Open-label, Phase I/IIa Study of VAC-3S in HIV-1 Patients Who Showed an Immune Response to VAC-3S During IVVAC-3S/P1

Multicentre, Open-label, Phase I/IIa Clinical Study of an Immunoprotective Therapeutic Vaccine Candidate (VAC-3S) in Human Immunodeficiency Virus Type 1 (HIV-1) Chronically Infected Patients Virologically Controlled on Antiretroviral Therapy (ART) Who Rose an Immune Response to VAC-3S During IVVAC-3S/P1

The purpose of this study is to evaluate the safety and tolerability of VAC-3S in controlled HIV patients receiving standard of care antiretroviral treatment.

Inclusion Criteria:

• HIV-1 infected patient,
• Age between 18 and 60 years,
• ART (Anti Retroviral Therapy) initiation ≥ 1 year ago,
• Plasma HIV RNA ≤ 200 copies/ml in the past 12 months,
• Plasma HIV RNA ≤ 50 copies/ml at the screening visit,
• CD4+ T cell count ≥ 200 cells/mm3,
• Nadir CD4+ T cell count ≥ 100 cells/mm3,
• Contraception in women with child-bearing potential,
• A total anti-3S titer ≥ 20 A.U. at any time point of IVVAC-3S/P1 clinical trial,
• Per protocol subject having completed the IVVAC-3S/P1 study.
• Patient affiliated to a social security system,
• Patient who has understood the protocol design and provided a signed written informed consent form,
• Patient who is willing and capable of cooperating to the extent and degree required by the protocol,
• Patient whom the investigator believes he/she can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) and he/she will be available for all scheduled visits at the investigational site.

Exclusion Criteria:

• Administration of VAC-3S in the past year,
• Chronic active liver disease,
• History of HCV co-infection or ongoing replicating HCV (positive RT-PCR) or HBV (positive HbS Ag) coinfection,
• Any immunotherapy (e.g. IL-2, IL-7, growth hormone…) in the past year at the exception of VAC-3S,
• Any immunosuppressive therapy (glucocorticoids, cyclosporine, methotrexate) or chronic non-steroidal anti-inflammatory treatment in the past month,
• Ongoing pregnancy,
• Breastfeeding women,
• Patient with known sensitivities to investigational drug (see please the CIB),
• History of allergy to any vaccine,
• Any severe chronic condition that would interfere with the study,
• History of auto-immune disease,
• Organ transplant,
• Splenectomy,
• Psychiatric disorder significant enough to hinder participation as assessed by the investigator,
• Patient who has participated in a clinical research trial in the 30 days preceding the screening visit (V-1M-1).
• Patients with contraindications to intramuscular injections including, but not limited to, patients with thrombocytopenia and/or anomalies of the coagulation system,
• Any uncontrolled chronic or acute condition that in the opinion of the investigator would compromise the safety of the patient or the ability to properly administer the study.