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New treatment option for Human Immunodeficiency Virus
Official title HIV Therapeutic DNA Vaccine (ICVAX) Phase I Clinical Trial in Hong Kong
ClinicalTrials.gov ID: NCT07530198
What this study is testing
What is ICVAX (TERESA-EPT I device)?
ICVAX (TERESA-EPT I device) is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for human immunodeficiency virus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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;
You likely can't join if
- 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...
- Has a history of autoimmune diseases; Has hypersensitivity to the components of this drug including ICVAX recombinant plasmid, NaCl, Na2HPO4 and...
- Received approved vaccines within the past 3 months;
See the full eligibility 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.
- 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...
- 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...
- 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 \ 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shatin, New Territories, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shatin, New Territories, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.