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Reactogenicity, Safety and Immunogenicity 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: NCT04530357
Recruitment Status : Completed
First Posted : August 28, 2020
Last Update Posted : May 4, 2021
Sponsor:
Collaborator:
National Scientific Center for Phthisiopulmonology of the Republic of Kazakhstan
Information provided by (Responsible Party):
Research Institute for Biological Safety Problems

Tracking Information
First Submitted Date  ICMJE August 26, 2020
First Posted Date  ICMJE August 28, 2020
Last Update Posted Date May 4, 2021
Actual Study Start Date  ICMJE September 19, 2020
Actual Primary Completion Date November 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2021)
  • 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
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: August 27, 2020)
  • 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
  • The proportion of volunteers with increased levels of the immune response in terms of specific neutralizing antibody titers in ELISA following the vaccination, compared with a placebo [ Time Frame: at days 0, 21, 27, 42, 180 ]
    The proportion of volunteers with increased levels of the immune response in terms of specific neutralizing antibody titers in ELISA greater than ≥ 4 times 21 days following the second vaccination and 180 days following the first vaccination, compared with a placebo.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2021)
  • 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.
  • Cell-mediated immune profile [ Time Frame: at days 0, 7, 21, 27, 42 ]
    Cell-mediated immune profile - Cytokine profiles in placebo and vaccine groups
Original Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2020)
  • Incidence of serious adverse events during the study [ Time Frame: throughout the study, an average of 180 days ]
    Incidence of serious adverse events during the study.
  • Cell-mediated immune profile [ Time Frame: at days 0, 7, 21, 27, 42 ]
    Cell-mediated immune profile
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reactogenicity, Safety and Immunogenicity of QazCovid-in® COVID-19 Vaccine
Official Title  ICMJE 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
Brief Summary 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
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
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® - COVID-19 inactivated vaccine
    QazCovid-in® (inactivated) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan
  • Other: Placebo
    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)
Study Arms  ICMJE
  • 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
    Intervention: Biological: QazCovid-in® - COVID-19 inactivated vaccine
  • 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
    Intervention: Other: Placebo
  • 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
    Intervention: Biological: QazCovid-in® - COVID-19 inactivated vaccine
  • 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
    Intervention: Biological: QazCovid-in® - COVID-19 inactivated vaccine
  • 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
    Intervention: Biological: QazCovid-in® - COVID-19 inactivated vaccine
  • 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
    Intervention: Biological: QazCovid-in® - COVID-19 inactivated vaccine
Publications * Zakarya K, Kutumbetov L, Orynbayev M, Abduraimov Y, Sultankulova K, Kassenov M, Sarsenbayeva G, Kulmagambetov I, Davlyatshin T, Sergeeva M, Stukova M, Khairullin B. Safety and immunogenicity of a QazCovid-in® inactivated whole-virion vaccine against COVID-19 in healthy adults: A single-centre, randomised, single-blind, placebo-controlled phase 1 and an open-label phase 2 clinical trials with a 6 months follow-up in Kazakhstan. EClinicalMedicine. 2021 Sep;39:101078. doi: 10.1016/j.eclinm.2021.101078. Epub 2021 Aug 14.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: August 27, 2020)
244
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 25, 2021
Actual Primary Completion Date November 25, 2020   (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 18-50 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (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 NCT04530357
Other Study ID Numbers  ICMJE QAZCOV-I/II-01/2020
Has Data Monitoring Committee Yes
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 National Scientific Center for Phthisiopulmonology of the Republic of Kazakhstan
Investigators  ICMJE
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
PRS Account Research Institute for Biological Safety Problems
Verification Date February 2021

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