Randomized, blind, placebo-controlled phase- i study and randomized, open phase phase-ii study of QAZCOVID-IN®- COVID-19 inactivated vaccine in healthy adult volunteers from 18 years old and elder
Purpose of the Phase-I clinical study Evaluation of the safety,acceptability and immunogenicity of QazCovid-in®-COVID-19 inactivated vaccine when administeredtwice in healthy volunteers aged 18-50 years. Purpose of the Phase-II clinical study Evaluation of the safety and immunogenicity of QazCovid-in® - COVID-19 inactivated vaccine with single and dual use in healthy volunteers aged 18 and above.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
244
QazCovid-in® (inactivated) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan
Placebo (sodium chloride bufus, solvent for the preparation of dosage forms for injection 0.9%) The use of placebo: intramuscularly, twice, spaced 21 days apart, at a dose of 0.5 ml (22 volunteers)
Research Institute for Biological Safety Problems Committee of Science of the Ministry of Education and Science of the Republic of Kazakhstan
Gvardeyskiy, Zhambyl, Kazakhstan
Frequency of adverse events up to seven days after immunization
Frequency of adverse reaction in the seven days following each immunization per age group
Time frame: Seven days after each immunization
Frequency of adverse events up to 21 days after immunization
Frequency of adverse reaction in the 21 days following each immunization per age group
Time frame: 21 days after each immunization
The proportion of volunteers with increased levels of the immune response of specific neutralizing antibody titers in ELISA following the vaccination, compared with a placebo
The proportion of volunteers with increased levels of the immune response of specific neutralizing antibody titers in ELISA greater than ≥ 4 times 21 days following the second vaccination compared with a placebo.
Time frame: at days 0, 21, 27, 42
Changing of virus-neutralizing antibodies to SARS-CoV-2 virus in blood serum samples
Determination of virus neutralizing antibody titer to SARS-CoV-2 virus in blood serum samples
Time frame: at days 0, 21, 27, 42
Incidence of serious adverse events during the study
Incidence of serious adverse events during the study.
Time frame: throughout the study, an average of 42 days
Cell-mediated immune profile
Cell-mediated immune profile - Cytokine profiles in placebo and vaccine groups
Time frame: at days 0, 7, 21, 27, 42
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