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Immunogenicity, Efficacy and Safety of QazCovid-in® COVID-19 Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04691908
Recruitment Status : Completed
First Posted : December 31, 2020
Last Update Posted : July 26, 2021
Sponsor:
Collaborators:
City polyclinic No. 4 of the UZO of Almaty
Clinic of the International Institute of Postgraduate Education
City Multidisciplinary Hospital of the Health Department of the Akimat of Zhambyl Region
Information provided by (Responsible Party):
Research Institute for Biological Safety Problems

Brief Summary:
Multicenter, randomized, blind, placebo-controlled clinical study of III phases on the assessment of preventive efficiency, safety and immunogenicity QazCovid-in®-vaccine against COVID-19 in healthy adult volunteers

Condition or disease Intervention/treatment Phase
Covid19 SARS-CoV Infection Vaccine Adverse Reaction Biological: QazCovid-in®-vaccine against COVID-19 Other: Placebo Phase 3

Detailed Description:

The main objective of the study is to prove the superiority of the QazCovid-in®-vaccine inactivated against COVID-19 in comparison with placebo in terms of seroconversion (the proportion of persons with a fourfold or higher increase in antibody titers to SARS-CoV-2) on the 21st, 42nd day, 90th and 180th days after vaccination.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Multicenter, Randomized, Blind, Placebo-controlled Clinical Study of III Phase on Assessment of Preventive Efficiency, Safety and Immunogenicity QazCovid-in®-Vaccine Against COVID-19 in Healthy Adult Volunteers
Actual Study Start Date : December 25, 2020
Actual Primary Completion Date : April 26, 2021
Actual Study Completion Date : July 11, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
Biological: QazCovid-in®-vaccine against COVID-19
QazCovid-in® (inactivated) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan

Placebo Comparator: 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
Other: Placebo
Placebo (sodium chloride buffs, solvent for the preparation of dosage forms for injection 0.9%)




Primary Outcome Measures :
  1. Terms of seroconversion (the proportion of persons with a fourfold or higher change in antibody titers to SARS-CoV-2) [ Time Frame: at days 0, 21, 42, 90, 180 ]
    The main objective of the study is to prove the superiority of the QazCovid-in®-vaccine inactivated against COVID-19 in comparison with placebo in terms of seroconversion (the proportion of persons with a fourfold or higher change in antibody titers to SARS-CoV-2)

  2. To evaluate the immunogenicity of the QazCovid-in® vaccine inactivated against COVID-19 versus placebo [ Time Frame: at days 0, 21, 42, 90, 180 ]
    The geometric mean titer of serum antibodies ELISA to SARS-CoV-2 after vaccination. The multiplicity of the change in the geometric mean titer of serum antibodies to SARS-CoV-2 after vaccination.

  3. Frequency of confirmed cases of COVID-19 [ Time Frame: through study completion, an average of 6 months ]
    The presence of clinical manifestations and a positive laboratory test for SARS-CoV-2 virus RNA within 6 months after vaccination


Secondary Outcome Measures :
  1. Changing of antigen-specific cellular immunity level [ Time Frame: at days 0, 90, 180 ]
    Determination of the level of production of intracellular cytokines by antigen-activated T-lymphocytes

  2. 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

  3. 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

  4. Incidence of serious adverse events during the study [ Time Frame: throughout the study, an average of 6 months ]
    Incidence of serious adverse events during the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Availability of signed and dated informed consent of the volunteer to participate in the study.

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:

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.

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04691908


Locations
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Kazakhstan
Research Institute for Biological Safety Problems Committee of Science of the Ministry of Education and Science of the Republic of Kazakhstan
Gvardeyskiy, Jambul, Kazakhstan, 080409
Sponsors and Collaborators
Research Institute for Biological Safety Problems
City polyclinic No. 4 of the UZO of Almaty
Clinic of the International Institute of Postgraduate Education
City Multidisciplinary Hospital of the Health Department of the Akimat of Zhambyl Region
Investigators
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Study Director: Berik Khairullin, PhD Research Institute for Biological Safety Problems Committee of Science of the Ministry of Education and Science of the Republic of Kazakhstan
Study Chair: Kunsulu Zakarya, PhD Research Institute for Biological Safety Problems Committee of Science of the Ministry of Education and Science of the Republic of Kazakhstan
Principal Investigator: IIlyas Kulmagambetov, PhD Centre for Clinical Medicine and Research
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Responsible Party: Research Institute for Biological Safety Problems
ClinicalTrials.gov Identifier: NCT04691908    
Other Study ID Numbers: QAZCOV-III-01/2020
First Posted: December 31, 2020    Key Record Dates
Last Update Posted: July 26, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Research Institute for Biological Safety Problems:
QazCovid-in®, vaccine, III phase, efficiency, safety, immunogenicity
Additional relevant MeSH terms:
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COVID-19
Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases