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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04930003
Other study ID # QAZCOVAC-P-I/II-01/2020
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date June 15, 2021
Est. completion date December 15, 2021

Study information

Verified date December 2023
Source Research Institute for Biological Safety Problems
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 244
Est. completion date December 15, 2021
Est. primary completion date December 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
Kazakhstan Research Institute for Biological Safety Problems Committee of Science of the Ministry of Education and Science of the Republic of Kazakhstan Gvardeyskiy Jambul

Sponsors (1)

Lead Sponsor Collaborator
Research Institute for Biological Safety Problems

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Primary 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
Primary 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
Primary 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 Incidence of serious adverse events during the study Incidence of serious adverse events during the study. throughout the study, an average of 42 days
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