Chronically infected HIV-1 patients under viral control on Anti-Retroviral therapy. MedDRA version: 18.0 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862
Conditions
Interventions
Product Code: VAC-3S
Pharmaceutical Form: Suspension for injection
Sponsors
InnaVirVax
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - HIV-1 infected patient - Age between 18 and 60 years - ART (AntiRetroviral Therapy) initiation ? 1 year ago - Plasma HIV RNA =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Chronic active liver disease, 2. History of HCV co-infection or ongoing replicating HCV (positive RT-PCR) or HBV (positive HbS Ag) coinfection, 3. Any immunotherapy (e.g. IL-2, IL-7, growth hormone…) in the past year at the exception of VAC-3S, 4. Any immunosuppressive therapy (glucocorticoids, cyclosporine, methotrexate) or chronic non-steroidal anti-inflammatory treatment in the past month, 5. Ongoing pregnancy, 6. Breastfeeding women, 7. Patient with known sensitivities to investigational drug (see please the CIB), 8. History of allergy to any vaccine, 9. Any severe chronic condition that would interfere with the study, 10. History of auto-immune disease, 11. Organ transplant, 12. Splenectomy, 13. Psychiatric disorder significant enough to hinder participation as assessed by the investigator, 14. Patient who has participated in a clinical research trial in the 30 days preceding the screening visit (V-1M-1). 15. Patients with contraindications to intramuscular injections including, but not limited to, patients with thrombocytopenia and/or anomalies of the coagulation system, 16. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess safety and tolerability of three intramuscular injections of VAC-3S at 16 µg of peptide equivalent/vaccination administered in 4-weeks intervals from D0 to the interim analysis time point (V5M4).;Secondary Objective: • To assess the safety and tolerability of a fourth injection of VAC-3S 20 weeks after the first injection, in the patients who did not reach total anti-3S antibody titers above 500 Arbitrary Units (A.U.). • To assess the immunogenicity of three intramuscular injections of VAC-3S at 16 µg of peptide equivalent/vaccination administered at 4-week intervals from D0 till the interim analysis time point (V5M4). • To assess the immunogenicity of a fourth injection of VAC-3S 20 weeks after the first injection, in the patients who did not rise total anti-3S antibody titers above 500 Arbitrary Units (A.U.) • To assess the time course of markers of progression to AIDS. Markers include CD4/CD8 ratio, CD4+ and CD8+ cell counts and percentages, viral load, phenotypic markers lymphocyte cell differentiation and activation, serum activation markers and HIV DNA bulk from D0 to the final analysis time point.;Primary end point(s): Occurence of any local or systemic adverse event from baseline to the interim analysis time point based on clinical and laboratory monitoring.;Timepoint(s) of evaluation of this end point: At week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - HIV plasma viral load (number of HIV RNA copies/mL) measured by quantitative RT-PCR from baseline to the final analysis time point. - The occurrence of any AE between the interim analysis time point and the final analysis time point. - Anti-3S Ab titers (IgM, IgA or IgG) using ELISA from baseline to the final analysis time point. - CD4+/CD8+ ratio from baseline to the final analysis time point. - CD4+ and CD8+ T cell counts and percentages, and T lymphocyte markers of differentiation and activation using immunophenotyping from D0 to the final analysis time point. - Serum inflammation nmarkers, - HIV DNA bulk;Timepoint(s) of evaluation of this end point: Week 51 | — |
Countries
France
Contacts
Public ContactRaphaël Ho Tsong Fang, DVM, PhD
InnaVirVax
Outcome results
None listed