- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04530357
Reactogenicity, Safety and Immunogenicity of QazCovid-in® COVID-19 Vaccine
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Jambul
-
Gvardeyskiy, Jambul, Kazakhstan, 080409
- Research Institute for Biological Safety Problems Committee of Science of the Ministry of Education and Science of the Republic of Kazakhstan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phase 1 Adult-vaccine (A Sample, blind study)
Group 1 (phase 1): 22 volunteers aged 18-50 years who will be the QazCovid-in® - COVID-19 twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml
|
QazCovid-in® (inactivated) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan
|
Placebo Comparator: Phase 1 Adult-Placebo (A Sample, blind study)
Group 2 (phase 1): 22 volunteers aged 18-50 years who will be the Placebo twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml
|
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)
|
Experimental: Phase 2 Adult-Vaccine, twice vaccination (An Open study)
Group 3 (phase 2): 50 volunteers aged 18-50 years who will be the QazCovid-in® - COVID-19 twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml
|
QazCovid-in® (inactivated) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan
|
Experimental: Phase 2 Elderly-Vaccine, twice vaccination (An Open study)
Group 4 (phase 2): 50 volunteers from 18 years old and elder who will be the QazCovid-in® - COVID-19 twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml
|
QazCovid-in® (inactivated) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan
|
Experimental: Phase 2 Adult-Vaccine, single vaccination (An Open study)
Group 5 (phase 2): 50 volunteers from 18 years old and elder who will be the QazCovid-in® - COVID-19 single vaccination, intramuscularly, at a dose of 0.5 ml volunteers from 18 years old and elder
|
QazCovid-in® (inactivated) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan
|
Experimental: Phase 2 Elderly-Vaccine, single vaccination (An Open study)
Group 6 (phase 2): 50 vvolunteers from 18 years old and elder who will be the QazCovid-in® - COVID-19 single vaccination, intramuscularly, at a dose of 0.5 ml
|
QazCovid-in® (inactivated) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of adverse events up to seven days after immunization
Time Frame: Seven days after each immunization
|
Frequency of adverse reaction in the seven days following each immunization per age group
|
Seven days after each immunization
|
Frequency of adverse events up to 21 days after immunization
Time Frame: 21 days after each immunization
|
Frequency of adverse reaction in the 21 days following each immunization per age group
|
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
Time Frame: 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.
|
at days 0, 21, 27, 42
|
Changing of virus-neutralizing antibodies to SARS-CoV-2 virus in blood serum samples
Time Frame: at days 0, 21, 27, 42
|
Determination of virus neutralizing antibody titer to SARS-CoV-2 virus in blood serum samples
|
at days 0, 21, 27, 42
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of serious adverse events during the study
Time Frame: throughout the study, an average of 42 days
|
Incidence of serious adverse events during the study.
|
throughout the study, an average of 42 days
|
Cell-mediated immune profile
Time Frame: at days 0, 7, 21, 27, 42
|
Cell-mediated immune profile - Cytokine profiles in placebo and vaccine groups
|
at days 0, 7, 21, 27, 42
|
Collaborators and Investigators
Investigators
- Study Director: Berik Khairullin, PhD, Research Institute for Biological Safety Problems
- Study Chair: Kunsulu Zakarya, PhD, Research Institute for Biological Safety Problems
- Principal Investigator: Ilyas Kulmagambetov, PhD, Centre for Clinical Medicine and Research
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QAZCOV-I/II-01/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Covid19
-
Anavasi DiagnosticsNot yet recruiting
-
Ain Shams UniversityRecruiting
-
Israel Institute for Biological Research (IIBR)Completed
-
Colgate PalmoliveCompleted
-
Christian von BuchwaldCompleted
-
Luye Pharma Group Ltd.Shandong Boan Biotechnology Co., LtdActive, not recruiting
-
University of ZurichLabor Speiz; Swiss Armed Forces; Universitätsspital ZürichEnrolling by invitation
-
Alexandria UniversityCompleted
Clinical Trials on QazCovid-in® - COVID-19 inactivated vaccine
-
Research Institute for Biological Safety ProblemsCity polyclinic No. 4 of the of Almaty Ministry of Healthcare of the Republic... and other collaboratorsCompletedCovid19 | Vaccine Adverse Reaction | SARS-CoV InfectionKazakhstan
-
Sinovac Research and Development Co., Ltd.Active, not recruiting
-
Sinovac Biotech (Colombia) S.A.S.Sinovac Life Sciences Co., Ltd.Not yet recruiting
-
China National Biotec Group Company LimitedThe University of Hong Kong; Beijing Institute of Biological Products Co Ltd.; Wuhan Institute of Biological Products Co., LtdActive, not recruiting
-
China National Biotec Group Company LimitedWuhan Institute of Biological Products Co., Ltd; Hubei Provincial Center for...RecruitingHIV Infections | COVID-19China
-
China National Biotec Group Company LimitedBeijing Institute of Biological Products Co Ltd.; Zhejiang Provincial Center...Not yet recruitingHIV Infections | COVID-19China
-
China National Biotec Group Company LimitedBeijing Institute of Biological Products Co Ltd.; Zhejiang Provincial Center...RecruitingCOVID-19 | COPD | Chronic BronchitisChina
-
China National Biotec Group Company LimitedWuhan Institute of Biological Products Co., Ltd; Hubei Provincial Center for...RecruitingCOVID-19 | Copd | Chronic BronchitisChina
-
China National Biotec Group Company LimitedBeijing Institute of Biological Products Co Ltd.; Zhejiang Provincial Center...RecruitingHIV Infections | COVID-19China
-
China National Biotec Group Company LimitedBeijing Institute of Biological Products Co Ltd.; Zhejiang Provincial Center...Not yet recruitingCOVID-19 | COPD | Chronic BronchitisChina