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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
44
Vaccination on Day 0 and Day 21
Placebo Vaccination on Day 0 and Day 21
Erciyes University Hakan Çetinsaya Iyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP)
Kayseri, Turkey (Türkiye)
To assess the safety and tolerability of the COVID-19 vaccine
The number and proportion of subjects with adverse events observed until Day 43 post 1st vaccination are declared to be primary target variables.
Time frame: 43 days
Serum IgG antibody Levels
Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s).
Time frame: 12 months
Neutralizing Antibodies Levels
Serum Neutralizing antibody levels.
Time frame: 12 months
TNF-alpha Levels
Serum TNF-alpha levels.
Time frame: 12 months
Interferon Levels
Serum IFN-γ levels.
Time frame: 12 months
Interleukine Levels
Serum IL-2, -4, -5, -6 levels.
Time frame: 12 months
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