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Safety and Immunogenicity Study of EgyVax Vaccine Candidate for Prophylaxis of COVID-19 Infection

NCT05218070 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2022-02-23

No results posted yet for this study

Summary

This is a phase I, prospective, three-arm, open-label, randomized, first in human (FIH) clinical trial to assess the safety and immunogenicity of EgyVax vaccine candidate for prophylaxis of SARS-CoV-2 infection (COVID-19).

Conditions

Interventions

DRUG

EgyVax Vaccine Candidate

EgyVax Inactivated SARS-CoV-2 vaccine candidate, equivalent to 70 mcg inactivated SARS-CoV-2 total protein. Alum adjuvant 2% 50 µl (equivalent to 0.5 mg AlOH). Equivalent volume of Saline 0.9% to each vaccine dose. Each vial contains 0.5 ml representing one dose 70 mcg of inactivated SARS-CoV-2 virus with alum adjuvant or two doses of 35 mcg of inactivated SARS-CoV-2 virus with alum adjuvant

DRUG

Placebo

0.5ml Saline (0.9%)

Sponsors & Collaborators

  • Veterinary Serum & Vaccine Research Institute (VSVRI), Egypt

    collaborator UNKNOWN

  • The Supreme Council of University Hospitals, Egypt

    collaborator UNKNOWN

  • Ministry of Higher Education and Scientific Research, Egypt

    collaborator UNKNOWN

  • Eva Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-06
Primary Completion
2022-10-31
Completion
2023-06-30

Countries

  • Egypt

Study Locations

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Entities

Drugs
Diseases

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 NCT05218070 on ClinicalTrials.gov