Immunogenicity, Efficacy and Safety of QazCovid-in® COVID-19 Vaccine
NCT ID: NCT04691908
Last Updated: 2023-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
3000 participants
INTERVENTIONAL
2020-12-25
2021-07-11
Brief Summary
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Detailed Description
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To evaluate the immunogenicity of the QazCovid-in® vaccine inactivated against COVID-19 versus placebo.
Evaluate vaccine efficacy.
Evaluate the safety of vaccine versus placebo.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Phase III Adult-vaccine (A Sample, blind study)
Group 1 (phase III): 2400 volunteers from 18 years old and elder who will be the QazCovid-in® twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml
QazCovid-in®-vaccine against COVID-19
QazCovid-in® (inactivated) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan
Phase III Adult-Placebo (A Sample, blind study)
Group 1 (phase III): 600 volunteers from 18 years old and elder who will be the Placebo twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml
Placebo
Placebo (sodium chloride buffs, solvent for the preparation of dosage forms for injection 0.9%)
Interventions
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QazCovid-in®-vaccine against COVID-19
QazCovid-in® (inactivated) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan
Placebo
Placebo (sodium chloride buffs, solvent for the preparation of dosage forms for injection 0.9%)
Eligibility Criteria
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Inclusion Criteria
Healthy male and female volunteers aged 18 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.
Exclusion Criteria
Acute illness with a fever (body temperature ≥37.1 ° C) at the time of screening.
History of chronic alcohol abuse and/or drug use. Positive results for antibodies IgM, IgG to SARS-CoV-2 Women with a positive urine pregnancy test. Simultaneous treatment with immunosuppressive drugs, incl. 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, heart attack myocardium, severe hypertension not controlled by drugs, etc.), identified based on the data of the medical history, physical examination, which, according to the researcher, may affect the study result.
History of platelet disorder or other blood clotting disorders that may cause contraindications to intramuscular administration.
History of leukemia or neoplasm. Persons with autoimmune diseases. A history of Guillain-Barré syndrome or other neuroimmunological diseases. Subjects who received antiviral drugs, immunoglobulins or blood transfusions or any other investigational drug within 4 weeks prior to study drug administration; Subjects who received anti-inflammatory drugs 2 days prior to study drug administration; Participation in any other clinical research within the last 6 months. Subjects with regard to whom there is a concern that they will not comply with the requirements of the study, or persons with severe physical or mental disabilities that may affect the completion of the study.
Voluntary refusal to study. Vulnerable research subjects.
18 Years
100 Years
ALL
Yes
Sponsors
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City polyclinic No. 4 of the of Almaty Ministry of Healthcare of the Republic of Kazakhstan
UNKNOWN
Clinic of the International Institute of Postgraduate Education Ministry of Healthcare of the Republic of Kazakhstan
UNKNOWN
City Multidisciplinary Hospital of Zhambyl Region Ministry of Healthcare of the Republic of Kazakhstan
UNKNOWN
Research Institute for Biological Safety Problems
OTHER_GOV
Responsible Party
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Principal Investigators
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Berik Khairullin, PhD
Role: STUDY_DIRECTOR
Research Institute for Biological Safety Problems Committee of Science of the Ministry of Education and Science of the Republic of Kazakhstan
Kunsulu Zakarya, PhD
Role: STUDY_CHAIR
Research Institute for Biological Safety Problems Committee of Science of the Ministry of Education and Science of the Republic of Kazakhstan
IIlyas Kulmagambetov, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre for Clinical Medicine and Research
Locations
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Research Institute for Biological Safety Problems Committee of Science of the Ministry of Education and Science of the Republic of Kazakhstan
Gvardeyskiy, Jambul, Kazakhstan
Countries
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References
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Khairullin B, Zakarya K, Orynbayev M, Abduraimov Y, Kassenov M, Sarsenbayeva G, Sultankulova K, Chervyakova O, Myrzakhmetova B, Nakhanov A, Nurpeisova A, Zhugunissov K, Assanzhanova N, Nurabayev S, Kerimbayev A, Yershebulov Z, Burashev Y, Kulmagambetov I, Davlyatshin T, Sergeeva M, Buzitskaya Z, Stukova M, Kutumbetov L. Efficacy and safety of an inactivated whole-virion vaccine against COVID-19, QazCovid-in(R), in healthy adults: A multicentre, randomised, single-blind, placebo-controlled phase 3 clinical trial with a 6-month follow-up. EClinicalMedicine. 2022 Jun 25;50:101526. doi: 10.1016/j.eclinm.2022.101526. eCollection 2022 Aug.
Other Identifiers
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QAZCOV-III-01/2020
Identifier Type: -
Identifier Source: org_study_id