forming units) of a VesiculoVax™ vectored HIV gag vaccine delivered on days 0 and 56 by intramuscular injection to HIV-uninfected healthy adults. The primary endpoints included safety and immunogenicity measured by ICS of vaccine responsive CD4 and CD8 T cells in cryopreserved PBMC. Secondary endpoints included measuring immunogenicity in the IFN-γ ELISpot assay of vaccine responsive total T cells in cryopreserved PBMC.

Status: Completed

Clinical Results:
VesiculoVax™ HIV gag vaccine delivered via IM injection:
  • Safe and well tolerated at all dose levels
  • Vaccine take in 100% of recipients at all dose levels
  • Gag-specific CD4 ICS response rate of 38% at 108 PFU dose level
  • Gag-specific CD8 ICS response rate of 0% at 108 PFU dose level
  • Vaccine-specific IFN-γ ELISpot total T cell response rate of 63%
Program Milestones:
  • First-in-Man clinical validation of safety and immunogenicity of the VesiculoVax™ vectored HIV gag vaccine
Conducted by the AIDS Clinical Trials Group (ACTG), trial 5281 (ClinicalTrials.gov identifier NCT01266616; N=60) is examining the safety and immunogenicity of multi-antigen HIV GeneVax™ vaccine (env, gag, pol, nef, tat, vif) formulated with various dose levels of GeneVax® IL-12 delivered on days 0, 28, 84 with electroporation in HIV infected subjects. The primary endpoints included safety and immunogenicity measured by ICS of vaccine responsive CD4 and CD8 T cells in cryopreserved PBMC.

Status: Enrollment complete

Interim Clinical Results:
GeneVax® HIV Vaccine with GeneVax® IL-12 molecular adjuvant:
  • Safe and well tolerated at all dose levels
  • Assays of CD4 and CD8 subset responses by ICS pending
Program Milestones:
  • Multi-antigen GeneVax® HIV Vaccine plus GeneVax® IL-12 molecular adjuvant delivered by electroporation safe and well tolerated in HIV-infected subjects.
Conducted by the HIV Vaccine Trials Network (HVTN), trial 087 (ClinicalTrials.gov identifier NCT01578889; N=100) is examining the safety and immunogenicity of a PBS Vax™ HIV vaccine. Groups of HIV-uninfected healthy adults are being primed with three doses of a multi-antigen HIV GeneVax™ vaccine (env, gag, pol, nef, tat, vif) formulated with various dose levels of GeneVax® IL-12 delivered on days 0, 28, 84 with electroporation, followed by boosting with VesiculoVax™ vectored HIV gag vaccine delivered on day 168. The primary endpoints included safety and immunogenicity measured by ICS of vaccine responsive CD4 and CD8 T cells in cryopreserved PBMC.

Status: Enrollment complete

Interim Clinical Results:
PBS Vax™ HIV vaccine: GeneVax® with electroporation prime/VesiculoVax™ boost via IM injection:
  • Safe and well tolerated at all dose levels
  • Vaccine-specific CD4 ICS response rate of 92%
  • Gag-specific CD4 ICS response rate of 83% (GeneVax®/VesiculoVax™ synergy)
  • Total vaccine-specific CD8 ICS response rate of 58%
  • Gag-specific CD8 ICS response rate of 26% (GeneVax®/VesiculoVax™ synergy)
Program Milestones:
  • First-in-Man clinical validation of safety and immunogenicity of the PBS Vax™ HIV Vaccine
  • Highest T cell response rate observed for any stand alone or prime boost vaccine tested by the HVTN
Conducted by the NIH Division of AIDS, the TheraVax trial (ClinicalTrials.gov identifier NCT01859325; N=30) is examining the safety and immunogenicity of a PBS Vax™ HIV vaccine. Groups of HIV-infected adults on stable combined anti-retroviral therapy (cART) are being immunized with multi-antigen HIV GeneVax™ vaccine (env, gag, pol, nef, tat, vif) formulated with GeneVax® IL-12 delivered on days 0, 28, 84, 252 with electroporation, and with VesiculoVax™ vectored HIV gag vaccine delivered on days 168 and 336. The primary endpoints include safety and immunogenicity measured by ICS of vaccine responsive CD4 and CD8 T cells in cryopreserved PBMC.

Status: Enrollment ongoing

Interim Clinical Results:
PBS Vax™ HIV vaccine: GeneVax® with electroporation prime/VesiculoVax™ boost via IM injection:
  • 20 of 30 subjects enrolled
  • No safety issues reported
© 2017 Profectus BioSciences, Inc. All Rights Reserved.  |  User Login