Title
Dose Escalation Study Assessing the Safety and Immune Response of PPV-06 Vaccine
A Randomized, Double-blind, Placebo-controlled, Dose Escalation Phase I Study Assessing the Safety and Immune Response of PPV-06 Vaccine in Patient With Inflammatory Knee Osteoarthritis (KOA)
Phase
Phase 1Lead Sponsor
Peptinov SASStudy Type
InterventionalStatus
RecruitingIndication/Condition
Knee OsteoarthritisIntervention/Treatment
PPV-06 10 μg PPV-06 50 μg ...Study Participants
24PPV-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.
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
Inclusion Criteria: Male or female aged over 40 years; Diagnosis of primary inflammatory Knee Osteoarthritis (KOA), Body mass index (BMI) of 18-32 kg/m2 at screening; Patients with normal organ function at baseline Contraceptives measures In the investigator's opinion, the patient is capable and willing to comply with the requirements of the study; Willing and able to sign a written informed consent; Affiliated to social security insurance. Exclusion Criteria: Systemic Autoimmune or immunodeficiency disease; Administration of non-steroidal anti-inflammatory drug (NSAID): Administration of prednisone or having intra-articular corticosteroid injection or bolus intramuscular or intravenous treatment with corticosteroids; Patients treated with biologics such as anti-TNFAlpha, anti-IL-6 and anti-CD-20 Participation in another investigational drug or vaccine trial; Knee surgery planned before screening and throughout the study; Knee surgery within the year of baseline; Knee trauma within 2 months of baseline; Chronic hepatitis B and/or C infection. Patients with previous infection, resolved in the past, are eligible; HIV-positivity; History of allergic reaction to any constituents of the study drug; Diagnosis or history of any inflammatory arthritis; Neurologic disorders involving the lower limbs; History of malignancy within the last 5 years; Uncontrolled congestive heart failure or hypertension, unstable heart disease Evidence of any clinically significant abnormality on a chest X-ray which, in the opinion of the investigator, could represent active infection or latent tuberculosis; Moderate or severe acute illness/infection, persistent diarrhea or vomiting on the day of vaccination; Received any licensed, non-live vaccine within the 14 days before receipt of any dose of the study vaccine or is scheduled to receive any licensed, non-live vaccine within 30 days following receipt of any dose of the study vaccine; Receipt of immune globulins, blood or blood-derived products; Pregnant or lactating females; The investigator considers the patient unfit for the study as a result of the medical interview, physical examination, or screening investigations.
