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

NCT ID: NCT04930003

Last Updated: 2023-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 244 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-15
• Study Completion Date: 2021-12-15

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

Conditions

Covid19; SARS-CoV Infection; Vaccine Adverse Reaction

Keywords

vaccine,; I/II phase,; safety,; immunogenicity,; QazCoVac-P

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

QazCoVac-P -COVID-19 Subunit Vaccine

Intervention Type: BIOLOGICAL

QazCoVac-P (Subunit) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

The use of placebo: intramuscularly, twice, spaced 21 days apart, at a dose of 0.5 ml (22 volunteers)

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

Group Type: EXPERIMENTAL

QazCoVac-P -COVID-19 Subunit Vaccine

Intervention Type: BIOLOGICAL

QazCoVac-P (Subunit) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan

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

Group Type: EXPERIMENTAL

QazCoVac-P -COVID-19 Subunit Vaccine

Intervention Type: BIOLOGICAL

QazCoVac-P (Subunit) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan

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

Group Type: EXPERIMENTAL

QazCoVac-P -COVID-19 Subunit Vaccine

Intervention Type: BIOLOGICAL

QazCoVac-P (Subunit) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan

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

Group Type: EXPERIMENTAL

QazCoVac-P -COVID-19 Subunit Vaccine

Intervention Type: BIOLOGICAL

QazCoVac-P (Subunit) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan

Interventions

QazCoVac-P -COVID-19 Subunit Vaccine

QazCoVac-P (Subunit) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan

Intervention Type: BIOLOGICAL

Placebo

The use of placebo: intramuscularly, twice, spaced 21 days apart, at a dose of 0.5 ml (22 volunteers)

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Research Institute for Biological Safety Problems

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kunsulu Zakarya, Ph.D.

Role: STUDY_CHAIR

Research Institute for Biological Safety Problems

Locations

Research Institute for Biological Safety Problems Committee of Science of the Ministry of Education and Science of the Republic of Kazakhstan

Gvardeyskiy, Jambul, Kazakhstan

Countries

Kazakhstan

Other Identifiers

QAZCOVAC-P-I/II-01/2020

Identifier Type: -

Identifier Source: org_study_id