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

NCT04447898 | Completed Phase 1

• 1 other identifier: PPV06-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with DLT defined as grade 3 or higher treatment-related adverse events (monitored in all patients during the study treatment until the End of Study (Week 42) or early termination).

  The primary outcome measure of this study is to evaluate the safety/tolerability of PPV-06 vaccination

  From Baseline to Week 42 (End of Study)

Secondary Outcomes (7)

• The occurrence of all adverse events (AEs) and serious adverse events (SAEs), including clinically significant abnormal haematological and biochemical values (monitored during the entire study period until End of Study (Week 42) or early termination).

  From Baseline to Week 42 (End of Study)

• The quantification of inflammatory markers will be assessed at Baseline, W4, W12, W16, W24, W32 and End of Study (Week 42) or early termination by measuring IL-6, hsCRP and CRPM level in blood

  From Baseline to Week 42 (End of Study)

• The quantification of Anti-IL-6 antibody production, isotypes characterization and anti-CRM197 antibody level in serum at Baseline, W4, W12, W16, W24, W32 and EoS or early termination

  From Baseline to Week 42 (End of Study)

• The quantification of Anti-IL-6 neutralizing antibody level in vitro at W4, W12, W16, W24, W32 and EoS or early termination

  From Baseline to Week 42 (End of Study)

• The quantification of specific T cell response and polarization (Th1, Th2 and Th17) assessed by IFNg, IL-5 and IL-17 Elispot assay at Baseline, W24, W32 or early termination.

  From Baseline to Week 42 (End of Study)

Study Arms (2)

Low dose

EXPERIMENTAL

10 μg + Montanide™ ISA 51 VG

Drug: PPV-06 10 μg; Drug: Placebo

High dose

EXPERIMENTAL

50 μg + Montanide™ ISA 51 VG

Drug: PPV-06 50 μg; Drug: Placebo

Interventions

PPV-06 10 μg DRUG

Low dose + Montanide™ ISA 51 VG in SC administration = 3 injections on Day 0, Day 28, and Day 112

Low dose

PPV-06 50 μg DRUG

High dose+ Montanide™ ISA 51 VG in SC administration = 3 injections on Day 0, Day 28, and Day 112

High dose

Placebo DRUG

Placebo+ Montanide™ ISA 51 VG in SC administration = 3 injections on Day 0, Day 28, and Day 112

High dose; Low dose

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peptinov SAS: lead

Study Sites (1)

Cic Cochin

Paris, France

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: June 25, 2020
• Study Start: February 18, 2021
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: May 31, 2024

Record last verified: 2024-05

Locations

FR (1)