NCT05218070

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

Safety and Immunogenicity Study of EgyVax Vaccine Candidate for Prophylaxis of Severe Acute Respiratory Syndrome (SARS) - Coronavirus 2 (CoV-2) Infection (COVID-19)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Eva Pharma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Detailed description

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

Conditions

• COVID-19

Interventions

Type	Name	Description
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%)

Timeline

• Start date: 2022-02-06
• Primary completion: 2022-10-01
• Completion: 2023-06-01
• First posted: 2022-02-01
• Last updated: 2022-02-23

Locations

1 site across 1 country: Egypt