HemolysisPhase 4NCT05480436
Immunogenicity and Safety of BBIBP-Corv Coadministered With PPV23 and IIV4 in Hemodialysis Population
A Phase 4 study testing coadministration, COVID-19 vaccine and IIV4+PPV23 in people with Hemolysis and COVID-19, run by China National Biotec Group Company Limited at 3 sites in China.
Trial summary
Evaluation of immunogenicity and safety of inactivated COVID-19 vaccine (BBIBP-Corv) coadministered with PPV23 and IIV4 in hemodialysis population. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- coadministration, COVID-19 vaccine and IIV4+PPV23
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 3 sitesChina
- Study dates
- 5 Aug 2022to 30 Jul 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants were hemodialysis patients aged ≥18 years.
- The duration of dialysis of the participants was ≥3 months.
- The life expectancy of participants was ≥2 years.
- Participants who have not previously been infected with SARS-CoV-2.
- Participants had not received any COVID-19 vaccine and had not received any influenza or pneumonia vaccine within 1 year.
- For female participants of reproductive age, they had no fertility plan within the first 3 months and had taken effective contraceptive measures within 2 weeks ; For male participants of reproductive age, no fertility plans were made within 3 months.
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- Be able and willing to complete the entire study plan during the study follow-up period.
- Have the ability to understand the study procedures, voluntarily sign informed consent.
- Body temperature < 37.3 °C confirmed by clinical examination before enrollment .
- Systolic blood pressure (SBP) was < 160 mmHg and diastolic blood pressure (DBP) was< 100 mmHg , and fasting blood glucose (FPG) was ≤13.9 mmol/L on the day of enrollment.
- Female participants of reproductive age were not pregnant.
Who cannot join
- Being allergic to any component of vaccines and a history of severe allergic reactions to any vaccine or allergic to pollen, food and other common allergens, or a history of allergic reaction to eating eggs or using gentamicin sulfate.
- Participants with uncontrolled epilepsy or a history or family history of epilepsy, a history of Guillain-Barre syndrome, Reye syndrome, and other progressive diseases.
- Participants were confirmed to be infected with H1N1, H3N2, BY and BV influenza viruses within 6 months.
- Pregnant and lactating women.
- Participants were in the period of acute illness or acute onset of chronic disease, and the acute complication has been cured for less than two weeks.
- Participants with acute febrile diseases and infectious diseases (including hepatitis B, hepatitis C, HIV patients and carriers, as well as patients with suspected pulmonary tuberculosis symptoms such as hemoptysis, night sweats and weight loss).
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- Participants with congenital immunodeficiency or currently receiving immunosuppressive therapy (oral steroid hormones, calcineurin inhibitors (CNIs), rituximab, long-term glucocorticoid use ≥1 week).
- Participants injected with non-specific immunoglobulin within 30 days.
- Participants received attenuated vaccines within 30 days and inactivated or other vaccines within 14 days.
- Serious drug adverse reactions and drug-related complications occurred during dialysis treatment.
- Participants with severe cardiovascular diseases (e.g., myocardial infarction, heart failure, malignant arrhythmia).
- Participants with infectious, suppurative and allergic skin diseases or severe skin itching (refers to the widespread and persistent attack; Affecting self-regulated activities of daily living or sleep; Systemic glucocorticoid or immunosuppressive therapy is required).
- Participants with malignant tumors.
- Participants had a history of seizures, encephalopathy, or psychiatric disorders (depressive mania, depression, schizophrenia, etc.).
- Other Participants whose physical conditions, as determined by the investigator, are not suitable for inclusion in clinical studies.
- Participants who need medical intervention (except blood glucose) after laboratory tests (blood routine, blood biochemical, coagulation routine) are judged by the investigator.
- Participants had a history of clearly diagnosed thrombocytopenia or other coagulation disorders, which may be contraindicated as subcutaneous injections
- The participant did not inform the investigator in time of any condition mentioned in " Exclusion Criteria 1 for the first dose ".
- Other Participants whose physical conditions, as determined by the investigator, are not suitable for inclusion in clinical studies.
- Subjects who had vaccine-related serious adverse reactions after vaccination.
- High fever (axillary temperature > 40.0℃) lasted for two days after vaccination, or severe allergic reaction occurred.
- Any vaccine-related neurological adverse reactions occurred after vaccination.
- Participants experienced new conditions that met the "exclusion criteria for the first dose ".
- Other reasons for exclusion considered by the investigator.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Not yet recruiting
Xiangya Hospital Central South University
Changsha
Hui Xu
- Recruiting
Sichuan Center for Disease Control and Prevention
Chengdu
Xiaoping Zhu
- Recruiting
Guizhou Center for Disease Control and Prevention
Guiyang
Ruizhi Zhang
About this study
Official title: Immunogenicity and Safety of Inactivated COVID-19 Vaccine Coadministered With 23-valent Pneumococcal Polysaccharide Vaccine and Quadrivalent Influenza Vaccine in Hemodialysis Population: a Multicentre, Randomised, Controlled, Phase 4 Trial
Evaluation of immunogenicity and safety of inactivated COVID-19 vaccine (BBIBP-Corv) coadministered with PPV23 and IIV4 in hemodialysis population.
Read the detailed description
Participants aged ≥18 undergoing hemodialysis were recruited and randomly assigned to one of three study groups.
Experimental Group : The participants received the first dose of BBIBP-Corv and IIV4 simultaneously on Day 0, and received the second dose of BBIBP-Corv and PPV23 simultaneously on Day 28.
Control Group 1: The participants received two doses of BBIBP-Corv on Day 0 and Day 28, respectively.
Control Group 2 : The participants received one doses of IIV4 on Day 0 and received one doses of PPV23 on Day 28.
Three blood samples were collected on days 0, 28 and 56 to test humoral immunity, and three blood samples were collected on days 0, 42 and 56 to test cellular immunity to SARS-CoV-2.
Any local or systemic adverse events after vaccination will be recorded.
- Being tested
- coadministration, COVID-19 vaccine, IIV4+PPV23
- Medical subject headings
- Hemolysis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coadministrationBiological
the coadministration of an inactivated COVID-19 vaccine (BBIBP-CorV) and IIV4 on Day 0, and the coadministration of BBIBP-CorV and PPV23 on Day 28
COVID-19 vaccineBiological
received two doses of inactivated COVID-19 vaccine (BBIBP-CorV)
IIV4+PPV23Biological
received one dose of IIV4 on Day 0, and one dose of PPV23 on Day 28
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Total of 400 participants received one dose of BBIBP-Corv and IIV4 on Day 0, and received one dose of BBIBP-Corv and PPV23 on Day 28. Blood sampling was performed on Day 0, Day 28 and Day 56 for humoral immunity assessment.
30 of the 400 participants were selected to collect three blood samples on Day 0, Day 42 and Day 56 for cellular immune assessment. Receives: Biological: coadministration |
| Control Group 1 | Active comparator | Total of 400 participants received two doses of BBIBP-Corv on Day 0 and Day 28. Blood sampling was performed on Day 0, Day 28 and Day 56 for humoral immunity assessment.
30 of the 400 participants were selected to collect three blood samples on Day 0, Day 42 and Day 56 for cellular immune assessment. Receives: Biological: COVID-19 vaccine |
| Control Group 2 | Active comparator | Total of 400 participants received one dose IIV4 on Day 0 and received one dose PPV23 on Day 28. Blood sampling was performed on Day 0, Day 28 and Day 56 for humoral immunity assessment. Receives: Biological: IIV4+PPV23 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate against SARS-CoV-2
The rate of seroconversion against SARS-CoV-2
Measured: 28 days after two doses vaccination (Day 56)
Seroconversion rate against IIV4
The rate of seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Measured: 28 days after vaccination (Day 28)
Seroconversion rate against PPV23
The rate of seroconversion against 23 pneumococcal serotypes
Measured: 28 days after vaccination (Day 56)
Neutralizing antibody GMT against SARS-CoV-2
Neutralizing antibody GMT against SARS-CoV-2 after vaccination
Measured: 28 days after two doses vaccination (Day 56)
Hemmagglution inhibition antibody GMT against IIV4
Hemmagglution inhibition antibody GMT against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Measured: 28 days after vaccination (Day 28)
IgG antibody GMC against PPV23
IgG antibody GMC against 23 pneumococcal serotypes
Measured: 28 days after vaccination (Day 56)
Neutralizing antibody geometric mean increase (GMI) against SARS-CoV-2
Neutralizing antibody GMI against SARS-CoV-2 after vaccination
Measured: 28 days after two doses vaccination (Day 56)
Hemmagglution inhibition antibody GMI against IIV4
Hemmagglution inhibition antibody GMI against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Measured: 28 days after vaccination (Day 28)
IgG antibody GMI against PPV23
IgG antibody GMI against 23 pneumococcal serotypes
Measured: 28 days after vaccination (Day 56)
Secondary outcomes (2)
Adverse events rate
Analyse the incidence of adverse events following vaccination, both solicited and unsolicited
Measured: 0-7 days or 0-28 days following vaccinations
Serious adverse event rate
Report and analyse serious adverse events
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start5 Aug 2022
- Primary completion30 Jan 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemolysisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Biotec Group Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hunan Provincial Center for Disease Control and Prevention, Sichuan Center for Disease Control and Prevention, Guizhou Center for Disease Control and Prevention, Xiangya Hospital of Central South University, Beijing Institute of Biological Products Co Ltd., Chengdu Institute of Biological Products Co.,Ltd., Shanghai Institute Of Biological Products
- Responsible party
- Sponsor
- Investigators
- Tao Huang, Principal investigator, Hunan Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480436
- Sponsor's protocol ID
- 2022BBIBP-corv+IIV4+PPPV23
- Status last verified
- Aug 2022
- First submitted
- 27 Jul 2022
- Last updated
- 30 Aug 2022
- 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 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Inactivated COVID-19 Vaccine Coadministered With 23-valent Pneumococcal Polysaccharide Vaccine and Quadrivalent Influenza Vaccine in Hemodialysis Population: a Multicentre, Randomised, Controlled, Phase 4 Trial
- ClinicalTrials.gov ID
- NCT05480436
- Acronym / sponsor ID
- 2022BBIBP-corv+IIV4+PPPV23
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- China National Biotec Group Company LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Hunan Provincial Center for Disease Control and Prevention, Sichuan Center for Disease Control and Prevention, Guizhou Center for Disease Control and Prevention, Xiangya Hospital of Central South University, Beijing Institute of Biological Products Co Ltd., Chengdu Institute of Biological Products Co.,Ltd., Shanghai Institute Of Biological Products
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 29 Jul 2022 (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.
Evaluation of immunogenicity and safety of inactivated COVID-19 vaccine (BBIBP-Corv) coadministered with PPV23 and IIV4 in hemodialysis population.
Detailed description
Participants aged ≥18 undergoing hemodialysis were recruited and randomly assigned to one of three study groups.
Experimental Group : The participants received the first dose of BBIBP-Corv and IIV4 simultaneously on Day 0, and received the second dose of BBIBP-Corv and PPV23 simultaneously on Day 28.
Control Group 1: The participants received two doses of BBIBP-Corv on Day 0 and Day 28, respectively.
Control Group 2 : The participants received one doses of IIV4 on Day 0 and received one doses of PPV23 on Day 28.
Three blood samples were collected on days 0, 28 and 56 to test humoral immunity, and three blood samples were collected on days 0, 42 and 56 to test cellular immunity to SARS-CoV-2.
Any local or systemic adverse events after vaccination will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Biological: coadministrationTotal of 400 participants received one dose of BBIBP-Corv and IIV4 on Day 0, and received one dose of BBIBP-Corv and PPV23 on Day 28. Blood sampling was performed on Day 0, Day 28 and Day 56 for humoral immunity assessment. 30 of the 400 participants were selected to collect three blood samples on Day 0, Day 42 and Day 56 for cellular immune assessment. |
| Control Group 1 | Active comparator | Biological: COVID-19 vaccineTotal of 400 participants received two doses of BBIBP-Corv on Day 0 and Day 28. Blood sampling was performed on Day 0, Day 28 and Day 56 for humoral immunity assessment. 30 of the 400 participants were selected to collect three blood samples on Day 0, Day 42 and Day 56 for cellular immune assessment. |
| Control Group 2 | Active comparator | Biological: IIV4+PPV23Total of 400 participants received one dose IIV4 on Day 0 and received one dose PPV23 on Day 28. Blood sampling was performed on Day 0, Day 28 and Day 56 for humoral immunity assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants were hemodialysis patients aged ≥18 years.
- The duration of dialysis of the participants was ≥3 months.
- The life expectancy of participants was ≥2 years.
- Participants who have not previously been infected with SARS-CoV-2.
- Participants had not received any COVID-19 vaccine and had not received any influenza or pneumonia vaccine within 1 year.
Key exclusion criteria (24 listed)
- Being allergic to any component of vaccines and a history of severe allergic reactions to any vaccine or allergic to pollen, food and other common allergens, or a history of allergic reaction to eating eggs or using gentamicin sulfate.
- Participants with uncontrolled epilepsy or a history or family history of epilepsy, a history of Guillain-Barre syndrome, Reye syndrome, and other progressive diseases.
- Participants were confirmed to be infected with H1N1, H3N2, BY and BV influenza viruses within 6 months.
- Pregnant and lactating women.
- Participants were in the period of acute illness or acute onset of chronic disease, and the acute complication has been cured for less than two weeks.
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 |
|---|---|---|
| coadministrationthe coadministration of an inactivated COVID-19 vaccine (BBIBP-CorV) and IIV4 on Day 0, and the coadministration of BBIBP-CorV and PPV23 on Day 28 | Biological | Experimental Group |
| COVID-19 vaccinereceived two doses of inactivated COVID-19 vaccine (BBIBP-CorV) | Biological | Control Group 1 |
| IIV4+PPV23received one dose of IIV4 on Day 0, and one dose of PPV23 on Day 28 | Biological | Control Group 2 |
Primary outcome
Seroconversion rate against SARS-CoV-2
Time frame: 28 days after two doses vaccination (Day 56)
The rate of seroconversion against SARS-CoV-2
Seroconversion rate against IIV4
Time frame: 28 days after vaccination (Day 28)
The rate of seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Seroconversion rate against PPV23
Time frame: 28 days after vaccination (Day 56)
The rate of seroconversion against 23 pneumococcal serotypes
Neutralizing antibody GMT against SARS-CoV-2
Time frame: 28 days after two doses vaccination (Day 56)
Neutralizing antibody GMT against SARS-CoV-2 after vaccination
Hemmagglution inhibition antibody GMT against IIV4
Time frame: 28 days after vaccination (Day 28)
Hemmagglution inhibition antibody GMT against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
IgG antibody GMC against PPV23
Time frame: 28 days after vaccination (Day 56)
IgG antibody GMC against 23 pneumococcal serotypes
Neutralizing antibody geometric mean increase (GMI) against SARS-CoV-2
Time frame: 28 days after two doses vaccination (Day 56)
Neutralizing antibody GMI against SARS-CoV-2 after vaccination
Hemmagglution inhibition antibody GMI against IIV4
Time frame: 28 days after vaccination (Day 28)
Hemmagglution inhibition antibody GMI against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
IgG antibody GMI against PPV23
Time frame: 28 days after vaccination (Day 56)
IgG antibody GMI against 23 pneumococcal serotypes
2 secondary outcomes
Adverse events rate
Time frame: 0-7 days or 0-28 days following vaccinations
Serious adverse event rate
Time frame: 0-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- 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.
Tao Huang principal investigator
Hunan Provincial Center for Disease Control and Prevention
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 coadministration, COVID-19 vaccine and IIV4+PPV23 in people with Hemolysis and COVID-19, 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 11 inclusion and 24 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 30 Aug 2022. 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 Tao Huang (+8615084736658, ymlc01@hncdc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion rate against SARS-CoV-2 (time frame: 28 days after two doses vaccination (Day 56)). The study lists 9 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 30 Aug 2022.