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

NCT05188469 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2025-03-07

No results posted yet for this study

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

Conditions

  • COVID-19 Vaccine

Interventions

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

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • EyeGene Inc.

    lead OTHER

Principal Investigators

  • Mark Bloch, A/Prof · Holdsworth House

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-22
Primary Completion
2024-05-29
Completion
2025-02-28

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05188469 on ClinicalTrials.gov