A Safety and Immunogenicity Study of a Plasmid DNA Prime and MVA Boost Vaccine in HIV-1 (Human Immunodeficiency Virus-1) Infected Adults on ART
GV-TH-01 is an open label Phase 1 study of 9 HIV-1 infected adults with suppressed viremia who started anti-retroviral therapy (ART) within 18 months of a negative HIV antibody test. This study has 3 phases. The first phase is the vaccination phase, where patients are vaccinated with pGA2/JS7 (JS7)DNA and MVA62B vaccines on a prime/boost regimen at weeks 1 and 9 (JS7 DNA vaccine) and weeks 17 and 25 (MVA62B). Both vaccines express Gag, Pol, and Env. The second phase of the study is a treatment interruption phase, whereby ART is interrupted for a 12 week period approximately 8 weeks following the last vaccination. The third phase occurs after the 12 week treatment interruption phase and is called the treatment reinstitution phase, because subjects reinstitute ART and are followed for an additional 24 weeks. The primary objective is to evaluate the safety of the vaccines during the three phases of the study. A secondary objective is to evaluate the immunogenicity of the vaccines during the vaccination phase of the study.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Prime-boost Vaccine Regimen of pGA2/JS7 DNA and MVA/HIV62B in HIV-infected Adults With Suppressed Viremia Who Started ART Within 18 Months of a Negative HIV Antibody Test|
- Safety in all phases of study. [ Time Frame: Throughout study - up to 77 weeks ] [ Designated as safety issue: Yes ]Frequency and severity of adverse events, laboratory abnormalities, and local and systemic reactogenicity signs and symptoms following vaccinations. Vaccination(virologic failure): HIV-1 RNA >200 copies/mL and CD4+ <350 cells/uL; genotypic resistance patterns of re-emergent virus. Treatment interruption:number(#)and percentage(%): 1)meet HIV-1 RNA and CD4+ criteria to re-institute anti-retroviral therapy before 12 wks; 2)genotypic resistance in re-emergent virus. Treatment reinstitution:# and %: 1)meet criteria for virologic failure; 2)genotypic resistance in patients with virologic failure.
- Immunogenicity [ Time Frame: Throughout vaccination and treatment interruption phases ] [ Designated as safety issue: No ]Magnitude of interferon (ifn) gamma &/or interleukin-2 (IL-2) producing CD4+ and CD8+ T cells at 1 week (wk) post 2nd MVA (modified vaccinia ankara) vaccination (vacc); titer & avidity index of binding aby for Env at 2 wks post 2nd MVA vacc. Magnitude of ifn-gamma &/or IL-2 producing CD4+ & CD8+ cells, # and id of Gag-specific CD8+ responses & titers of binding aby for Env at 2 wks post detection of re-emergent virus. Log change in HIV-1 RNA from before antiretroviral therapy to end of treatment interruption; time to HIV-1 rebound to >200 copies/mL.
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: JS7 plasmid DNA and MVA62B vaccines
All subjects receive JS7 plasmid DNA (at 1 and 9 weeks) and MVA62B vaccines (17 and 25 weeks), followed (in 2 months after last vaccination) by a 12-week treatment interruption phase. Subjects reinstitute therapy after the treatment interruption and are followed for 6 months.
Biological: JS7 plasmid DNA and MVA62B vaccine
JS7 plasmid DNA (3 mg at weeks 1 and 9) and MVA62B vaccine (10(8) TCID(50) at weeks 17 and 25)
Other Name: pGA2/JS7 and MVA/HIV62B vaccine
|United States, Alabama|
|The University of Alabama at Birmingham Alabama Vaccine Research Clinic|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|AIDS Research Alliance|
|Los Angeles, California, United States, 90015|
|United States, Georgia|
|AIDS Research Consortium of Atlanta|
|Atlanta, Georgia, United States, 30312|
|Study Chair:||Harriet L Robinson, PhD||GeoVax, Inc.|