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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04930003
• Other study ID #: QAZCOVAC-P-I/II-01/2020
• Status: Completed
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome
• Vaccine Adverse Reaction

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