Evaluating the Safety and Immune Response of DNA/MVA Vaccines in HIV-1-Infected Young Adults Taking Anti-HIV Medications
|HIV Infections||Biological: GEO-D03 DNA Vaccine Biological: MVA/HIV62B Vaccine Biological: Placebo for DNA GEO-D03 Biological: Placebo for MVA/HIV62B Vaccine||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
|Official Title:||A Phase 1 Study of the Safety and Immunogenicity of DNA/MVA Immunizations With Co-Expressed GM-CSF in HIV-1 Infected Young Adults With Suppressed Viremia on HAART|
- Grade 3 or higher adverse events (AEs) [ Time Frame: Measured through Week 120 ]
- Progression of HIV disease status: immunological decline [ Time Frame: Measured through Week 120 ]Immunological decline defined as a fall in CD4 T-cell count to fewer than 350 cells/mm^3 OR a decline to a level less than 50 percent of baseline, if baseline CD4 T-cell count is more than 700 cells/mm^3 at study entry
- Progression of HIV disease status: RNA 1,000 copies/mL or greater measured on two occasions at least 1 week apart [ Time Frame: Measured through Week 120 ]
- Progression of HIV disease status: development of an AIDS‐defining opportunistic infection or malignancy [ Time Frame: Measured through Week 120 ]
- A greater than or equal to two-fold increase in the frequency of responding HIV-1 Gag-specific CD8 T cells between entry visit and Week 17 visit [ Time Frame: Measured through Week 17 ]
- Grade 3 or higher AEs at least possibly related to study treatment [ Time Frame: Measured through Week 120 ]
- A greater than or equal to two-fold increase in the frequency of responding HIV-1 Gag-specific CD8 T cells per individual between entry visit and Week 25 visit [ Time Frame: Measured through Week 25 ]
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Experimental: Arm A: GEO-D03 DNA and MVA/HIV62B vaccines
At study entry and Week 8, participants will receive the GEO-D03 DNA vaccine administered as 1 mL intramuscularly (IM) in either deltoid. At Weeks 16 and 24, they will receive the MVA/HIV62B vaccine administered as 1 mL IM in either deltoid.
Biological: GEO-D03 DNA Vaccine
DNA GEO-D03 vaccine will be administered as a 3 mg dose IM.Biological: MVA/HIV62B Vaccine
MVA/HIV62B vaccine will be administered as a 1 x 10^8 TCID50 dose IM.
Placebo Comparator: Arm B: Placebo for GEO-D03 and MVA/HIV62B
At study entry and Week 8, participants will receive the placebo for GEO-D03 DNA vaccine administered as 1 mL IM in either deltoid. At Weeks 16 and 24, they will receive the placebo for MVA/HIV62B vaccine administered as 1 mL IM in either deltoid.
Biological: Placebo for DNA GEO-D03
Placebo for DNA GEO-D03 (administered as 0.9 percent Sodium Chloride for Injection) will be administered IM.Biological: Placebo for MVA/HIV62B Vaccine
Placebo for MVA/HIV62B 1 x 10^8 TCID50 (administered as 0.9 percent Sodium Chloride for Injection) will be administered IM.
This study will evaluate the safety and immune response of the combination of two vaccines: a multigene DNA HIV-1 vaccine that also expresses GM-CSF (GEO-D03) and a MVA HIV-1 (MVA/HIV62B) vaccine. HIV-1-infected young adults who have suppressed viral levels, have likely acquired (Clade B) HIV-1 infection from sexual contact, and are on highly active antiretroviral therapy (HAART) will be randomly assigned to one of two study arms. Arm A participants will receive the GEO-D03 vaccine at entry and Week 8 and the MVA/HIV62B vaccine at Weeks 16 and 24. Arm B participants will receive placebo vaccines at entry and at Weeks 8, 16, and 24.
Study duration will be 120 weeks (24 weeks for vaccinations plus 96 weeks of follow-up). Study participants will remain on HAART throughout the study. Study visits will occur at screening, entry, and at Weeks 1, 8, 9, 16, 17, 24, 25, 36, 48, 72, 96, and 120. At each study visit, participants will undergo blood collection, a physical exam, and an adherence assessment. At screening, participants will also undergo an electrocardiogram (ECG) and urine collection. Some blood samples will be stored for future use.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01909414
|Study Chair:||Thomas Greenough, MD||University of MA Medical School (UMMS)-II Biotech|