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

  • STATUS
    Recruiting
  • days left to enroll
    28
  • participants needed
    24
  • sponsor
    Peptinov SAS
Updated on 9 May 2022
body mass index

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.

Details
Condition Knee Osteoarthritis
Treatment Placebo, PPV-06 10 μg, PPV-06 50 μg
Clinical Study IdentifierNCT04447898
SponsorPeptinov SAS
Last Modified on9 May 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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