Immunogenicity, Efficacy and Safety of QazCovid-in® COVID-19 Vaccine

Covid19 Clinical Trial

Official title:

Multicenter, Randomized, Blind, Placebo-controlled Clinical Study of III Phase on Assessment of Preventive Efficiency, Safety and Immunogenicity QazCovid-in®-Vaccine Against COVID-19 in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04691908
• Other study ID #: QAZCOV-III-01/2020
• Status: Completed
• Phase: Phase 3
• Start date: December 25, 2020
• Est. completion date: July 11, 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

Multicenter, randomized, blind, placebo-controlled clinical study of III phases on the assessment of preventive efficiency, safety and immunogenicity QazCovid-in®-vaccine against COVID-19 in healthy adult volunteers

Description:

The main objective of the study is to prove the superiority of the QazCovid-in®-vaccine inactivated against COVID-19 in comparison with placebo in terms of seroconversion (the proportion of persons with a fourfold or higher increase in antibody titers to SARS-CoV-2) on the 21st, 42nd day, 90th and 180th days after vaccination.

To evaluate the immunogenicity of the QazCovid-in® vaccine inactivated against COVID-19 versus placebo.

Evaluate vaccine efficacy.

Evaluate the safety of vaccine versus placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: July 11, 2021
• Est. primary completion date: April 26, 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 and above. Ability and voluntary desire to independently keep records in the Self-Observation 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.

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.

History of chronic alcohol abuse and/or drug use. Positive results for antibodies IgM, IgG to SARS-CoV-2 Women with a positive urine pregnancy test. Simultaneous treatment with immunosuppressive drugs, incl. 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, heart attack myocardium, severe hypertension not controlled by drugs, etc.), identified based on the data of the medical history, physical examination, which, according to the researcher, may affect the study result.

History of platelet disorder or other blood clotting disorders that may cause contraindications to intramuscular administration.

History of leukemia or neoplasm. Persons with autoimmune diseases. A history of Guillain-Barré syndrome or other neuroimmunological diseases. Subjects who received antiviral drugs, immunoglobulins or blood transfusions or any other investigational drug within 4 weeks prior to study drug administration; Subjects who received anti-inflammatory drugs 2 days prior to study drug administration; Participation in any other clinical research within the last 6 months. Subjects with regard to whom there is a concern that they will not comply with the requirements of the study, or persons with severe physical or mental disabilities that may affect the completion of the study.

Voluntary refusal to study. Vulnerable research subjects.

Related Conditions & MeSH terms

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

Intervention

Biological:
• QazCovid-in®-vaccine against COVID-19
QazCovid-in® (inactivated) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan

Other:
• Placebo
Placebo (sodium chloride buffs, solvent for the preparation of dosage forms for injection 0.9%)

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 (4)

Lead Sponsor	Collaborator
Research Institute for Biological Safety Problems	City Multidisciplinary Hospital of Zhambyl Region Ministry of Healthcare of the Republic of Kazakhstan, City polyclinic No. 4 of the of Almaty Ministry of Healthcare of the Republic of Kazakhstan, Clinic of the International Institute of Postgraduate Education Ministry of Healthcare of the Republic of Kazakhstan

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Terms of seroconversion (the proportion of persons with a fourfold or higher change in antibody titers to SARS-CoV-2)	The main objective of the study is to prove the superiority of the QazCovid-in®-vaccine inactivated against COVID-19 in comparison with placebo in terms of seroconversion (the proportion of persons with a fourfold or higher change in antibody titers to SARS-CoV-2)	at days 0, 21, 42, 90, 180
Primary	To evaluate the immunogenicity of the QazCovid-in® vaccine inactivated against COVID-19 versus placebo	The geometric mean titer of serum antibodies ELISA to SARS-CoV-2 after vaccination. The multiplicity of the change in the geometric mean titer of serum antibodies to SARS-CoV-2 after vaccination.	at days 0, 21, 42, 90, 180
Primary	Frequency of confirmed cases of COVID-19	The presence of clinical manifestations and a positive laboratory test for SARS-CoV-2 virus RNA within 6 months after vaccination	through study completion, an average of 6 months
Secondary	Changing of antigen-specific cellular immunity level	Determination of the level of production of intracellular cytokines by antigen-activated T-lymphocytes	at days 0, 90, 180
Secondary	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
Secondary	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
Secondary	Incidence of serious adverse events during the study	Incidence of serious adverse events during the study	throughout the study, an average of 6 months