Clinical trial NCT04691908: Immunogenicity, Efficacy and Safety of QazCovid-in® COVID-19 Vaccine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Covid19
SARS-CoV Infection
Vaccine Adverse Reaction
Keywords: QazCovid-in®, vaccine, III phase, efficiency, safety, immunogenicity
Lead sponsor: Research Institute for Biological Safety Problems
Sponsor class: OTHER_GOV
Collaborators: name: City polyclinic No. 4 of the of Almaty Ministry of Healthcare of the Republic of Kazakhstan
name: Clinic of the International Institute of Postgraduate Education Ministry of Healthcare of the Republic of Kazakhstan
name: City Multidisciplinary Hospital of Zhambyl Region Ministry of Healthcare of the Republic of Kazakhstan
First posted: 2020-12-31
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Terms of seroconversion (the proportion of persons with a fourfold or higher change in antibody titers to SARS-CoV-2)
timeFrame: at days 0, 21, 42, 90, 180
measure: To evaluate the immunogenicity of the QazCovid-in® vaccine inactivated against COVID-19 versus placebo
timeFrame: at days 0, 21, 42, 90, 180
measure: Frequency of confirmed cases of COVID-19
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Changing of antigen-specific cellular immunity level
timeFrame: at days 0, 90, 180
measure: Frequency of adverse events up to seven days after immunization
timeFrame: Seven days after each immunization
measure: Frequency of adverse events up to 21 days after immunization
timeFrame: 21 days after each immunization
measure: Incidence of serious adverse events during the study
timeFrame: throughout the study, an average of 6 months
Other outcomes:
Locations:
city: Gvardeyskiy
country: Kazakhstan
facility: Research Institute for Biological Safety Problems Committee of Science of the Ministry of Education and Science of the Republic of Kazakhstan
state: Jambul
Study officials:
affiliation: Research Institute for Biological Safety Problems Committee of Science of the Ministry of Education and Science of the Republic of Kazakhstan
name: Berik Khairullin, PhD
role: STUDY_DIRECTOR
affiliation: Research Institute for Biological Safety Problems Committee of Science of the Ministry of Education and Science of the Republic of Kazakhstan
name: Kunsulu Zakarya, PhD
role: STUDY_CHAIR
affiliation: Centre for Clinical Medicine and Research
name: IIlyas Kulmagambetov, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khairullin B, Zakarya K, Orynbayev M, Abduraimov Y, Kassenov M, Sarsenbayeva G, Sultankulova K, Chervyakova O, Myrzakhmetova B, Nakhanov A, Nurpeisova A, Zhugunissov K, Assanzhanova N, Nurabayev S, Kerimbayev A, Yershebulov Z, Burashev Y, Kulmagambetov I, Davlyatshin T, Sergeeva M, Buzitskaya Z, Stukova M, Kutumbetov L. Efficacy and safety of an inactivated whole-virion vaccine against COVID-19, QazCovid-in(R), in healthy adults: A multicentre, randomised, single-blind, placebo-controlled phase 3 clinical trial with a 6-month follow-up. EClinicalMedicine. 2022 Jun 25;50:101526. doi: 10.1016/j.eclinm.2022.101526. eCollection 2022 Aug.