COVID-19 PneumoniaPhase 4NCT05065892
Evaluation of Immunogenicity and Safety of COVID-19 Vaccine (Produced in Wuhan) in Patients With Hypertension and/or Diabetes
A Phase 4 study testing COVAX in people with COVID-19 Pneumonia, run by China National Biotec Group Company Limited at 3 sites in China.
Trial summary
To evaluate the post-marketing immunogenicity and safety of the inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine (Vero cells) in patients aged 60 years or older with hypertension and/or diabetes, thus to further collect the immunogenicity and safety data of this product in special… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- COVAX
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,440 participants
- Where
- 3 sitesChina
- Study dates
- Oct 2021to Mar 2022
- Phase
- Phase 4
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥60 years old individuals with full civil capacity.
- Clinically confirmed body temperature of <37.3°C before enrolling in this study.
- Able and willing to participate in the study plan during the entire study and follow-up period.
- Capable of understanding the study procedures, willing to sign the informed consent form, and able to comply with the requirements of the clinical study protocol.
- Inclusion criteria for patients with hypertension and/or diabetes: Hypertension and/or diabetes definitively diagnosed by a community-level or higher medical institution. Patients with hypertension: systolic pressure <160 mmHg and diastolic pressure <100 mmHg on the day of immunization achieved by lifestyle adjustment and/or drug treatment; patients with diabetes: fasting glucose ≤13.9 mmol/L on the day of (or within 3 days before) immunization achieved by lifestyle adjustment and/or drug treatment.
Who cannot join
- Previously confirmed or asymptomatic COVID-19 patient.
- Has been immunized with a SARS-CoV-2 vaccine.
- Illiterate.
- Known allergy to any ingredient (including excipient) of this product.
- Received non-specific immunoglobulin injection within 1 month before enrollment.
- Received a live attenuated vaccine within 1 month before immunization or other vaccine within 14 days before immunization.
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- Previous serious allergy to vaccine (e.g., acute allergic reaction, urticaria, angioedema, and dyspnea).
- Has uncontrolled epilepsy and other progressive neurological disorders; history of Guillain-Barré syndrome.
- Severe respiratory disorders, severe hepatic and renal diseases, malignancies, and various acute diseases or acute onset of chronic diseases.
- Diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases.
- Definitively diagnosed with thrombocytopenia or history of other coagulation disorders that may cause subcutaneous injection to be contraindicated.
- Currently experiencing acute complications (ketoacidosis, hyperosmolar state, lactic acidosis, etc.) of diabetes; or within 2 weeks after recovery from these complications.
- Other physical conditions judged by the investigator that render the patient unsuitable for participation in the clinical study.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Nan'an Center for Disease Control and Prevention
Quanzhou, Fujian
Siqun HU, +86-15880960857
Songtao Miao Autonomous County Center for Disease Control and Prevention
Tongren, Guizhou
Jie TAN, +86-18311709889
You County Center for Disease Control and Prevention
Zhuzhou, Hunan
Zixiong LIU, +86-13974179882
About this study
Official title: A Post-marketing Clinical Study of the Inactivated SARS-CoV-2 Vaccine (Vero Cells) (Produced in Wuhan): Immunogenicity and Safety Assessments in Patients With Hypertension and/or Diabetes
To evaluate the post-marketing immunogenicity and safety of the inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine (Vero cells) in patients aged 60 years or older with hypertension and/or diabetes, thus to further collect the immunogenicity and safety data of this product in special populations.
Read the detailed description
After giving informed consent, patients with hypertension, patients with diabetes, patients with both diseases, and healthy controls, all aged 60 years or older, were given two doses of the inactivated SARS-CoV-2 vaccine (Vero cells). Venous blood samples were collected before the first dose and on day 28 after the second dose to evaluate the immunogenicity of the vaccine. Adverse events were actively recorded on a diary card once daily from day 0 to day 7 and once from day 8 to day 21 after the first dose and the second dose. Within 3 months after immunization with the second dose and collection of diary cards, the subjects were followed up by phone once a month as well as self-report to collect serious adverse events.
- Conditions
- COVID-19 Pneumonia
- Being tested
- COVAX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVAXBiological
2 doses of Covid-19 vaccine
| Study group | Role | What they receive |
|---|---|---|
| Hypertension group | Experimental | Hypertension group will enroll 330 subjects with hypertension (aged 60 years or older). Receives: Biological: COVAX |
| Diabetes Mellitus group | Experimental | Diabetes group will enroll 330 subjects with diabetes (aged 60 years or older). Receives: Biological: COVAX |
| Combined Disease group | Experimental | Combined Diseases group will enroll 300 subjects with both hypertension and diabetes (aged 60 years or older). Receives: Biological: COVAX |
| Healthy people group | Active comparator | Healthy people group will enroll 480 subjects with no medical history of hypertension or diabetes (aged 60 years or older). Receives: Biological: COVAX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate
the rate of positive seroconversion against coronavirus
Measured: Up to 28 days after the second dose
Neutralizing antibody level
neutralizing antibody level against coronavirus
Measured: Up to 28 days after the second dose
Secondary outcomes (1)
Adverse events following vaccination
analyse the incidence of adverse events following immunization, both solicited and unsolicited
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study startOct 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Biotec Group Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guizhou Center for Disease Control and Prevention, Hunan Provincial Center for Disease Control and Prevention, Center for Disease Control and Prevention, Fujian, Wuhan Institute of Biological Products Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065892
- Sponsor's protocol ID
- COVAX (HT/DM)-Wuhan
- Status last verified
- Oct 2021
- First submitted
- 28 Sep 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-marketing Clinical Study of the Inactivated SARS-CoV-2 Vaccine (Vero Cells) (Produced in Wuhan): Immunogenicity and Safety Assessments in Patients With Hypertension and/or Diabetes
- ClinicalTrials.gov ID
- NCT05065892
- Acronym / sponsor ID
- COVAX (HT/DM)-Wuhan
- Conditions
- COVID-19 Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,440 participants (estimated)
- Lead sponsor
- China National Biotec Group Company LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Guizhou Center for Disease Control and Prevention, Hunan Provincial Center for Disease Control and Prevention, Center for Disease Control and Prevention, Fujian, Wuhan Institute of Biological Products Co., Ltd
- Study start
- Oct 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 4 Oct 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.
To evaluate the post-marketing immunogenicity and safety of the inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine (Vero cells) in patients aged 60 years or older with hypertension and/or diabetes, thus to further collect the immunogenicity and safety data of this product in special populations.
Detailed description
After giving informed consent, patients with hypertension, patients with diabetes, patients with both diseases, and healthy controls, all aged 60 years or older, were given two doses of the inactivated SARS-CoV-2 vaccine (Vero cells). Venous blood samples were collected before the first dose and on day 28 after the second dose to evaluate the immunogenicity of the vaccine. Adverse events were actively recorded on a diary card once daily from day 0 to day 7 and once from day 8 to day 21 after the first dose and the second dose. Within 3 months after immunization with the second dose and collection of diary cards, the subjects were followed up by phone once a month as well as self-report to collect serious adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hypertension group | Experimental | Biological: COVAXHypertension group will enroll 330 subjects with hypertension (aged 60 years or older). |
| Diabetes Mellitus group | Experimental | Biological: COVAXDiabetes group will enroll 330 subjects with diabetes (aged 60 years or older). |
| Combined Disease group | Experimental | Biological: COVAXCombined Diseases group will enroll 300 subjects with both hypertension and diabetes (aged 60 years or older). |
| Healthy people group | Active comparator | Biological: COVAXHealthy people group will enroll 480 subjects with no medical history of hypertension or diabetes (aged 60 years or older). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥60 years old individuals with full civil capacity.
- Clinically confirmed body temperature of <37.3°C before enrolling in this study.
- Able and willing to participate in the study plan during the entire study and follow-up period.
- Capable of understanding the study procedures, willing to sign the informed consent form, and able to comply with the requirements of the clinical study protocol.
- Inclusion criteria for patients with hypertension and/or diabetes: Hypertension and/or diabetes definitively diagnosed by a community-level or higher medical institution. Patients with hypertension: systolic pressure <160 mmHg and diastolic pressure <100 mmHg on the day of immunization achieved by lifestyle adjustment and/or drug treatment; patients with diabetes: fasting glucose ≤13.9 mmol/L on the day of (or within 3 days before) immunization achieved by lifestyle adjustment and/or drug treatment.
Key exclusion criteria (13 listed)
- Previously confirmed or asymptomatic COVID-19 patient.
- Has been immunized with a SARS-CoV-2 vaccine.
- Illiterate.
- Known allergy to any ingredient (including excipient) of this product.
- Received non-specific immunoglobulin injection within 1 month before enrollment.
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 |
|---|---|---|
| COVAX2 doses of Covid-19 vaccine | Biological | Combined Disease group, Diabetes Mellitus group, Healthy people group, Hypertension group |
Primary outcome
Seroconversion rate
Time frame: Up to 28 days after the second dose
the rate of positive seroconversion against coronavirus
Neutralizing antibody level
Time frame: Up to 28 days after the second dose
neutralizing antibody level against coronavirus
1 secondary outcome
Adverse events following vaccination
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing COVAX in people with COVID-19 Pneumonia, run by China National Biotec Group Company Limited at 3 sites in China.
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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruizhi ZHANG (+86-13985441115, 919987774@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion rate (time frame: Up to 28 days after the second dose). The study lists 2 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 25 Oct 2021.