To Evaluate the Safety, and Immunogenicity of Vaccine Candidate Against COVID-19, in Healthy Adults

NCT04885361 | Unknown Phase 1 DMC

• 1 other identifier: OSE-13E-C102
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Disease (COVID-19)

Outcome Measures

Primary Outcomes (6)

• The incidence of solicited local reactogenicity signs and symptoms

  up to 7 days after each injection

• The incidence of solicited systemic reactogenicity signs and symptoms

  up to 7 days after each injection

• The incidence of unsolicited adverse events in study participants.

  up to 28 days after each vaccination.

• The occurrence of serious adverse events (SAE).

  throughout study completion, an average of 6 months.

• The occurrence of adverse events of special interest (AESI), including potentially immune mediated disorders (pIMD)

  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

  Week 6

Secondary Outcomes (4)

• Proportion of subjects with significantly increased CD8+ T cells responding to SARS-CoV-2 wild type epitopes

  Day 22, Month 3 and Month 6

• Geometric mean fold rise of CD8+ T cells responding to SARS-CoV-2 wild type

  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

• 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

Study Arms (2)

Arm 1 injection

EXPERIMENTAL

The dose of 1 ml will be administered subcutaneously, preferably into deltoid region of the non-dominant arm.

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.

Biological: CoVepiT (OSE13E)

Interventions

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.

Arm 1 injection; Arm 2 injections separated by 21 days

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• OSE Immunotherapeutics: lead

Study Sites (1)

Center for Vaccinology (CEVAC),

Ghent, Belgium

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Ose immunotherapeutics

CONTACT

01 43 29 78 57; contact@ose-immuno.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 13, 2021
• Study Start: May 26, 2021
• Primary Completion: September 30, 2021
• Study Completion: March 31, 2022
• Last Updated: June 9, 2021

Record last verified: 2021-06

Locations

BE (1)