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

NCT04930003 | Completed Phase 1 DMC

• 1 other identifier: QAZCOVAC-P-I/II-01/2020
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

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

Conditions

Covid19; SARS-CoV Infection; Vaccine Adverse Reaction

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Incidence of serious adverse events during the study

  throughout the study, an average of 42 days

Other Outcomes (1)

• Cell-mediated immune profile

  at days 0, 7, 21, 42

Study Arms (6)

Experimental: Phase 1 Adult-vaccine (A Sample, blind study)

EXPERIMENTAL

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

Phase 1 Adult-Placebo (A Sample, blind study)

PLACEBO COMPARATOR

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

Phase 2 Adult-Vaccine, twice vaccination (An Open study)

EXPERIMENTAL

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

Phase 2 Elderly-Vaccine, twice vaccination (An Open study)

EXPERIMENTAL

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

Phase 2 Adult-Vaccine, single vaccination (An Open study)

EXPERIMENTAL

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

Phase 2 Elderly-Vaccine, single vaccination (An Open study)

EXPERIMENTAL

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

Interventions

QazCoVac-P -COVID-19 Subunit Vaccine BIOLOGICAL

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

Experimental: Phase 1 Adult-vaccine (A Sample, blind study); Phase 2 Adult-Vaccine, single vaccination (An Open study); Phase 2 Adult-Vaccine, twice vaccination (An Open study); Phase 2 Elderly-Vaccine, single vaccination (An Open study); Phase 2 Elderly-Vaccine, twice vaccination (An Open study)

Placebo OTHER

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

Phase 1 Adult-Placebo (A Sample, blind study)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Research Institute for Biological Safety Problems: lead

Study Sites (1)

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

Gvardeyskiy, Jambul, 080409, Kazakhstan

Location

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kunsulu Zakarya, Ph.D.

  Research Institute for Biological Safety Problems

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Assignment

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: June 18, 2021
• Study Start: June 15, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: December 7, 2023

Record last verified: 2023-12

Locations

KA (1)