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出境医 / 临床实验 / Reactogenicity, Safety and Immunogenicity of QazCoVac-P COVID-19 Vaccine

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

Study Description
Brief 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

Condition or disease Intervention/treatment Phase
Covid19 SARS-CoV Infection Vaccine Adverse Reaction Biological: QazCoVac-P -COVID-19 Subunit Vaccine Other: Placebo Phase 1 Phase 2

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : June 15, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Experimental: Phase 1 Adult-vaccine (A Sample, blind study)
Group 1 (phase 1): 22 volunteers aged 18-50 years who will be the QazCoVac-P - COVID-19 twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml
 Biological: QazCoVac-P -COVID-19 Subunit Vaccine
QazCoVac-P (Subunit) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan
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
 Other: Placebo
The use of placebo: intramuscularly, twice, spaced 21 days apart, at a dose of 0.5 ml (22 volunteers)
Experimental: Phase 2 Adult-Vaccine, twice vaccination (An Open study)
Group 3 (phase 2): 50 volunteers aged 18-50 years who will be the QazCoVac-P - COVID-19 twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml
 Biological: QazCoVac-P -COVID-19 Subunit Vaccine
QazCoVac-P (Subunit) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan
Experimental: Phase 2 Elderly-Vaccine, twice vaccination (An Open study)
Group 4 (phase 2): 50 volunteers from 50 years old and elder who will be the QazCoVac-P - COVID-19 twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml
 Biological: QazCoVac-P -COVID-19 Subunit Vaccine
QazCoVac-P (Subunit) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan
Experimental: Phase 2 Adult-Vaccine, single vaccination (An Open study)
Group 5 (phase 2): 50 volunteers aged 18-50 years who will be the QazCoVac-P - COVID-19 single vaccination, intramuscularly, at a dose of 0.5 ml
 Biological: QazCoVac-P -COVID-19 Subunit Vaccine
QazCoVac-P (Subunit) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan
Experimental: Phase 2 Elderly-Vaccine, single vaccination (An Open study)
Group 6 (phase 2): 50 volunteers from 50 years old and elder who will be the QazCoVac-P - COVID-19 single vaccination, intramuscularly, at a dose of 0.5 ml
 Biological: QazCoVac-P -COVID-19 Subunit Vaccine
QazCoVac-P (Subunit) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan
Outcome Measures
Primary Outcome Measures :
  1. 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

  2. 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

  3. 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, 90, 180 ]
    The proportion of volunteers with changed levels of the immune response of specific neutralizing antibody titers in ELISA greater than ≥ 4 times compared with a placebo.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Cell-mediated immune profile [ Time Frame: at days 0, 7, 21, 42 ]
    Cellular immunity will be assessed by reliable (more than 2 standard deviations from the mean pre-vaccination level) increases in post-vaccination level (%) of CD4 + and CD8 + T-cells.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (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 18-50 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
  • According to the results of a chest x-ray, there is no pathological process in the lungs.

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.
  • 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;
  • Negative PCR results for coronavirus SARS-CoV-2;
  • According to the results of a chest x-ray, there is no pathological process in the lungs;
  • Voluntary refusal to study;
  • Vulnerable Volunteers of research.
Contacts and Locations

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
Investigators
Layout table for investigator information
Study Chair: Kunsulu Zakarya, Ph.D. Research Institute for Biological Safety Problems
Tracking Information
First Submitted Date  ICMJE February 22, 2021
First Posted Date  ICMJE June 18, 2021
Last Update Posted Date July 29, 2021
Actual Study Start Date  ICMJE June 15, 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 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, 90, 180 ]
    The proportion of volunteers with changed levels of the immune response of specific neutralizing antibody titers in ELISA greater than ≥ 4 times compared with a placebo.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 15, 2021) 		Cell-mediated immune profile [ Time Frame: at days 0, 7, 21, 42 ]
Cellular immunity will be assessed by reliable (more than 2 standard deviations from the mean pre-vaccination level) increases in post-vaccination level (%) of CD4 + and CD8 + T-cells.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Reactogenicity, Safety and Immunogenicity of QazCoVac-P COVID-19 Vaccine
Official Title  ICMJE 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
Brief 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Covid19
  • SARS-CoV Infection
  • Vaccine Adverse Reaction
Intervention  ICMJE
  • Biological: QazCoVac-P -COVID-19 Subunit Vaccine
    QazCoVac-P (Subunit) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan
  • Other: Placebo
    The use of placebo: intramuscularly, twice, spaced 21 days apart, at a dose of 0.5 ml (22 volunteers)
Study Arms  ICMJE
  • Experimental: Experimental: Phase 1 Adult-vaccine (A Sample, blind study)
    Group 1 (phase 1): 22 volunteers aged 18-50 years who will be the QazCoVac-P - COVID-19 twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml
    Intervention: Biological: QazCoVac-P -COVID-19 Subunit 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 QazCoVac-P - COVID-19 twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml
    Intervention: Biological: QazCoVac-P -COVID-19 Subunit Vaccine
  • Experimental: Phase 2 Elderly-Vaccine, twice vaccination (An Open study)
    Group 4 (phase 2): 50 volunteers from 50 years old and elder who will be the QazCoVac-P - COVID-19 twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml
    Intervention: Biological: QazCoVac-P -COVID-19 Subunit Vaccine
  • Experimental: Phase 2 Adult-Vaccine, single vaccination (An Open study)
    Group 5 (phase 2): 50 volunteers aged 18-50 years who will be the QazCoVac-P - COVID-19 single vaccination, intramuscularly, at a dose of 0.5 ml
    Intervention: Biological: QazCoVac-P -COVID-19 Subunit Vaccine
  • Experimental: Phase 2 Elderly-Vaccine, single vaccination (An Open study)
    Group 6 (phase 2): 50 volunteers from 50 years old and elder who will be the QazCoVac-P - COVID-19 single vaccination, intramuscularly, at a dose of 0.5 ml
    Intervention: Biological: QazCoVac-P -COVID-19 Subunit Vaccine
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: June 15, 2021) 		244
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 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 18-50 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
  • According to the results of a chest x-ray, there is no pathological process in the lungs.

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.
  • 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;
  • Negative PCR results for coronavirus SARS-CoV-2;
  • According to the results of a chest x-ray, there is no pathological process in the lungs;
  • Voluntary refusal to study;
  • Vulnerable Volunteers of research.
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 NCT04930003
Other Study ID Numbers  ICMJE QAZCOVAC-P-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 Not Provided
Responsible Party Research Institute for Biological Safety Problems
Study Sponsor  ICMJE Research Institute for Biological Safety Problems
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Kunsulu Zakarya, Ph.D. Research Institute for Biological Safety Problems
PRS Account Research Institute for Biological Safety Problems
Verification Date January 2021

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