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

NCT04691908 | Completed Phase 3

• 1 other identifier: QAZCOV-III-01/2020
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

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

Conditions

Covid19; SARS-CoV Infection; Vaccine Adverse Reaction

Keywords

QazCovid-in®, vaccine, III phase, efficiency, safety, immunogenicity

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (4)

• Changing of antigen-specific cellular immunity level

  at days 0, 90, 180

• Frequency of adverse events up to seven days after immunization

  Seven days after each immunization

• Frequency of adverse events up to 21 days after immunization

  21 days after each immunization

• Incidence of serious adverse events during the study

  throughout the study, an average of 6 months

Study Arms (2)

Phase III Adult-vaccine (A Sample, blind study)

ACTIVE COMPARATOR

Group 1 (phase III): 2400 volunteers from 18 years old and elder who will be the QazCovid-in® twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml

Biological: QazCovid-in®-vaccine against COVID-19

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

PLACEBO COMPARATOR

Group 1 (phase III): 600 volunteers from 18 years old and elder who will be the Placebo twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml

Other: Placebo

Interventions

QazCovid-in®-vaccine against COVID-19 BIOLOGICAL

QazCovid-in® (inactivated) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan

Phase III Adult-vaccine (A Sample, blind study)

Placebo OTHER

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

Phase III 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 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.

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.
• 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.

Sponsors & Collaborators

• Research Institute for Biological Safety Problems: lead
• City polyclinic No. 4 of the of Almaty Ministry of Healthcare of the Republic of Kazakhstan: collaborator
• Clinic of the International Institute of Postgraduate Education Ministry of Healthcare of the Republic of Kazakhstan: collaborator
• City Multidisciplinary Hospital of Zhambyl Region Ministry of Healthcare of the Republic of Kazakhstan: collaborator

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

Related Publications (1)

• 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.

  PMID: 35770251 DERIVED

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

• Berik Khairullin, PhD

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

  STUDY DIRECTOR

• Kunsulu Zakarya, PhD

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

  STUDY CHAIR

• IIlyas Kulmagambetov, PhD

  Centre for Clinical Medicine and Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 31, 2020
• Study Start: December 25, 2020
• Primary Completion: April 26, 2021
• Study Completion: July 11, 2021
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)