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Reactogenicity, Safety and Immunogenicity of QazCoVac-P COVID-19 Vaccine | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Reactogenicity, Safety and Immunogenicity of QazCoVac-P COVID-19 Vaccine

Randomized, Blind, Placebo-controlled Phase- I Study and Randomized, Open Phase Phase-II Study of QazCoVac-P - COVID-19 Subunit Vaccine in Healthy Adult Volunteers From 18 Years Old and Elder

NCT04930003•Research Institute for Biological Safety Problems

View on ClinicalTrials.gov

Summary

Randomized, Blind, Placebo-controlled Phase- I Study and Randomized, Open Phase Phase-II Study of QazCoVac-P - COVID-19 Subunit 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 QazCoVac-P - COVID-19 Subunit vaccine when administered twice in healthy volunteers aged 18-50 years. Purpose of the Phase-II clinical study Evaluation of the safety and immunogenicity of QazCoVac-P - COVID-19 Subunit vaccine with single and dual use in healthy volunteers aged 18 and above

Eligibility

Age

18 - 100 years

Sex

ALL

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 SelfObservation 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.
•Negative PCR results for coronavirus SARS-CoV-2
+1 more criteria

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 a 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.
+9 more criteria

Locations (1)

Research Institute for Biological Safety Problems Committee of Science of the Ministry of Education and Science of the Republic of Kazakhstan

Gvardeyskiy, Jambul, Kazakhstan

Key Dates

Start Date

June 15, 2021

Primary Completion Date

December 15, 2021

Completion Date

December 15, 2021

Last Updated

December 7, 2023

Enrollment

244

ACTUAL participants

Conditions

Covid19SARS-CoV InfectionVaccine Adverse Reaction

Interventions

QazCoVac-P -COVID-19 Subunit Vaccine

BIOLOGICAL

Placebo

OTHER

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 7, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Reactogenicity, Safety and Immunogenicity of QazCoVac-P COVID-19 Vaccine

Inclusion Criteria

Exclusion Criteria

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