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Safety and Immunogenicity Study of EgyVax Vaccine Candidate for Prophylaxis of Severe Acute Respiratory Syndrome (SARS) - Coronavirus 2 (CoV-2) Infection (COVID-19)
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).
Study subjects will receive one dose of study intervention as assigned at each vaccination visit (Visits 1 and 4) via intramuscular (IM) injection in the upper arm approximately 14 days apart. Study interventions should be administered into the deltoid muscle, preferably of the nondominant arm . Each subject will be assigned to receive either: * 35 mcg dose for both vaccinations at day 0 and day 14 (low dose, 15 subjects) * 70 mcg dose for both vaccinations at day 0 and day 14 (high dose, 15 subjects) * Placebo for both injections at day 0 and day 14 (Placebo, 15 subjects) For easier reference, refer to the below definitions of each study group: * Cohort 1: first three subjects of the low dose vaccination group plus two subjects from the control group * Cohort 2: second three subjects of the low dose vaccination group plus one subject from the control group * Cohort 3: remaining nine subjects of the low dose vaccination group plus two subjects from the control group * Cohort 4: first three subjects of the high dose vaccination group plus two subjects from the control group. * Cohort 5: second three subjects of the high dose vaccination group plus one subject from the control group * Cohort 6: remaining nine subjects of the high dose vaccination group plus two subjects from the control group Step 1 (Day 0): Cohort 1 will receive their initial dose of vaccine. Step 2 (Day 7): After 7 days from step 1, Cohort 2 will receive their initial dose of vaccine. Step 3 (Day 14): After 7 days from step 2; Cohort 1 will receive their second dose of vaccine, and Cohort 3 \& 4 will randomly receive their initial dose of vaccine. Step 4 (Day 21): After 7 days from step 3, Cohort 2 will receive their second dose of vaccine, and Cohort 5 will receive their initial dose of vaccine Step 5 (Day 28): After 7 days from step 4, Cohort 3 \& 4 will receive their second dose of vaccine, and Cohort 6 will receive their initial dose of vaccine Step 6 (Day 35): After 7 days from step 5, Cohort 5 will receive their second dose of vaccine Step 7 (Day 42): After 7 days from step 6, Cohort 6 will receive their second dose of vaccine. The Data Monitoring Committee (DMC) will periodically review trial data including safety data. Subjects will also be asked to provide blood samples at specified time points, which investigators will test in the laboratory to detect and measure the immune response to the vaccine candidate
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
Yes
Cairo University Hospitals (Al-Manial Specialized University Hospital)
Cairo, Egypt
Start Date
February 6, 2022
Primary Completion Date
October 1, 2022
Completion Date
June 1, 2023
Last Updated
February 23, 2022
45
ESTIMATED participants
EgyVax Vaccine Candidate
DRUG
Placebo
DRUG
Lead Sponsor
Eva Pharma
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06631287