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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 : Active, not recruiting
First Posted : December 31, 2020
Last Update Posted : February 24, 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

Tracking Information
First Submitted Date  ICMJE December 21, 2020
First Posted Date  ICMJE December 31, 2020
Last Update Posted Date February 24, 2021
Actual Study Start Date  ICMJE December 25, 2020
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 29, 2020)
  • 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)
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2020)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity, Efficacy and Safety of QazCovid-in® COVID-19 Vaccine
Official Title  ICMJE 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
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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Covid19
  • SARS-CoV Infection
  • Vaccine Adverse Reaction
Intervention  ICMJE
  • Biological: QazCovid-in®-vaccine against COVID-19
    QazCovid-in® (inactivated) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan
  • Other: Placebo
    Placebo (sodium chloride buffs, solvent for the preparation of dosage forms for injection 0.9%)
Study Arms  ICMJE
  • 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
    Intervention: Biological: QazCovid-in®-vaccine against COVID-19
  • 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
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 29, 2020)
3000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 30, 2021
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kazakhstan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04691908
Other Study ID Numbers  ICMJE QAZCOV-III-01/2020
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Research Institute for Biological Safety Problems
Study Sponsor  ICMJE Research Institute for Biological Safety Problems
Collaborators  ICMJE
  • 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  ICMJE
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
PRS Account Research Institute for Biological Safety Problems
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP