Knee OsteoarthritisPhase 1NCT04447898
Dose Escalation Study Assessing the Safety and Immune Response of PPV-06 Vaccine
A Phase 1 study testing PPV-06 10 μg and PPV-06 50 μg in people with Knee Osteoarthritis, run by Peptinov SAS at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- PPV-06 10 μg and PPV-06 50 μg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 18 Feb 2021to 28 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
- Being tested
- PPV-06 10 μg, PPV-06 50 μg, Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPV-06 10 μgDrug
Low dose + Montanide™ ISA 51 VG in SC administration = 3 injections on Day 0, Day 28, and Day 112
PPV-06 50 μgDrug
High dose+ Montanide™ ISA 51 VG in SC administration = 3 injections on Day 0, Day 28, and Day 112
PlaceboDrug
Placebo+ Montanide™ ISA 51 VG in SC administration = 3 injections on Day 0, Day 28, and Day 112
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | 10 μg + Montanide™ ISA 51 VG Receives: Drug: PPV-06 10 μg; Drug: Placebo |
| High dose | Experimental | 50 μg + Montanide™ ISA 51 VG Receives: Drug: PPV-06 50 μg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
This secondary outcome measure of this study is to evaluate additional indicators of safety / tolerability
Measured: 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
This secondary outcome measure of this study is to evaluate additional indicators of safety / tolerability
Measured: 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
This secondary outcome measure of this study is to evaluate the humoral immune response of PPV-06
Measured: 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
This secondary outcome measure of this study is to evaluate the humoral immune response of PPV-06
Measured: 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.
This secondary outcome measure of this study is to evaluate the cellular immune response of PPV-06
Measured: From Baseline to Week 42 (End of Study)
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
Measured: From Baseline to Week 42 (End of Study)
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
Measured: From Baseline to Week 42 (End of Study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start18 Feb 2021
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peptinov SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447898
- Sponsor's protocol ID
- PPV06-01
- Status last verified
- May 2024
- First submitted
- 4 May 2020
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04447898
- Acronym / sponsor ID
- PPV06-01
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Peptinov SASIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: PPV-06 10 μg, Drug: Placebo10 μg + Montanide™ ISA 51 VG |
| High dose | Experimental | Drug: PPV-06 50 μg, Drug: Placebo50 μg + Montanide™ ISA 51 VG |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPV-06 10 μgLow dose + Montanide™ ISA 51 VG in SC administration = 3 injections on Day 0, Day 28, and Day 112 | Drug | Low dose |
| PPV-06 50 μgHigh dose+ Montanide™ ISA 51 VG in SC administration = 3 injections on Day 0, Day 28, and Day 112 | Drug | High dose |
| PlaceboPlacebo+ Montanide™ ISA 51 VG in SC administration = 3 injections on Day 0, Day 28, and Day 112 | Drug | High dose, Low dose |
Primary outcome
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).
Time frame: From Baseline to Week 42 (End of Study)
The primary outcome measure of this study is to evaluate the safety/tolerability of PPV-06 vaccination
7 secondary outcomes
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).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: From Baseline to Week 42 (End of Study)
The quantification of proliferative CD4+T cells assessed by flow cytometry at Baseline, W24, W32 or early termination.
Time frame: From Baseline to Week 42 (End of Study)
The frequency of hIL-6 epitope-specific memory B cells assessed by ELISPOT assay, at Baseline, W24, W32 or early termination.
Time frame: From Baseline to Week 42 (End of Study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Knee Osteoarthritis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
RecruitingPhase 2
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
Osteoarthritis of Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PPV-06 10 μg and PPV-06 50 μg in people with Knee Osteoarthritis, run by Peptinov SAS at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: From Baseline to Week 42 (End of Study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.