Dose Escalation Study Assessing the Safety and Immune Response of PPV-06 Vaccine

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.