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

COVID-19 Clinical Trial

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

Status Recruiting

Clinical Trial 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).

Clinical Trial 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 ;

Related Conditions & MeSH terms

• COVID-19

• NCT number: NCT05218070
• Study type: Interventional
• Source: Eva Pharma
• Contact: Sameera Ezzat, MD
• Phone: +201001551576
• Email: samira.ezzat@evapharma.com
• Status: Recruiting
• Phase: Phase 1
• Start date: February 6, 2022
• Completion date: June 2023