COVID-19 PneumoniaPhase 4NCT05104437
Evaluation of Immunogenicity, Safety and Antibody Persistence of COVID-19 Booster Vaccine (Produced in Wuhan) in Patients With Hypertension and/or Diabetes
A Phase 4 study testing Covid-19 vaccine (0-1-4 schedule) and Covid-19 vaccine (0-1-6 schedule) 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, safety and antibody persistence of the third dose (booster) of Covid-19 vaccine in patients aged 60 years or older with hypertension and/or diabetes. 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?
- Covid-19 vaccine (0-1-4 schedule) and Covid-19 vaccine (0-1-6 schedule)
- 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
- Nov 2021to Dec 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
- Participate in the clinical trial "NCT05065892".
- ≥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
Songtao Miao Autonomous County Center for Disease Control and Prevention
Tongren, Guizhou
You County Center for Disease Control and Prevention
Zhuzhou, Hunan
About this study
Official title: A Post-marketing Clinical Study of a Third Dose of the Inactivated SARS-CoV-2 Vaccine (Vero Cells) (Produced in Wuhan): Immunogenicity, Safety and Antibody Persistence Assessments in Patients With Hypertension and/or Diabetes
To evaluate the post-marketing immunogenicity, safety and antibody persistence of the third dose (booster) of Covid-19 vaccine in patients aged 60 years or older with hypertension and/or diabetes.
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, are given a third doses of the inactivated SARS-CoV-2 vaccine (Vero cells).
These subjects are all from the "COVAX (HT/DM)-Wuhan" clinical trial (NCT05065892). 50% of them receive the booster vaccine 3 months after the second dose (0-1-4 schedule); 50% of them receive the booster vaccine 5 months after the second dose (0-1-6 schedule).
Venous blood samples are collected before the booster dose and on day 28 after the booster dose to evaluate the immunogenicity of the vaccine.
Venous blood samples are also collected on day 84/168/252/336 after the booster dose to evaluate the antibody persistence of the vaccine.
Adverse events are actively recorded on a diary card once daily from day 0 to day 7 and once from day 8 to day 21 after the booster dose. Serious adverse events (SAE) are collected within 6 months after the booster dose.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Covid-19 vaccine (0-1-4 schedule), Covid-19 vaccine (0-1-6 schedule)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covid-19 vaccine (0-1-4 schedule)Biological
Subjects receive the booster vaccine 3 months after the second dose.
Covid-19 vaccine (0-1-6 schedule)Biological
Subjects receive the booster vaccine 5 months after the second dose.
| Study group | Role | What they receive |
|---|---|---|
| 0-1-4 schedule group | Experimental | Subjects receive the booster vaccine 3 months after the second dose. Receives: Biological: Covid-19 vaccine (0-1-4 schedule) |
| 0-1-6 schedule group | Experimental | Subjects receive the booster vaccine 5 months after the second dose. Receives: Biological: Covid-19 vaccine (0-1-6 schedule) |
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 booster dose
Neutralizing antibody level
neutralizing antibody level against coronavirus
Measured: Up to 28 days after the booster dose
Neutralizing antibody level
neutralizing antibody level against coronavirus
Measured: Up to 84 days after the booster dose
Neutralizing antibody level
neutralizing antibody level against coronavirus
Measured: Up to 168 days after the booster dose
Neutralizing antibody level
neutralizing antibody level against coronavirus
Measured: Up to 252 days after the booster dose
Neutralizing antibody level
neutralizing antibody level against coronavirus
Measured: Up to 336 days after the booster 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 after the booster dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study startNov 2021 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionDec 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
- NCT05104437
- Sponsor's protocol ID
- COVAX BOOSTER (HT/DM)-Wuhan
- Status last verified
- Oct 2021
- First submitted
- 30 Oct 2021
- Last updated
- 3 Nov 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 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-marketing Clinical Study of a Third Dose of the Inactivated SARS-CoV-2 Vaccine (Vero Cells) (Produced in Wuhan): Immunogenicity, Safety and Antibody Persistence Assessments in Patients With Hypertension and/or Diabetes
- ClinicalTrials.gov ID
- NCT05104437
- Acronym / sponsor ID
- COVAX BOOSTER (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
- Nov 2021 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 3 Nov 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, safety and antibody persistence of the third dose (booster) of Covid-19 vaccine in patients aged 60 years or older with hypertension and/or diabetes.
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, are given a third doses of the inactivated SARS-CoV-2 vaccine (Vero cells).
These subjects are all from the "COVAX (HT/DM)-Wuhan" clinical trial (NCT05065892). 50% of them receive the booster vaccine 3 months after the second dose (0-1-4 schedule); 50% of them receive the booster vaccine 5 months after the second dose (0-1-6 schedule).
Venous blood samples are collected before the booster dose and on day 28 after the booster dose to evaluate the immunogenicity of the vaccine.
Venous blood samples are also collected on day 84/168/252/336 after the booster dose to evaluate the antibody persistence of the vaccine.
Adverse events are actively recorded on a diary card once daily from day 0 to day 7 and once from day 8 to day 21 after the booster dose. Serious adverse events (SAE) are collected within 6 months after the booster dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0-1-4 schedule group | Experimental | Biological: Covid-19 vaccine (0-1-4 schedule)Subjects receive the booster vaccine 3 months after the second dose. |
| 0-1-6 schedule group | Experimental | Biological: Covid-19 vaccine (0-1-6 schedule)Subjects receive the booster vaccine 5 months after the second dose. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participate in the clinical trial "NCT05065892".
- ≥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.
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 |
|---|---|---|
| Covid-19 vaccine (0-1-4 schedule)Subjects receive the booster vaccine 3 months after the second dose. | Biological | 0-1-4 schedule group |
| Covid-19 vaccine (0-1-6 schedule)Subjects receive the booster vaccine 5 months after the second dose. | Biological | 0-1-6 schedule group |
Primary outcome
Seroconversion rate
Time frame: Up to 28 days after the booster dose
the rate of positive seroconversion against coronavirus
Neutralizing antibody level
Time frame: Up to 28 days after the booster dose
neutralizing antibody level against coronavirus
Neutralizing antibody level
Time frame: Up to 84 days after the booster dose
neutralizing antibody level against coronavirus
Neutralizing antibody level
Time frame: Up to 168 days after the booster dose
neutralizing antibody level against coronavirus
Neutralizing antibody level
Time frame: Up to 252 days after the booster dose
neutralizing antibody level against coronavirus
Neutralizing antibody level
Time frame: Up to 336 days after the booster dose
neutralizing antibody level against coronavirus
1 secondary outcome
Adverse events following vaccination
Time frame: Up to 6 months after the booster dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 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 Covid-19 vaccine (0-1-4 schedule) and Covid-19 vaccine (0-1-6 schedule) 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 6 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 3 Nov 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 booster dose). The study lists 6 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 3 Nov 2021.