PPV-06 immunotherapy targets interleukin-6 (IL-6), a key molecule of the immune system whose overproduction is implicated in many inflammatory and autoimmune diseases such as rheumatoid arthritis and osteoarthritis. The benefit of vaccination with PPV-06 is to induce, in response to immunizations, the production of antibodies directed against IL-6. The antibodies produced will neutralize the biological activity of IL-6 involved in the body's inflammatory process. The primary objective is to evaluate the safety/tolerability of vaccination with PPV-06.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
24
Low dose + Montanide™ ISA 51 VG in SC administration = 3 injections on Day 0, Day 28, and Day 112
High dose+ Montanide™ ISA 51 VG in SC administration = 3 injections on Day 0, Day 28, and Day 112
Placebo+ Montanide™ ISA 51 VG in SC administration = 3 injections on Day 0, Day 28, and Day 112
Cic Cochin
Paris, France
The proportion of patients with DLT defined as grade 3 or higher treatment-related adverse events (monitored in all patients during the study treatment until the End of Study (Week 42) or early termination).
The primary outcome measure of this study is to evaluate the safety/tolerability of PPV-06 vaccination
Time frame: From Baseline to Week 42 (End of Study)
The occurrence of all adverse events (AEs) and serious adverse events (SAEs), including clinically significant abnormal haematological and biochemical values (monitored during the entire study period until End of Study (Week 42) or early termination).
This secondary outcome measure of this study is to evaluate additional indicators of safety / tolerability
Time frame: From Baseline to Week 42 (End of Study)
The quantification of inflammatory markers will be assessed at Baseline, W4, W12, W16, W24, W32 and End of Study (Week 42) or early termination by measuring IL-6, hsCRP and CRPM level in blood
This secondary outcome measure of this study is to evaluate additional indicators of safety / tolerability
Time frame: From Baseline to Week 42 (End of Study)
The quantification of Anti-IL-6 antibody production, isotypes characterization and anti-CRM197 antibody level in serum at Baseline, W4, W12, W16, W24, W32 and EoS or early termination
This secondary outcome measure of this study is to evaluate the humoral immune response of PPV-06
Time frame: From Baseline to Week 42 (End of Study)
The quantification of Anti-IL-6 neutralizing antibody level in vitro at W4, W12, W16, W24, W32 and EoS or early termination
This secondary outcome measure of this study is to evaluate the humoral immune response of PPV-06
Time frame: From Baseline to Week 42 (End of Study)
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The quantification of specific T cell response and polarization (Th1, Th2 and Th17) assessed by IFNg, IL-5 and IL-17 Elispot assay at Baseline, W24, W32 or early termination.
This secondary outcome measure of this study is to evaluate the cellular immune response of PPV-06
Time frame: From Baseline to Week 42 (End of Study)
The quantification of proliferative CD4+T cells assessed by flow cytometry at Baseline, W24, W32 or early termination.
This secondary outcome measure of this study is to evaluate the cellular immune response of PPV-06
Time frame: From Baseline to Week 42 (End of Study)
The frequency of hIL-6 epitope-specific memory B cells assessed by ELISPOT assay, at Baseline, W24, W32 or early termination.
This secondary outcome measure of this study is to evaluate the cellular immune response of PPV-06
Time frame: From Baseline to Week 42 (End of Study)