Covid19Phase 3NCT04691908

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

A Phase 3 study testing QazCovid-in®-vaccine against COVID-19 in people with Covid19 and SARS-CoV Infection, run by Research Institute for Biological Safety Problems at 1 site in Kazakhstan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 Read more about this study

Who is it for?: Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for: Covid19, SARS-CoV Infection, Vaccine Adverse Reaction
What is being tested?: QazCovid-in®-vaccine against COVID-19
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 3,000 participants
Where: 1 siteKazakhstan
Study dates: 25 Dec 2020to 11 Jul 2021
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Kazakhstan1 site

Research Institute for Biological Safety Problems Committee of Science of the Ministry of Education and Science of the Republic of Kazakhstan
Gvardeyskiy, Zhambyl, 080409

Other trials in Kazakhstan

About this study

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

Read the 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.

Conditions: Covid19, SARS-CoV Infection, Vaccine Adverse Reaction
Being tested: QazCovid-in®-vaccine against COVID-19, Placebo
Keywords: QazCovid-in®, vaccine, III phase, efficiency, safety, immunogenicity
Medical subject headings: COVID-19, Severe Acute Respiratory Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QazCovid-in®-vaccine against COVID-19Biological
QazCovid-in® (inactivated) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan
PlaceboOther
Placebo (sodium chloride buffs, solvent for the preparation of dosage forms for injection 0.9%)

Study groups in NCT04691908
Study group	Role	What they receive
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 Receives: 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 Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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.
Measured: 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
Measured: through study completion, an average of 6 months

Secondary outcomes (4)

Changing of antigen-specific cellular immunity level
Determination of the level of production of intracellular cytokines by antigen-activated T-lymphocytes
Measured: at days 0, 90, 180
Frequency of adverse events up to seven days after immunization
Frequency of adverse reaction in the seven days following each immunization per age group
Measured: Seven days after each immunization
Frequency of adverse events up to 21 days after immunization
Frequency of adverse reaction in the 21 days following each immunization per age group
Measured: 21 days after each immunization
Incidence of serious adverse events during the study
Incidence of serious adverse events during the study
Measured: throughout the study, an average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Dec 202011 Jul 2021

First posted31 Dec 2020
Study start25 Dec 2020
Primary completion26 Apr 2021
Study completion11 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Covid19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 3,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04691908
Sponsor's protocol ID: QAZCOV-III-01/2020
Status last verified: Dec 2023
First submitted: 21 Dec 2020
Last updated: 13 Dec 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 35770251

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04691908
Acronym / sponsor ID: QAZCOV-III-01/2020
Conditions: Covid19, SARS-CoV Infection, Vaccine Adverse Reaction
Keywords: QazCovid-in®, vaccine, III phase, efficiency, safety, immunogenicity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,000 participants (actual)
Lead sponsor: Research Institute for Biological Safety ProblemsOther government
Collaborators: 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, City Multidisciplinary Hospital of Zhambyl Region Ministry of Healthcare of the Republic of Kazakhstan
Study start: 25 Dec 2020 (actual)
Primary completion: 26 Apr 2021 (actual)
Study completion: 11 Jul 2021 (actual)
First posted: 31 Dec 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Phase III Adult-vaccine (A Sample, blind study)	Active comparator	Biological: QazCovid-in®-vaccine against COVID-19Group 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
Phase III Adult-Placebo (A Sample, blind study)	Placebo comparator	Other: PlaceboGroup 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

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
QazCovid-in®-vaccine against COVID-19QazCovid-in® (inactivated) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan	Biological	Phase III Adult-vaccine (A Sample, blind study)
PlaceboPlacebo (sodium chloride buffs, solvent for the preparation of dosage forms for injection 0.9%)	Other	Phase III Adult-Placebo (A Sample, blind study)

Primary outcome

Terms of seroconversion (the proportion of persons with a fourfold or higher change in antibody titers to SARS-CoV-2)
Time frame: at days 0, 21, 42, 90, 180
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)
To evaluate the immunogenicity of the QazCovid-in® vaccine inactivated against COVID-19 versus placebo
Time frame: at days 0, 21, 42, 90, 180
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.
Frequency of confirmed cases of COVID-19
Time frame: through study completion, an average of 6 months
The presence of clinical manifestations and a positive laboratory test for SARS-CoV-2 virus RNA within 6 months after vaccination

4 secondary outcomes

Changing of antigen-specific cellular immunity level
Time frame: at days 0, 90, 180
Frequency of adverse events up to seven days after immunization
Time frame: Seven days after each immunization
Frequency of adverse events up to 21 days after immunization
Time frame: 21 days after each immunization
Incidence of serious adverse events during the study
Time frame: throughout the study, an average of 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
Derived from this study: PubMed 35770251Khairullin 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Berik Khairullin, PhD study director

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

Kunsulu Zakarya, PhD study chair

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

IIlyas Kulmagambetov, PhD principal investigator

Centre for Clinical Medicine and Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing QazCovid-in®-vaccine against COVID-19 in people with Covid19 and SARS-CoV Infection, run by Research Institute for Biological Safety Problems at 1 site in Kazakhstan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Terms of seroconversion (the proportion of persons with a fourfold or higher change in antibody titers to SARS-CoV-2) (time frame: at days 0, 21, 42, 90, 180). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04691908, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.