Chronically infected HIV-1 patients under viral control on Anti-Retroviral therapy MedDRA version: 17.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862
Conditions
Interventions
Product Code: VAC-3S
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: IVV-3S
Current Sponsor code: IVV-3S
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Sponsors
InnaVirVax SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Documented HIV-1 infection, 2. Adults > 18 and 200 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Not meeting all of the inclusion criteria listed above, 2. Administration of any investigational drug or device within 28 days prior to screening, 3. Prior history of an AIDS-defining event in the past 5 years, 4. Active co-infection with either HCV or HBV or any other active viral hepatitis co-infection, 5. Any acute or clinically significant infections within the past month, 6. Known allergy or intolerance to components of VAC-3S as documented through medical records or via patient interview, 7. Chronic active liver disease as documented by any of the following laboratory assessments: ultrasound, clinical assessment, liver biopsy or equivalent non-invasive methods, 8. Receipt of any known vaccinations within the past 1 month prior to screening, 9. Receipt of any agent in the past 12 months that exerts a known immunological effect (e.g. includes but not limited to IL-2, IL-7, growth hormone…), 10. Patients with Insulin Dependent Diabetes Mellitus, patients receiving anti-diabetic treatment, anticoagulants (excluding daily “baby-dose” aspirin) or daily NSAIDs within one week of study enrollment, 11. Receipt of any contraindicated medications listed in Appendix 23.2, 12. History of or active auto-immune disease, 13. Acute or chronic psychiatric conditions which in the opinion of the investigator would need continual psychological support and/or medications incompatible with study participation, 14. Patients with contraindications to intramuscular injections including, but not limited to, patients with thrombocytopenia and/or anomalies of the coagulation system, 15. Any uncontrolled chronic or acute condition that in the opinion of the investigator would compromise safety of the patient or the ability to properly administer the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the current Phase 2 study is to evaluate the immunogenicity of VAC-3S at doses of 16 µg, 32 µg and 64 µg at 4 weeks after 3 vaccinations q4weeks in virologically controlled HIV-1 infected patients with CD4+ T cell counts between 200 and 500 cells/mm3 who are receiving standard-of-care antiretroviral treatment.;Secondary Objective: The secondary objectives of the study are: • to evaluate the safety, tolerability and virological impact of anti-3S antibody titers following vaccination with VAC-3S 3 times every 4 weeks, and maintenance vaccinations 3 times every 12 weeks after the initial vaccination schedule; • to evaluate the overall immunogenicity of VAC-3S at doses of 16 µg and 32 µg after 3 maintenance vaccinations at the end of the full immunization scheme; • to evaluate anti-3S antibody decay rates over time; • to assess the impact of VAC-3S immunotherapy on CD4 cell counts and percentages in a cohort of virologically controlled HIV-1 infected patients with stable CD4 cell counts; • to assess the impact of VAC-3S on immunologic markers panels including NKp44L expression on the surface of CD4 T lymphocytes and phenotypic markers of lymphocyte activation and differentiation. • to evaluate the impact of VAC-3S on inflammatory biomarkers. ;Primary end point(s): The primary efficacy endpoint is the change in anti-3S antibody titers after 3 vaccinations q4weeks measured 4 weeks after the third vaccination.;Timepoint(s) of evaluation of this end point: Between week 0 and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Assessment of safety & tolerability • Overall general clinical tolerance, • Local tolerance, • Laboratory monitoring of clinical safety, • CD4, CD8 counts and HIV viral load • HIV RNA monitoring of viral blips. 2. Evaluation of the inflammatory/immunological interface • Impact on chronic inflammatory biomarkers. 3. Assessment of immunogenic characteristics of VAC-3S • Evaluation of the effect of the base immunization schedule of 3 vaccinations at 4-week intervals (total of 3 vaccinations), • Evaluation of the effect of 1, 2 and 3 maintenance vaccinations (a total of 6 vaccinations). 4. Assessment of immunological effects • NKP44L expression, • Immune activation, • Immune differentiation. 5. Evaluation of secondary virological effects • Impact on markers of HIV reservoir. 6. Specific secondary assessments not covered under secondary objectives number 1 to 5: • Characterization of anti-3S antibodies, • Identification of composite endpoints, • Identification of factors predictive of response, • Specific statistical analysis to identify patient subgroups, • Response in subgroups of patients as a function of ongoing treatments [type of ART, statins], • Estimation of the optimal time to re-vaccinate subjects after the last dose of VAC-3S (defined as the median/mean time to an anti-3S antibody titer <50 AU), • Evaluation of increasing doses of VAC-3S on: - Safety/Tolerability of VAC-3S, - Maximum anti-3S antibody titers, - Time to reach the maximum anti-3S antibody titer, - Decay of anti-3S antibody titers over time after the last vaccination with VAC-3S, • Evaluation of the impact of different levels of CD4+ T cell count on the: - Safety/Tolerability of VAC-3S, - Maximum anti-3S antibody titer, - Time to reach the maximum anti-3S antibody titer, - Decay of anti-3S antibody titers over time after the last dose of VAC-3S. • Evaluation of the effect of the maximum anti-3S antibody titer on: - Safety/tolerability, - Time to decay based upon an init | — |
Countries
France, Germany, Spain
Contacts
Public ContactRaphaël Ho Tsong Fang, DVM, PhD
InnaVirVax SA
Outcome results
None listed