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

Primary Purpose

Knee Osteoarthritis

Status

Recruiting

Phase

Phase 1

Locations

France

Study Type

Interventional

Intervention

PPV-06 10 μg

PPV-06 50 μg

Placebo

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cic CochinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Low dose

High dose

Arm Description

10 μg + Montanide™ ISA 51 VG

50 μg + Montanide™ ISA 51 VG

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

This secondary outcome measure of this study is to evaluate additional indicators of safety / tolerability

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

This secondary outcome measure of this study is to evaluate additional indicators of safety / tolerability

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

This secondary outcome measure of this study is to evaluate the humoral immune response of PPV-06

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

This secondary outcome measure of this study is to evaluate the humoral immune response of PPV-06

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.

This secondary outcome measure of this study is to evaluate the cellular immune response of PPV-06

The quantification of proliferative CD4+T cells assessed by flow cytometry at Baseline, W24, W32 or early termination.

This secondary outcome measure of this study is to evaluate the cellular immune response of PPV-06

The frequency of hIL-6 epitope-specific memory B cells assessed by ELISPOT assay, at Baseline, W24, W32 or early termination.

This secondary outcome measure of this study is to evaluate the cellular immune response of PPV-06

Full Information

NCT ID

NCT04447898

First Posted

May 4, 2020

Last Updated

April 25, 2022

Sponsor

Peptinov SAS

1. Study Identification

Unique Protocol Identification Number

NCT04447898

Brief Title

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

Official Title

A Randomized, Double-blind, Placebo-controlled, Dose Escalation Phase I Study Assessing the Safety and Immune Response of PPV-06 Vaccine in Patient With Inflammatory Knee Osteoarthritis (KOA)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 18, 2021 (Actual)

Primary Completion Date

February 28, 2023 (Anticipated)

Study Completion Date

February 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peptinov SAS

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Low dose

Arm Type

Experimental

Arm Description

10 μg + Montanide™ ISA 51 VG

Arm Title

High dose

Arm Type

Experimental

Arm Description

50 μg + Montanide™ ISA 51 VG

Intervention Type

Drug

Intervention Name(s)

PPV-06 10 μg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

PPV-06 50 μg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Description

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

Time Frame