ICVAX as a HIV Therapeutic DNA Vaccine

Korábbi kezelés

• 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 event 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 for local application only);
• Has contraindications for intramuscular administration such as confirmed thrombocytopenia, any coagulation dysfunction or being receiving anticoagulation therapy

Más betegség

• Has a history of autoimmune diseases; a history of severe allergies, such as urticaria, dyspnea, edema, abdominal pain and other symptoms after administration, especially those who have hypersensitivity to the drug components of this study;
• Infected by chronic hepatitis B virus or hepatitis C virus (HBsAg positive or HCV antibody positive)
• Has any medical history or clinical manifestations of any physical or mental illness that may affect the subject's completion of this study;

Laborértékek

• Has any abnormal laboratory results including: neutrophil <1×109/L, serum creatinine>ULN, ALT or AST>1.5×ULN, hemoglobin<80g/L;

Egyéb

• 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 in the past;
• Sensitive population to stimulation induced by electrical pulses；Implanted with pacemaker or Automatic Implantable Cardioverter Defibrillator (AICD)
• Needle phobia
• The investigator considers that he/she is not suitable to participate in this trial.

• Tested positive for HIV-1 infection;
• Aged 18-50, both male and female;
• Received ART treatment for ≥ 12 months with no occurrence of drug resistance during the 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 at the beginning of ART;
• Adopted contraception method approved by the investigator from 14 days before the first dose to at least 12 weeks after the last dose;
• Understands the study and voluntarily sign the ICF