Coronavirus Disease (COVID-19) Clinical Trial
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. 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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04583982 -
ImmuneSense™ COVID-19 Study
|
||
| Completed |
NCT04609774 -
Aerosol Transmission of Severe Acute Respiratory Syndrome Coronavirus of Coronavirus Disease 2019
|
||
| Terminated |
NCT04569786 -
Dose Ranging Trial to Assess Safety and Immunogenicity of V590 (COVID-19 Vaccine) in Healthy Adults (V590-001)
|
Phase 1 | |
| Terminated |
NCT04575584 -
Efficacy and Safety of Molnupiravir (MK-4482) in Hospitalized Adult Participants With COVID-19 (MK-4482-001)
|
Phase 2/Phase 3 | |
| Completed |
NCT04575597 -
Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002)
|
Phase 2/Phase 3 | |
| Recruiting |
NCT04572360 -
Cardiorespiratory Exercise & Chinese Medicine for Rehabilitation of Discharged Coronavirus Disease (COVID-19) Patients
|
N/A | |
| Not yet recruiting |
NCT04360122 -
Levamisole and Isoprinosine in Immune-prophylaxis of Egyptian Healthcare Workers Facing COVID-19
|
Phase 3 | |
| Completed |
NCT05119855 -
Safety and Immunogenicity of 9-valent Human Papillomavirus (9vHPV) Vaccine Coadministered With Messenger Ribonucleic Acid (mRNA)-1273 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (COVID-19) Vaccine (V503-076)
|
Phase 3 | |
| Completed |
NCT04558307 -
Feasibility of Rapid COVID-19 Testing in Disadvantaged Populations
|
||
| Recruiting |
NCT04584606 -
Ain Shams University Experience: Clinical Determinants of Hospitalized COVID-19 Patients
|
||
| Completed |
NCT04677660 -
A Study of TAK-919 in Healthy Japanese Adults (COVID-19)
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT04280588 -
Fingolimod in COVID-19
|
Phase 2 | |
| Completed |
NCT04941144 -
Long-Term Follow-up Survey of COVID-19 Vaccine After Vaccination
|
||
| Terminated |
NCT04498247 -
A Study to Assess Safety, Tolerability, and Immunogenicity of V591 (COVID-19 Vaccine) in Healthy Participants (V591-001)
|
Phase 1/Phase 2 | |
| Completed |
NCT04939428 -
Study of MK-4482 for Prevention of Coronavirus Disease 2019 (COVID-19) in Adults (MK-4482-013)
|
Phase 3 | |
| Withdrawn |
NCT04892888 -
Survey of the Moderna COVID-19 Vaccine in People at High-Risk of Developing Severe COVID-19 Symptoms
|
||
| Completed |
NCT04348214 -
Screening & Risk Assessment of Healthcare Workers & Infection Control in University & COVID-19 Quarantine Hospitals
|
||
| Not yet recruiting |
NCT04348877 -
Plasma Rich Antibodies From Recovered Patients From COVID19
|
N/A | |
| Not yet recruiting |
NCT04350931 -
Application of BCG Vaccine for Immune-prophylaxis Among Egyptian Healthcare Workers During the Pandemic of COVID-19
|
Phase 3 | |
| Not yet recruiting |
NCT04346043 -
To Access the Egyptian COVID-19 Whole Genome by NGS and Compare to the International Worldwide Database
|