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| Name | Class |
|---|---|
| Auro Vaccines LLC | INDUSTRY |
| Ichor Medical Systems Incorporated | INDUSTRY |
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The purpose of this study is to evaluate the safety, tolerability and immunogenicity of multiantigen HIV (HIV-MAG) plasmid DNA (pDNA) vaccine co-administered with recombinant human IL-12 pDNA (GENEVAX® IL-12) followed or preceded by recombinant Ad35-GRIN/ENV HIV vaccine in low-risk for HIV-uninfected healthy adults.
The study is a randomized, double-blind placebo-controlled trial assessing the safety and tolerability of HIV-MAG with or without co-administered GENEVAX® IL-12 given intramuscularly by in vivo electroporation (IM/EP) using the Ichor Medical Systems TriGrid Delivery System (TDS-IM) followed by Ad35-GRIN/ENV in each of four different regimens. An additional group will evaluate the safety and tolerability of Ad35-GRIN/ENV followed by HIV-MAG with co-administered GENEVAX® IL-12 given intramuscularly by in vivo electroporation (IM/EP) using the Ichor Medical Systems TriGrid Delivery System (TDS-IM).
Volunteers will be screened up to 42 days before the 1st vaccination and will be followed for 12 months after the first vaccine administration. It is anticipated that it will take approximately 3 months to enrol the study. Approximately 75 volunteers (60 vaccine/15 placebo recipients) will be included in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: HIV-MAG followed by Ad35-GRIN/ENV | Experimental | HIV-MAG (IM/EP) at Months 0,1,2 followed by Ad35-GRIN/ENV (IM) at Month 6. (Vaccine:Placebo = 12/3) |
|
| Group 2: HIV-MAG+GENEVAX® IL-12 followed by Ad35-GRIN/ENV | Experimental | HIV-MAG + GENEVAX® IL-12 (IM/EP) at Months 0,1,2 followed by Ad35-GRIN/ENV (IM) at Month 6. (Vaccine:Placebo=12/3) |
|
| Group 3: HIV-MAG+GENEVAX® IL-12 followed by Ad35-GRIN/ENV | Experimental | HIV-MAG + GENEVAX® IL-12 (IM/EP) at Months 0,1,2 followed by Ad35-GRIN/ENV (IM) at Month 6. (Vaccine:Placebo= 12/3) |
|
| Group 4: HIV-MAG+GENEVAX® IL-12 followed by Ad35-GRIN/ENV | Experimental | HIV-MAG + GENEVAX® IL-12 (IM/EP) at Month 0 followed by Ad35-GRIN/ENV (IM) at Month 4. (Vaccine:Placebo=12/3) |
|
| Group 5: Ad35-GRIN/ENV followed by HIV-MAG+GENEVAX® IL-12 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIV-MAG (3,000mcg) | Biological | Delivered intramuscularly by in vivo electroporation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability | To evaluate the safety and tolerability of HIV-MAG, GENEVAX® IL-12, and Ad35-GRIN/ENV administered in five heterologous prime-boost regimens. | 13 months approximately |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | To assess (qualitative and quantitative) immune responses elicited by the different prime-boost regimens. | 12 months |
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Inclusion Criteria:
Principal exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kenya AIDS Vaccine Initiative, Kangemi | Nairobi | Kenya | ||||
| Projet San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32469893 | Derived | Mpendo J, Mutua G, Nanvubya A, Anzala O, Nyombayire J, Karita E, Dally L, Hannaman D, Price M, Fast PE, Priddy F, Gelderblom HC, Hills NK. Acceptability and tolerability of repeated intramuscular electroporation of Multi-antigenic HIV (HIVMAG) DNA vaccine among healthy African participants in a phase 1 randomized controlled trial. PLoS One. 2020 May 29;15(5):e0233151. doi: 10.1371/journal.pone.0233151. eCollection 2020. | |
| 26252526 |
| Label | URL |
|---|---|
| International AIDS Vaccine Initiative | View source |
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Ad35-GRIN/ENV (IM) at Month 0 followed by HIV-MAG + GENEVAX® IL-12 (IM/EP) at Month 4. (Vaccine:Placebo=12/3) |
|
| GENEVAX® IL-12 (100mcg) | Biological | Co-administered with HIV-MAG, delivered intramuscularly by in vivo electroporation |
|
| GENEVAX® IL-12 (1000mcg) | Biological | Co-administered with HIV-MAG, delivered intramuscular by in vivo electroporation |
|
| Ad35-GRIN/ENV | Biological | (2x10^10vp) Delivered intramuscularly by standard needle injection |
|
| Kigali |
| Rwanda |
| Uganda Virus Research Institute-IAVI | Entebbe | Uganda |
| Derived |
| Mpendo J, Mutua G, Nyombayire J, Ingabire R, Nanvubya A, Anzala O, Karita E, Hayes P, Kopycinski J, Dally L, Hannaman D, Egan MA, Eldridge JH, Syvertsen K, Lehrman J, Rasmussen B, Gilmour J, Cox JH, Fast PE, Schmidt C. A Phase I Double Blind, Placebo-Controlled, Randomized Study of the Safety and Immunogenicity of Electroporated HIV DNA with or without Interleukin 12 in Prime-Boost Combinations with an Ad35 HIV Vaccine in Healthy HIV-Seronegative African Adults. PLoS One. 2015 Aug 7;10(8):e0134287. doi: 10.1371/journal.pone.0134287. eCollection 2015. |
| Ichor Medical Systems, Inc. | View source |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
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