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.
Biological: QazCovid-in® - COVID-19 inactivated vaccine
QazCovid-in® (inactivated) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan
Other: Placebo
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)
Inclusion Criteria:
- Availability of signed and dated informed consent of the volunteer to participate in
the study.
- Healthy male and female volunteers aged 18-50 and 50 and above.
- Ability and voluntary desire to independently keep records in the Self-Observation
Diary, as well as to carry out all the repeated visits provided for in the study for
control medical observation.
- The voluntary desire of females to use methods of reliable contraception throughout
the entire period of their participation in the study.
- Negative results for IgM and IgG antibodies to SARS-CoV-2.
- Absence of COVID-19 diagnosis in history.
- Absence in the last 14 days of close contact with persons suspected of being infected
with SARS-CoV-2, or persons whose diagnosis of COVID-19 has been confirmed with
laboratory.
- Negative test results for human immunodeficiency virus (HIV), hepatitis B and
hepatitis C.
Exclusion Criteria:
- Aggravated allergic history, drug intolerance, including hypersensitivity to any of
the components of the study drug, as well as a history of serious adverse events
during vaccine administration (such as allergic reactions, respiratory failure,
angioedema, abdominal pain).
- Acute illness with fever (body temperature ≥37.1°C) at the time of
screening/randomization.
- Chronic alcohol and/or drug use in history.
- Clinically significant deviations from normal values during laboratory and/or imaging
at screening.
- Women with a positive urine pregnancy test.
- Simultaneous treatment with immunosuppressive drugs, including corticosteroids (2
weeks) 4 weeks prior to study drug administration.
- Acute or chronic clinically significant lesions of the lungs, cardiovascular system,
gastrointestinal tract, liver, blood system, skin, endocrine, neurological and
psychiatric diseases or impaired renal function (asthma, diabetes, thyroid disease,
arrhythmia, myocardial infarction, severe hypertension not controlled by drugs, etc.),
identified based on medical history, physical examination or clinical laboratory tests
that, according to the researcher, may affect the study result.
- Disruption of platelets or other blood clotting disorders, which may cause
contraindications to intramuscular administration.
- Leukemia or neoplasm in history.
- Persons with autoimmune diseases.
- Volunteers who received antiviral drugs, immunoglobulin's or blood transfusions or any
other investigational drug within 4 weeks prior to study drug administration;
- Volunteers who received anti-inflammatory drugs 2 days before study drug
administration;
- Participation in any other clinical research within the last 3 months.
- Volunteers with a concern that they will not comply with the study requirements, or
persons with severe physical or mental disabilities that may affect the completion of
the study.
- Voluntary refusal to study.
Research Institute for Biological Safety Problems Committee of Science of the Ministry of Education and Science of the Republic of Kazakhstan
Gvardeyskiy, Jambul, Kazakhstan