NCT04691947

Safety and Immunogenicity of Two Different Strengths of the Inactivated COVID-19 Vaccine ERUCOV-VAC

Phase 1 Study for the Determination of Safety and Immunogenicity of Two Different Strengths of the Inactivated COVID-19 Vaccine ERUCOV-VAC, Given Twice Intramuscularly to Healthy Volunteers, in a Placebo Controlled Study Design.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Health Institutes of Turkey · Other Government
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective is to determine the safety and immunogenicity of two different strengths (3 µg and 6 µg) of an inactivated COVID 19 Vaccine compared to placebo so that to demonstrate the safety and efficacy in prophylaxis of COVID-19.

Detailed description

This is a double-blind, double dose, parallel, randomized vaccination study. Each subject will receive in random order a double intramuscular dose of ERUCOV-VAC 3 µg/0.5 ml Vaccine, ERUCOV-VAC 6 µg/0.5 ml Vaccine or 0.5 ml of placebo Vaccine according to a sequence determined by randomization, on Day 0 (1st vaccination) and Day 21 (2nd vaccination).In total 34 healthy subjects of both genders will be monitored for one year in total, after Day 43 the study will be unblinded and the volunteers who took placebo vaccine will be released from the study. The most important evaluation will be performed on Day 43 after the first vaccine dose.

Conditions

• COVID-19 Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	ERUCOV-VAC	Vaccination on Day 0 and Day 21
OTHER	Placebo Vaccine	Placebo Vaccination on Day 0 and Day 21

Timeline

• Start date: 2020-11-05
• Primary completion: 2021-11-18
• Completion: 2021-11-18
• First posted: 2020-12-31
• Last updated: 2023-02-14

Locations

1 site across 1 country: Turkey (Türkiye)