Coronavirus Disease (COVID-19)Phase 1COVEPIT 3NCT04885361
To Evaluate the Safety, and Immunogenicity of Vaccine Candidate Against COVID-19, in Healthy Adults
A Phase 1 study testing CoVepiT (OSE13E) in people with Coronavirus Disease (COVID-19), run by OSE Immunotherapeutics at 1 site in Belgium.
Trial summary
The proposed study is a phase 1 study which will evaluate the safety, reactogenicity and immunogenicity of two doses regimen of CoVepiT vaccine (OSE-13E) in the population of n=48 healthy volunteers 18 to 45 (inclusive) years old, vaccinated or not by authorized COVID-19 vaccine. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Disease (COVID-19)
- What is being tested?
- CoVepiT (OSE13E)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- 26 May 2021to 31 Mar 2022
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject's meeting all the following criteria are eligible to participate in this study:
- Males or females 18 to 45 (inclusive) years of age, at screening.
- Healthy participants as determined based on medical history, clinical laboratory results, vital sign measurements, and physical examination at screening.
- Subjects not previously vaccinated with any COVID-19 vaccine OR Subjects who have completed the vaccination according to an officially accepted scheme (e.g., healthcare workers), at least 4 weeks prior to enrollment, with an authorized vaccine which induces neutralizing antibodies against the SARS-CoV-2 Spike protein.
- Willing and able to give informed consent.
- Willing to accept following contraceptive measures:
Who cannot join
- Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care, inclusive of changes in medication in the past 2 months (at the discretion of the investigator). This includes any current workup of undiagnosed illness that could lead to a new condition, including but not limited to any of the following conditions that are risk factors of severe illness from the virus that causes COVID-19:
- Active cancer (malignancy) within 5 years prior to first study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma, at the discretion of the investigator)
- Chronic kidney disease
- COPD
- Moderate to severe asthma
- Current tobacco smoking
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- People who have had an organ transplant.
- Heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies
- BMI ≥ 30 kg/m2 or BMI <17 kg/m2
- Type 2 diabetes mellitus
- Chronic liver disease
- Sickle cell disease Hypertension
- Type 1 diabetes
- Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
- Participation in research involving an investigational product (drug/biologic/device) within 45 days prior to first study vaccination.
- History of a confirmed diagnosis of SARS, MERS or COVID-19 disease (confirmed by a specific test for each disease) or known exposure during 2-4 weeks prior to enrollment to a SARS-CoV-2 positive confirmed close contact (eg, family member, housemate, daycare provider, aged parent requiring care), at the discretion of the investigator.
- Professionals involved in direct care of the COVID-19 patients and with a high risk of exposure to SARS-CoV-2 (i.e., healthcare worker of intensive care unit at infectology department ).
- Currently taking any product (investigational or off-label) for prevention of COVID-19 disease.
- Positive rapid test for SARS-CoV-2 (ELISA or PCR) at screening or prior to first vaccination.
- Received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine within 4 weeks prior to first study vaccination. NOTE: COVID-19 marketed vaccines may be allowed as long inclusion criterion #3 is met.
- Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital).
- Chronic administration (defined as more than 14 continuous days) of immunosuppressant, systemic glucocorticosteroids, or other immune-modifying drugs within 4 months prior to first study vaccination or anticipation of the need for immunosuppressive treatment within 6 months after last vaccination.
- Received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days prior to first study vaccination.
- Any acute illness concurrent or within 14 days prior to first study vaccination (medical history and/or physical examination) or documented temperature of ≥38°C during this period. This includes respiratory or constitutional symptoms consistent with SARS-CoV-2 (COVID-19) (ie, cough, sore throat, difficulty breathing)
- Known disturbance of coagulation (iatrogenic or congenital). NOTE: The use of ≤325 mg of aspirin per day as prophylaxis is permitted, but the use of other platelet aggregation inhibitors, thrombin inhibitors, Factor Xa inhibitors, or warfarin derivatives is exclusionary, regardless of bleeding history, because these imply treatment or prophylaxis of known cardiac or vascular disease.
- Any neurological disease or history of significant neurological disorder (eg, meningitis, seizures, multiple sclerosis, vasculitis, migraines, Guillain-Barré syndrome [genetic/congenital or acquired]).
- Vital sign (blood pressure, pulse, temperature) abnormalities of toxicity grade >1
- Clinical laboratory abnormalities of toxicity grade >1 for selected serum chemistry and hematology parameters
- Any known allergies to products contained in the investigational product or latex allergy, or history of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention.
- Women who are pregnant, breastfeeding or who plan to become pregnant during the study.
- History of alcohol abuse or drug addiction within one year prior to the first study vaccination.
- Any condition that, in the opinion of the investigator, would pose a health risk to the subject if enrolled or could interfere with evaluation of the study vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).
- Study team member or first-degree relative of any study team member (inclusive of sponsor or delegate, and site personnel involved in the study).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Phase 1 Study to Evaluate the Safety, Reactogenicity and Immunogenicity of OSE-13E, a Multiepitope-based Vaccine Candidate Against COVID-19, in Healthy Adults (COVEPIT-3)
The proposed study is a phase 1 study which will evaluate the safety, reactogenicity and immunogenicity of two doses regimen of CoVepiT vaccine (OSE-13E) in the population of n=48 healthy volunteers 18 to 45 (inclusive) years old, vaccinated or not by authorized COVID-19 vaccine.
Study will be open label and will be randomized 1:1 in two parallel study arms receiving either one single dose or two doses separated by 21 days.
Read more
First 4 subjects will serve as sentinel cohort and 7 days reactogenicity data of these subjects will be reviewed by the independent safety monitoring committee (SMC) before proceeding to the vaccination of remaining volunteers. The progress of the study will be overviewed by a safety monitoring committee (SMC).
The CoVepiT vaccine is a peptide-based vaccine aiming to induce CD8+T-cell-mediated immune response against 11 different proteins of SARS-CoV-2 virus.
- Conditions
- Coronavirus Disease (COVID-19)
- Being tested
- CoVepiT (OSE13E)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoVepiT (OSE13E)Biological
Study will be open label and will be randomized 1:1 in two parallel study arms receiving either one single dose or two doses separated by 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 injection | Experimental | The dose of 1 ml will be administered subcutaneously, preferably into deltoid region of the non-dominant arm. Receives: Biological: CoVepiT (OSE13E) |
| Arm 2 injections separated by 21 days | Experimental | The dose of 1 ml will be administered subcutaneously, preferably into deltoid region of the non-dominant arm. Receives: Biological: CoVepiT (OSE13E) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of solicited local reactogenicity signs and symptoms
Measured: up to 7 days after each injection
The incidence of solicited systemic reactogenicity signs and symptoms
Measured: up to 7 days after each injection
The incidence of unsolicited adverse events in study participants.
Measured: up to 28 days after each vaccination.
The occurrence of serious adverse events (SAE).
Measured: throughout study completion, an average of 6 months.
The occurrence of adverse events of special interest (AESI), including potentially immune mediated disorders (pIMD)
Measured: throughout study completion, an average of 6 months.
Proportion of subjects with significantly increased CD8+ T cells responding to SARS-CoV-2 wild type epitopes at Week 6 - 1 versus 2 doses
Measured: Week 6
Secondary outcomes (4)
Proportion of subjects with significantly increased CD8+ T cells responding to SARS-CoV-2 wild type epitopes
Measured: Day 22, Month 3 and Month 6
Geometric mean fold rise of CD8+ T cells responding to SARS-CoV-2 wild type
Measured: Day 22, Month 3 and Month 6
Proportion of participants achieving ≥2-fold rise of secreting spots specific to SARS-CoV-2 wild type epitopes
Measured: At baseline and after each vaccination
Change in geometric mean count (GMC) of CD8+ T cells antigen specific to SARS-CoV-2 wild type epitopes
Measured: from the pre-injection baseline (Day 1) to Day 22, Week 6, Month 3 and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start26 May 2021
- Primary completion30 Sep 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease (COVID-19)Studies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OSE Immunotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885361
- Sponsor's protocol ID
- OSE-13E-C102
- Acronym
- COVEPIT 3
- Status last verified
- Jun 2021
- First submitted
- 7 May 2021
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Phase 1 Study to Evaluate the Safety, Reactogenicity and Immunogenicity of OSE-13E, a Multiepitope-based Vaccine Candidate Against COVID-19, in Healthy Adults (COVEPIT-3)
- ClinicalTrials.gov ID
- NCT04885361
- Acronym / sponsor ID
- COVEPIT 3 / OSE-13E-C102
- Conditions
- Coronavirus Disease (COVID-19)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- OSE ImmunotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 26 May 2021 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 13 May 2021 (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.
The proposed study is a phase 1 study which will evaluate the safety, reactogenicity and immunogenicity of two doses regimen of CoVepiT vaccine (OSE-13E) in the population of n=48 healthy volunteers 18 to 45 (inclusive) years old, vaccinated or not by authorized COVID-19 vaccine.
Study will be open label and will be randomized 1:1 in two parallel study arms receiving either one single dose or two doses separated by 21 days.
First 4 subjects will serve as sentinel cohort and 7 days reactogenicity data of these subjects will be reviewed by the independent safety monitoring committee (SMC) before proceeding to the vaccination of remaining volunteers. The progress of the study will be overviewed by a safety monitoring committee (SMC).
The CoVepiT vaccine is a peptide-based vaccine aiming to induce CD8+T-cell-mediated immune response against 11 different proteins of SARS-CoV-2 virus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 injection | Experimental | Biological: CoVepiT (OSE13E)The dose of 1 ml will be administered subcutaneously, preferably into deltoid region of the non-dominant arm. |
| Arm 2 injections separated by 21 days | Experimental | Biological: CoVepiT (OSE13E)The dose of 1 ml will be administered subcutaneously, preferably into deltoid region of the non-dominant arm. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males or females 18 to 45 (inclusive) years of age, at screening.
- Healthy participants as determined based on medical history, clinical laboratory results, vital sign measurements, and physical examination at screening.
- Subjects not previously vaccinated with any COVID-19 vaccine OR Subjects who have completed the vaccination according to an officially accepted scheme (e.g., healthcare workers), at least 4 weeks prior to enrollment, with an authorized vaccine which induces neutralizing antibodies against the SARS-CoV-2 Spike protein.
- Willing and able to give informed consent.
- Willing to accept following contraceptive measures:
Key exclusion criteria (33 listed)
- Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care, inclusive of changes in medication in the past 2 months (at the discretion of the investigator). This includes any current workup of undiagnosed illness that could lead to a new condition, including but not limited to any of the following conditions that are risk factors of severe illness from the virus that causes COVID-19:
- Type 1 diabetes
- Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
- Participation in research involving an investigational product (drug/biologic/device) within 45 days prior to first study vaccination.
- History of a confirmed diagnosis of SARS, MERS or COVID-19 disease (confirmed by a specific test for each disease) or known exposure during 2-4 weeks prior to enrollment to a SARS-CoV-2 positive confirmed close contact (eg, family member, housemate, daycare provider, aged parent requiring care), at the discretion of the investigator.
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 |
|---|---|---|
| CoVepiT (OSE13E)Study will be open label and will be randomized 1:1 in two parallel study arms receiving either one single dose or two doses separated by 21 days. | Biological | Arm 1 injection, Arm 2 injections separated by 21 days |
Primary outcome
The incidence of solicited local reactogenicity signs and symptoms
Time frame: up to 7 days after each injection
The incidence of solicited systemic reactogenicity signs and symptoms
Time frame: up to 7 days after each injection
The incidence of unsolicited adverse events in study participants.
Time frame: up to 28 days after each vaccination.
The occurrence of serious adverse events (SAE).
Time frame: throughout study completion, an average of 6 months.
The occurrence of adverse events of special interest (AESI), including potentially immune mediated disorders (pIMD)
Time frame: throughout study completion, an average of 6 months.
Proportion of subjects with significantly increased CD8+ T cells responding to SARS-CoV-2 wild type epitopes at Week 6 - 1 versus 2 doses
Time frame: Week 6
4 secondary outcomes
Proportion of subjects with significantly increased CD8+ T cells responding to SARS-CoV-2 wild type epitopes
Time frame: Day 22, Month 3 and Month 6
Geometric mean fold rise of CD8+ T cells responding to SARS-CoV-2 wild type
Time frame: Day 22, Month 3 and Month 6
Proportion of participants achieving ≥2-fold rise of secreting spots specific to SARS-CoV-2 wild type epitopes
Time frame: At baseline and after each vaccination
Change in geometric mean count (GMC) of CD8+ T cells antigen specific to SARS-CoV-2 wild type epitopes
Time frame: from the pre-injection baseline (Day 1) to Day 22, Week 6, Month 3 and Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
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 CoVepiT (OSE13E) in people with Coronavirus Disease (COVID-19), run by OSE Immunotherapeutics at 1 site in Belgium.
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 6 inclusion and 33 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: status not confirmed, as of the sponsor's last update on 9 Jun 2021. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ose immunotherapeutics (01 43 29 78 57, contact@ose-immuno.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of solicited local reactogenicity signs and symptoms (time frame: up to 7 days after each injection). The study lists 6 primary outcomes in all. 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 9 Jun 2021.