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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 : Active, not recruiting
First Posted : August 28, 2020
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
National Scientific Center for Phthisiopulmonology of the Republic of Kazakhstan
Information provided by (Responsible Party):
Research Institute for Biological Safety Problems

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

Condition or disease Intervention/treatment Phase
Covid19 SARS-CoV Infection Vaccine Adverse Reaction Biological: QazCovid-in® - COVID-19 inactivated vaccine Other: Placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : September 19, 2020
Estimated Primary Completion Date : November 25, 2020
Estimated Study Completion Date : December 7, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Biological: QazCovid-in® - COVID-19 inactivated vaccine
QazCovid-in® (inactivated) 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
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)

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
Biological: QazCovid-in® - COVID-19 inactivated vaccine
QazCovid-in® (inactivated) 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 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
Biological: QazCovid-in® - COVID-19 inactivated vaccine
QazCovid-in® (inactivated) 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 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
Biological: QazCovid-in® - COVID-19 inactivated vaccine
QazCovid-in® (inactivated) 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 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
Biological: QazCovid-in® - COVID-19 inactivated vaccine
QazCovid-in® (inactivated) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan




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 ]
    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.


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.

  2. Cell-mediated immune profile [ Time Frame: at days 0, 7, 21, 27, 42 ]
    Cell-mediated immune profile



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 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.

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): NCT04530357


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
National Scientific Center for Phthisiopulmonology of the Republic of Kazakhstan
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
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Responsible Party: Research Institute for Biological Safety Problems
ClinicalTrials.gov Identifier: NCT04530357    
Other Study ID Numbers: QAZCOV-I/II-01/2020
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 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:
vaccine, I/II phase, safety, immunogenicity, QazCovid-in®
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases