HIV Therapeutic DNA Vaccine (ICVAX) Phase I Clinical Trial in Hong Kong

Официальное название

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

Обзор

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.

Вмешательства

• Биопрепарат 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.
• Биопрепарат ICVAX (PharmaJet Tropis device)
  ICVAX will be administered intradermally using the PharmaJet Tropis device.
• Биопрепарат ICVAX (TriGrid device)
  ICVAX will be administered intramuscularly followed by electroporation using the TriGrid device.

Первичные конечные точки

• Safety of ICVAX [Срок оценки: Day 0-Day 336]
• Antigen-specific T Cell Response Induced by ICVAX [Срок оценки: Day 0-Day 168]

Вторичные конечные точки (2)

• Humoral Immune Response of ICVAX [Срок оценки: Day 0-Day 336]
• Effect of ICVAX-ART Combined Treatment on Viral Reservoir [Срок оценки: Day 0-Day 336]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• The Chinese University of Hong Kong Phase 1 Clinical Trial Centre at Prince of Wales Hospi — Shatin

Идентификаторы

NCT: NCT07530198 · ICVAX_HK202401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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