HIV Therapeutic DNA Vaccine (ICVAX) Phase I Clinical Trial in Hong Kong
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ICVAX (TERESA-EPT I device), ICVAX (PharmaJet Tropis device), ICVAX (TriGrid device).
- Who it may be relevant to
- Registry conditions: Human Immunodeficiency Virus, Human Immunodeficiency Virus I Infection. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
HIV Therapeutic DNA Vaccine (ICVAX) Phase I Clinical Trial in Hong Kong: Evaluation of Immunogenicity and Safety of ICVAX in ART-treated Clinically Stable HIV-infected Patients
Overview
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.
Interventions
- Biological ICVAX (TERESA-EPT I device)
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. - Biological ICVAX (PharmaJet Tropis device)
ICVAX will be administered intradermally using the PharmaJet Tropis device. - Biological ICVAX (TriGrid device)
ICVAX will be administered intramuscularly followed by electroporation using the TriGrid device.
Primary outcome measures
- Safety of ICVAX [Time frame: Day 0-Day 336]
- Antigen-specific T Cell Response Induced by ICVAX [Time frame: Day 0-Day 168]
Secondary outcome measures (2)
- Humoral Immune Response of ICVAX [Time frame: Day 0-Day 336]
- Effect of ICVAX-ART Combined Treatment on Viral Reservoir [Time frame: Day 0-Day 336]
Eligibility criteria
Inclusion criteria
- Tested positive for HIV-1 antibody;
- Aged 18-60, both male and female;
- BMI (body mass index) in between 18.5 and 24.9 kg/m2 (including upper and lower limits);
- Received ART for ≥12 months; no drug resistance occurred during this treatment period;
- Had <50 copies/ml of plasma HIV RNA for at least (≥) 12 months prior to screening visit;
- Had ≥350 cells/μL of CD4+ T cells in the past 6 months and >200 cells/μL of CD4+ T cells before initiation of ART;
- Adopted contraception method approved by the investigator from screening period until the end of study;
- Understand the study and voluntarily sign the ICF.
Exclusion criteria
- Women who are pregnant or breastfeeding or those who plan to give birth in coming two years (including the subject and his/her spouse);
- ART has been suspended for more than 2 weeks continuously since ART initiation;
- Participated in other clinical trials within 24 weeks before the screening visit;
- Has any opportunistic infections or opportunistic tumors that require systemic treatment within 30 days before being recruited; Has any medical events that the investigator believes will affect the safety and immunogenicity evaluation of the drug;
- Has a history of autoimmune diseases; Has hypersensitivity to the components of this drug including ICVAX recombinant plasmid, NaCl, Na2HPO4 and NaH2PO4·H2O, and shows severe allergies, such as dyspnea, edema and other symptoms after administration;
- Received approved vaccines within the past 3 months;
- Received any blood products, immunoglobulin products, or immunosuppressants within 12 weeks before being recruited;
- Used interferon, systemic corticosteroids, or other immunosuppressants within the last 3 months (except local application);
- Positive Hepatitis B surface antigen (HBsAg) within 12 months, or positive Hepatitis C virus antibody (HCV Ab) at screening with confirmatory HCV RNA positive;
- Has any abnormal laboratory results including: neutrophil <1×109/L, serum creatinine > ULN, ALT or AST >1.5×ULN, hemoglobin < 11g/dL;
- Has any medical history or clinical manifestations of any physical or mental illness that may affect the subject's completion of this study;
- Sensitive to electrical pulse stimulation, such as those who are implanted with pacemaker/ Automatic Implantable Cardioverter Defibrillator (AICD), or those who have wearable medical electronic devices including electrocardiogram;
- Needle phobia;
- Have contraindications for intramuscular administration such as confirmed thrombocytopenia, any coagulation dysfunction or currently receiving anticoagulation therapy;
- The investigator considers that he/she is not suitable to participate in this trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- The Chinese University of Hong Kong Phase 1 Clinical Trial Centre at Prince of Wales Hospi — Shatin
Identifiers
NCT: NCT07530198 · ICVAX_HK202401