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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HIV

Intervention / Treatment
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* Biological: VAC-3S


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VAC-3S<br>32µg/ml corresponding to 16µg/vaccination | Biological: VAC-3S<br>* Administered via intra-muscular injection in the arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who tolerated 3 vaccinations with VAC-3S 16µg/mL at 4-weeks interval determined by safety parameter changes according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table. |  | From Day 0 to week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who tolerated a fourth booster injection of VAC-3S 16µg/mL determined by safety parameter changes according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) Adverse Events (AE) Grading Table. |  | From Week 16 to Week 48 | 
| Anti-3S antibody titers |  | From Day 0 to Week 48 | 
| Markers of progression to AIDS. Markers include CD4+ cell count, viral load, and phenotypic markers of lymphocyte differentiation and activation |  | From Day 0 to Week 48 |