Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03606213 | Therapeutic Vaccination in Treated HIV Disease | PHASE1 | COMPLETED | 56 | — | — | Aug 1, 2018 | May 17, 2021 | May 31, 2023 | 2 | United States |
Counts and percentages of adverse events will be presented in frequency tables and characterized for each arm with 95% Clopper-Pearson Confidence Intervals. We will use the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1
The magnitude of Gag-specific responses was characterized in detail via matrix mapping using vaccine-matched peptides, while pools of 15 overlapping peptides will used to evaluate the magnitude of T cell response to Pol and Env, as well as Nef (internal control). In addition, ELISpot responses to pools of Gag, Pol, Env, and Nef peptides (n=50 peptides/pool) that have been derived from circulating HIV viruses (potential T cell epitope peptides, PTE; NIH AIDS Reagent Program) were evaluated in parallel. All measures were performed on two baseline PBMC samples. The primary outcome in terms of the magnitude of the response was calculated as the fold-change (ratio) in the number of spot-forming units per million peripheral blood mononuclear cells between week 14 and baseline (pre-vaccine).
| Arm | Type | Description |
|---|---|---|
| Cohort A - Arm 1 | PLACEBO_COMPARATOR | Placebo will be administered by electoporation at Day 0 and Weeks 4, 8 and 12 |
| Cohort A - Arm 2 | ACTIVE_COMPARATOR | Active gag/pol, env and IL-12 plasmids (PENNVAX-GP and INO-9102)) administered by electoporation (CELLECTRA-2000) at Day 0 and Weeks 4, 8 and 12. |
| Cohort A - Arm 3 | ACTIVE_COMPARATOR | Active gag/pol and IL-12 plasmids (INO-6145 INO-9012) will be administered by electroporation (CELLECTRA-2000) at Day 0 and Weeks 4, 8 and 12. |
| Cohort B - Arm 1 | ACTIVE_COMPARATOR | A single arm study of gag/pol/env/IL-12 DNA plasmids PENNVAX-GP and INO-9102) administered by electoporation (CELLECTRA-2000) will be performed in HIV-infected adults for whom ART was initiated during acute HIV infection. |
| Name | Type | Description |
|---|---|---|
| PENNVAX-GP | BIOLOGICAL | PENNVAX®-GP is a circular, double stranded, deoxyribonucleic acid consisting of expression plasmids that encode synthetic HIV-1 multiclade consensus Gag, Pol and Env proteins. |
| INO-6145 | BIOLOGICAL | INO-6145 is a circular, double stranded, deoxyribonucleic acid consisting of expression plasmids that encode synthetic HIV-1 multiclade consensus Gag and Pol proteins. |
| INO-9012 | BIOLOGICAL | The IL-12 DNA adjuvant (INO-9012) consists of a single plasmid containing a dual promoter system for expression of both the IL-12 p35 and p40 genes necessary for production of the active heterodimeric (p70) IL-12 protein. |
| CELLECTRA® 2000 | DEVICE | Electroporation (EP) is a technology in which an electrical field is applied to increase the permeability of cell membranes and thereby enhance the uptake of drugs, vaccines, or other agents into target cells. This technology has been used in the last decade in both therapeutics and vaccinations. EP is currently being used to deliver cancer vaccines and therapeutics as well as in gene therapy. The expression levels are increased by as much as 3 orders of magnitude over plasmid injection alone. |
Inclusion Criteria: 1. Willing and able to provide written informed consent 2. Male or female, age ≥ 18 and ≤ 65 years 3. HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a li...