Covid19Phase 1/2NCT04930003
Reactogenicity, Safety and Immunogenicity of QazCoVac-P COVID-19 Vaccine
A Phase 1/2 study testing QazCoVac-P -COVID-19 Subunit Vaccine in people with Covid19 and SARS-CoV Infection, run by Research Institute for Biological Safety Problems at 1 site in Kazakhstan.
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 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?
- QazCoVac-P -COVID-19 Subunit Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 244 participants
- Where
- 1 siteKazakhstan
- Study dates
- 15 Jun 2021to 15 Dec 2021
- Phase
- Phase 1/2
- 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 18-50 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.
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- 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.
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/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.
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- 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.
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
About this study
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
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
Read the detailed 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
- Conditions
- Covid19, SARS-CoV Infection, Vaccine Adverse Reaction
- Being tested
- QazCoVac-P -COVID-19 Subunit Vaccine, Placebo
- Keywords
- vaccine,, I/II phase,, safety,, immunogenicity,, QazCoVac-P
- 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.
QazCoVac-P -COVID-19 Subunit VaccineBiological
QazCoVac-P (Subunit) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan
PlaceboOther
The use of placebo: intramuscularly, twice, spaced 21 days apart, at a dose of 0.5 ml (22 volunteers)
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Phase 1 Adult-vaccine (A Sample, blind study) | Experimental | Group 1 (phase 1): 22 volunteers aged 18-50 years who will be the QazCoVac-P - COVID-19 twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml Receives: Biological: QazCoVac-P -COVID-19 Subunit Vaccine |
| Phase 1 Adult-Placebo (A Sample, blind study) | Placebo comparator | Group 2 (phase 1): 22 volunteers aged 18-50 years who will be the Placebo twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml Receives: Other: Placebo |
| Phase 2 Adult-Vaccine, twice vaccination (An Open study) | Experimental | Group 3 (phase 2): 50 volunteers aged 18-50 years who will be the QazCoVac-P - COVID-19 twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml Receives: Biological: QazCoVac-P -COVID-19 Subunit Vaccine |
| Phase 2 Elderly-Vaccine, twice vaccination (An Open study) | Experimental | Group 4 (phase 2): 50 volunteers from 50 years old and elder who will be the QazCoVac-P - COVID-19 twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml Receives: Biological: QazCoVac-P -COVID-19 Subunit Vaccine |
| Phase 2 Adult-Vaccine, single vaccination (An Open study) | Experimental | Group 5 (phase 2): 50 volunteers aged 18-50 years who will be the QazCoVac-P - COVID-19 single vaccination, intramuscularly, at a dose of 0.5 ml Receives: Biological: QazCoVac-P -COVID-19 Subunit Vaccine |
| Phase 2 Elderly-Vaccine, single vaccination (An Open study) | Experimental | Group 6 (phase 2): 50 volunteers from 50 years old and elder who will be the QazCoVac-P - COVID-19 single vaccination, intramuscularly, at a dose of 0.5 ml Receives: Biological: QazCoVac-P -COVID-19 Subunit Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: at days 0, 21, 27, 42, 90, 180
Secondary outcomes (1)
Incidence of serious adverse events during the study
Incidence of serious adverse events during the study.
Measured: throughout the study, an average of 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start15 Jun 2021
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Institute for Biological Safety Problems
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kunsulu Zakarya, Ph.D., Study chair, Research Institute for Biological Safety Problems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930003
- Sponsor's protocol ID
- QAZCOVAC-P-I/II-01/2020
- Status last verified
- Dec 2023
- First submitted
- 22 Feb 2021
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04930003
- Acronym / sponsor ID
- QAZCOVAC-P-I/II-01/2020
- Conditions
- Covid19, SARS-CoV Infection, Vaccine Adverse Reaction
- Keywords
- vaccine,, I/II phase,, safety,, immunogenicity,, QazCoVac-P
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Research Institute for Biological Safety ProblemsOther government
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 18 Jun 2021 (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.
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
Detailed 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- Assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental: Phase 1 Adult-vaccine (A Sample, blind study) | Experimental | Biological: QazCoVac-P -COVID-19 Subunit VaccineGroup 1 (phase 1): 22 volunteers aged 18-50 years who will be the QazCoVac-P - COVID-19 twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml |
| Phase 1 Adult-Placebo (A Sample, blind study) | Placebo comparator | Other: PlaceboGroup 2 (phase 1): 22 volunteers aged 18-50 years who will be the Placebo twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml |
| Phase 2 Adult-Vaccine, twice vaccination (An Open study) | Experimental | Biological: QazCoVac-P -COVID-19 Subunit VaccineGroup 3 (phase 2): 50 volunteers aged 18-50 years who will be the QazCoVac-P - COVID-19 twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml |
| Phase 2 Elderly-Vaccine, twice vaccination (An Open study) | Experimental | Biological: QazCoVac-P -COVID-19 Subunit VaccineGroup 4 (phase 2): 50 volunteers from 50 years old and elder who will be the QazCoVac-P - COVID-19 twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml |
| Phase 2 Adult-Vaccine, single vaccination (An Open study) | Experimental | Biological: QazCoVac-P -COVID-19 Subunit VaccineGroup 5 (phase 2): 50 volunteers aged 18-50 years who will be the QazCoVac-P - COVID-19 single vaccination, intramuscularly, at a dose of 0.5 ml |
| Phase 2 Elderly-Vaccine, single vaccination (An Open study) | Experimental | Biological: QazCoVac-P -COVID-19 Subunit VaccineGroup 6 (phase 2): 50 volunteers from 50 years old and elder who will be the QazCoVac-P - COVID-19 single vaccination, 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 (11 listed)
- 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.
Key exclusion criteria (19 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/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.
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 |
|---|---|---|
| QazCoVac-P -COVID-19 Subunit VaccineQazCoVac-P (Subunit) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan | Biological | Experimental: Phase 1 Adult-vaccine (A Sample, blind study), Phase 2 Adult-Vaccine, single vaccination (An Open study), Phase 2 Adult-Vaccine, twice vaccination (An Open study), Phase 2 Elderly-Vaccine, single vaccination (An Open study), Phase 2 Elderly-Vaccine, twice vaccination (An Open study) |
| PlaceboThe use of placebo: intramuscularly, twice, spaced 21 days apart, at a dose of 0.5 ml (22 volunteers) | Other | Phase 1 Adult-Placebo (A Sample, blind study) |
Primary outcome
Frequency of adverse events up to seven days after immunization
Time frame: Seven days after each immunization
Frequency of adverse reaction in the seven days following each immunization per age group
Frequency of adverse events up to 21 days after immunization
Time frame: 21 days after each immunization
Frequency of adverse reaction in the 21 days following each immunization per age group
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
Time frame: at days 0, 21, 27, 42, 90, 180
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.
1 secondary outcome
Incidence of serious adverse events during the study
Time frame: throughout the study, an average of 42 days
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 7 Dec 2023.
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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.
Kunsulu Zakarya, Ph.D. study chair
Research Institute for Biological Safety Problems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing QazCoVac-P -COVID-19 Subunit Vaccine 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 11 inclusion and 19 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 7 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Frequency of adverse events up to seven days after immunization (time frame: Seven days after each immunization). 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?
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 7 Dec 2023.