NCT05188469

Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVID and EG-COVARo in Healthy Adult Volunteers

A Phase I/IIa (Multi-center, Open-label, Phase I and Multi-center, Open-label, Phase IIa ) Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVID and EG-COVARo in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: EyeGene Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is Phase 1 and 2a, Multi-center, Open-label study designed to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVID and EG-COVARo vaccine in Healthy Adult Volunteers

Detailed description

Subjects will undergo a Screening period beginning up to 14 days prior to enrollment, the vaccination(s) will be administered on Day 0 and Day 21, pre- and post-dose assessment, follow-up visits, and an end of study (EOS) or early termination (ET) visit (as applicable). Subjects will be enrolled prior to vaccination on Day 0, to one (1) of two (2) or three (3) treatment groups.

Conditions

• COVID-19 Vaccine

Interventions

Type	Name	Description
DRUG	EG-COVID-003	Subjects will receive one, two or three single IM vaccination(s), 3 weeks apart, the subjects will be enrolled to treatment at a ratio of 1:1 (Phase 1: n=10, Phase 2a: 50 per treatment) EG-COVID-003 0.5mL (mRNA 100μg) Route of administration: Intramuscular injection
DRUG	EG-COVID-001	Subjects will receive one, two or three single IM vaccinations, 3 weeks apart, the subjects will be enrolled to treatment at a ratio of 1:1 (Phase 1: n=10, Phase 2a: 50 per treatment) EG-COVID-001 0.5mL (mRNA 200μg) Route of administration: Intramuscular injection
DRUG	A: EG-COVID	Subjects will receive two single IM vaccinations, 3 weeks apart, the subjects will be enrolled to treatment Component Description (per dose): EG-COVID 0.5mL (mRNA 400μg) Route of administration: Intramuscular injection
DRUG	B: EG-COVID	Subjects will receive two single IM vaccination(s), 3 weeks apart, the subjects will be enrolled to treatment Component Description (per dose): EG-COVID 1mL (mRNA 800μg) Route of administration: Intramuscular injection
DRUG	C: EG-COVARo	Subjects will receive two single IM vaccinations, 3 weeks apart, the subjects will be enrolled to treatment Component Description (per dose): EG-COVARo 0.5mL (mRNA 800μg) Route of administration: Intramuscular injection

Timeline

• Start date: 2022-03-22
• Primary completion: 2024-05-29
• Completion: 2025-02-28
• First posted: 2022-01-12
• Last updated: 2025-03-07

Locations

1 site across 1 country: Australia