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

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

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

Study Overview

• Status: Completed
• Conditions: Covid19; Vaccine Adverse Reaction; SARS-CoV Infection
• Intervention / Treatment: Biological: QazCoVac-P -COVID-19 Subunit Vaccine; Other: Placebo

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: Interventional
• Enrollment (Actual): 244
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Kazakhstan
  • Jambul
    • Gvardeyskiy, Jambul, Kazakhstan, 080409
      • Research Institute for Biological Safety Problems Committee of Science of the Ministry of Education and Science of the Republic of Kazakhstan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of adverse events up to seven days after immunization	Frequency of adverse reaction in the seven days following each immunization per age group	Seven days after each immunization
Frequency of adverse events up to 21 days after immunization	Frequency of adverse reaction in the 21 days following each immunization per age group	21 days after each immunization
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	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.	at days 0, 21, 27, 42, 90, 180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of serious adverse events during the study	Incidence of serious adverse events during the study.	throughout the study, an average of 42 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cell-mediated immune profile	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.	at days 0, 7, 21, 42

Collaborators and Investigators

• Sponsor: Research Institute for Biological Safety Problems
• Investigators: Study Chair: Kunsulu Zakarya, Ph.D., Research Institute for Biological Safety Problems

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): December 15, 2021

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: June 15, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: safety,; vaccine,; immunogenicity,; I/II phase,; QazCoVac-P
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Severe Acute Respiratory Syndrome; COVID-19
• Other Study ID Numbers: QAZCOVAC-P-I/II-01/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No