Status:
COMPLETED
Dose Escalation Study Assessing the Safety and Immune Response of PPV-06 Vaccine
Lead Sponsor:
Peptinov SAS
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40+ years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04447898
Start Date
February 18 2021
End Date
February 28 2023
Last Update
May 31 2024
Active Locations (1)
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1
Cic Cochin
Paris, France