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

Exclusion Criteria

• •1. Women who are pregnant or breastfeeding or those who plan to give birth in coming two years (including the subject and his/her spouse);
• •2. ART has been suspended for more than 2 weeks continuously since ART initiation;
• •3. Participated in other clinical trials within 24 weeks before the screening visit;
• •4. 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;
• •5. 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;
• •6. Received approved vaccines within the past 3 months;
• •7. Received any blood products, immunoglobulin products, or immunosuppressants within 12 weeks before being recruited;
• •8. Used interferon, systemic corticosteroids, or other immunosuppressants within the last 3 months (except local application);
• •9. Positive Hepatitis B surface antigen (HBsAg) within 12 months, or positive Hepatitis C virus antibody (HCV Ab) at screening with confirmatory HCV RNA positive;
• •10. Has any abnormal laboratory results including: neutrophil \<1×109/L, serum creatinine \> ULN, ALT or AST \>1.5×ULN, hemoglobin \< 11g/dL;
• •11. Has any medical history or clinical manifestations of any physical or mental illness that may affect the subject's completion of this study;
• •12. 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;
• •13. Needle phobia;
• •14. Have contraindications for intramuscular administration such as confirmed thrombocytopenia, any coagulation dysfunction or currently receiving anticoagulation therapy;
• •15. The investigator considers that he/she is not suitable to participate in this trial.