Covid19, SARS-CoV Infection, Vaccine Adverse Reaction
Conditions
Keywords
vaccine, I/II phase, safety, immunogenicity, QazCovid-in®
Brief summary
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
Detailed description
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.
Interventions
BIOLOGICALQazCovid-in® - COVID-19 inactivated vaccine
QazCovid-in® (inactivated) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan
OTHERPlacebo
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)
Sponsors
National Scientific Center for Phthisiopulmonology of the Republic of Kazakhstan
Research Institute for Biological Safety Problems
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of adverse events up to seven days after immunization | Seven days after each immunization | Frequency of adverse reaction in the seven days following each immunization per age group |
| Frequency of adverse events up to 21 days after immunization | 21 days after each immunization | Frequency of adverse reaction in the 21 days following each immunization per age group |
| 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 | at days 0, 21, 27, 42 | 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. |
| Changing of virus-neutralizing antibodies to SARS-CoV-2 virus in blood serum samples | at days 0, 21, 27, 42 | Determination of virus neutralizing antibody titer to SARS-CoV-2 virus in blood serum samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of serious adverse events during the study | throughout the study, an average of 42 days | Incidence of serious adverse events during the study. |
| Cell-mediated immune profile | at days 0, 7, 21, 27, 42 | Cell-mediated immune profile - Cytokine profiles in placebo and vaccine groups |
Countries
Kazakhstan
Outcome results
None listed