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

Prior treatment

• 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;
• 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);
• Have contraindications for intramuscular administration such as confirmed thrombocytopenia, any coagulation dysfunction or currently receiving anticoagulation therapy;

Other illness

• 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;
• 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 medical history or clinical manifestations of any physical or mental illness that may affect the subject's completion of this study;

Lab values

• Has any abnormal laboratory results including: neutrophil \<1×109/L, serum creatinine \> ULN, ALT or AST \>1.5×ULN, hemoglobin \< 11g/dL;

Other

• 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;
• 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;
• The investigator considers that he/she is not suitable to participate in this trial.

• 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.