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)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Coronavirus Disease (COVID-19)
- Sponsor
- OSE Immunotherapeutics
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- The incidence of solicited local reactogenicity signs and symptoms
- Last Updated
- 4 years ago
Overview
Brief 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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
Exclusion Criteria
- •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
- •Moderate to severe asthma
- •Current tobacco smoking
- •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
Outcomes
Primary Outcomes
The incidence of solicited local 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 incidence of solicited systemic reactogenicity signs and symptoms
Time Frame: up to 7 days after each injection
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
Secondary Outcomes
- Proportion of subjects with significantly increased CD8+ T cells responding to SARS-CoV-2 wild type epitopes(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(At baseline and after each vaccination)
- Geometric mean fold rise of CD8+ T cells responding to SARS-CoV-2 wild type(Day 22, Month 3 and Month 6)
- Change in geometric mean count (GMC) of CD8+ T cells antigen specific to SARS-CoV-2 wild type epitopes(from the pre-injection baseline (Day 1) to Day 22, Week 6, Month 3 and Month 6)