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

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peptinov SAS

Criteria

Inclusion Criteria:

1. Male or female aged over 40 years;

2. Diagnosis of primary inflammatory Knee Osteoarthritis (KOA),

3. Body mass index (BMI) of 18-32 kg/m2 at screening;

4. Patients with normal organ function at baseline

5. Contraceptives measures

6. In the investigator's opinion, the patient is capable and willing to comply with the requirements of the study;

7. Willing and able to sign a written informed consent;

8. Affiliated to social security insurance.

Exclusion Criteria:

1. Systemic Autoimmune or immunodeficiency disease;

2. Administration of non-steroidal anti-inflammatory drug (NSAID):

3. Administration of prednisone or having intra-articular corticosteroid injection or bolus intramuscular or intravenous treatment with corticosteroids;

4. Patients treated with biologics such as anti-TNFAlpha, anti-IL-6 and anti-CD-20

5. Participation in another investigational drug or vaccine trial;

6. Knee surgery planned before screening and throughout the study;

7. Knee surgery within the year of baseline;

8. Knee trauma within 2 months of baseline;

9. Chronic hepatitis B and/or C infection. Patients with previous infection, resolved in the past, are eligible;

10. HIV-positivity;

11. History of allergic reaction to any constituents of the study drug;

12. Diagnosis or history of any inflammatory arthritis;

13. Neurologic disorders involving the lower limbs;

14. History of malignancy within the last 5 years;

15. Uncontrolled congestive heart failure or hypertension, unstable heart disease

16. 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;

17. Moderate or severe acute illness/infection, persistent diarrhea or vomiting on the day of vaccination;

18. 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;

19. Receipt of immune globulins, blood or blood-derived products;

20. Pregnant or lactating females;

21. The investigator considers the patient unfit for the study as a result of the medical interview, physical examination, or screening investigations.