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| Name | Class |
|---|---|
| Immuno Cure 1 Limited | INDUSTRY |
| The University of Hong Kong | OTHER |
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The goal of this randomized clinical trial is to evaluate the safety and immunogenicity of the HIV Therapeutic DNA Vaccine (ICVAX) in participants with HIV-1 infection under antiretroviral therapy (ART). The study compares three delivery methods - Teresa -EPT I, PharmaJet Tropis, and PapiVax TriGrid EP - to induce antigen-specific T cell responses in the participants.
The primary objectives are to evaluate the safety of ICVAX delivered using three different devices in the participants within the period Day 0-Day 336, and to evaluate the antigen-specific T cell responses induced by ICVAX in the participants within the period Day 0-Day 168.
The participants will receive four injections of ICVAX administered at 4-week intervals. Following the final dose, participants will be monitored for 36 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: ICVAX administration via TERESA-EPT I device | Experimental | Participants with HIV-1 infection under Antiretroviral Therapy (ART) will receive ICVAX at Day 0, Day 28, Day 56 and Day 84. The participants in this arm will receive ICVAX via the TERESA-EPT I device. |
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| Arm 2: ICVAX administration via PharmaJet Tropis device | Experimental | Participants with HIV-1 infection under Antiretroviral Therapy (ART) will receive ICVAX at Day 0, Day 28, Day 56 and Day 84. The participants in this arm will receive ICVAX via the PharmaJet Tropis device. |
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| Arm 3: ICVAX administration via TriGrid device | Experimental | Participants with HIV-1 infection under Antiretroviral Therapy (ART) will receive ICVAX at Day 0, Day 28, Day 56 and Day 84. The participants in this arm will receive ICVAX via the TriGrid device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICVAX (TERESA-EPT I device) | Biological | ICVAX is a HIV therapeutic DNA drug developed by Immuno Cure Group based on the PD-1-Enhanced DNA Vaccine Technology platform. ICVAX will be administered intramuscularly followed by electroporation using the TERESA-EPT I device. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of ICVAX | To evaluate the incidence of adverse events and abnormal laboratory results within the period Day 0-Day 336. | Day 0-Day 336 |
| Antigen-specific T Cell Response Induced by ICVAX | To evaluate the antigen-specific T cell responses induced by ICVAX within the period Day 0-Day 168 via ELISpot. | Day 0-Day 168 |
| Measure | Description | Time Frame |
|---|---|---|
| Humoral Immune Response of ICVAX | To evaluate humoral immune response of ICVAX within the period Day 0-Day 336 via ELISA. | Day 0-Day 336 |
| Effect of ICVAX-ART Combined Treatment on Viral Reservoir |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grace Chung Yan Lui, Dr. | Contact | (852) 5569 9539 | gracelui@cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Grace Chung Yan Lui, Dr. | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chinese University of Hong Kong Phase 1 Clinical Trial Centre at Prince of Wales Hospital | Recruiting | Shatin | New Territories | 00000 | Hong Kong |
The results of this study will be publicly disseminated by ways of publication(s) in peer-reviewed scientific journal(s), presentation(s) in scientific conference(s), posting on public clinical trial registry(ies) and/or otherwise instead of individual participant data (IPD) sharing.
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ICVAX (PharmaJet Tropis device) | Biological | ICVAX will be administered intradermally using the PharmaJet Tropis device. |
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| ICVAX (TriGrid device) | Biological | ICVAX will be administered intramuscularly followed by electroporation using the TriGrid device. |
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To evaluate the effect of ICVAX-ART combined treatment on the viral reservoir within the period Day 0-Day 336 via PCR.
| Day 0-Day 336 |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |