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

Peptinov SAS

Status and phase: Completed; Phase 1

Conditions: Knee Osteoarthritis

Treatments: Drug: PPV-06 50 μg; Drug: Placebo; Drug: PPV-06 10 μg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04447898

PPV06-01

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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24 participants in 2 patient groups

Low dose

Experimental group

Description:

10 μg + Montanide™ ISA 51 VG

Treatment:

Drug: PPV-06 10 μg

Drug: Placebo

High dose

Experimental group

Description:

50 μg + Montanide™ ISA 51 VG

Treatment:

Drug: Placebo

Drug: PPV-06 50 μg