Immunogenicity and Safety of BBIBP-Corv Coadministered With PPV23 and IIV4 in Hemodialysis Population
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
1 other identifier
interventional
1,200
1 country
3
Brief Summary
Evaluation of immunogenicity and safety of inactivated COVID-19 vaccine (BBIBP-Corv) coadministered with PPV23 and IIV4 in hemodialysis population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2022
Shorter than P25 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2022
CompletedFirst Posted
Study publicly available on registry
July 29, 2022
CompletedStudy Start
First participant enrolled
August 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2023
CompletedAugust 30, 2022
August 1, 2022
6 months
July 27, 2022
August 28, 2022
Conditions
Outcome Measures
Primary Outcomes (9)
Seroconversion rate against SARS-CoV-2
The rate of seroconversion against SARS-CoV-2
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
28 days after vaccination (Day 28)
Seroconversion rate against PPV23
The rate of seroconversion against 23 pneumococcal serotypes
28 days after vaccination (Day 56)
Neutralizing antibody GMT against SARS-CoV-2
Neutralizing antibody GMT against SARS-CoV-2 after vaccination
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
28 days after vaccination (Day 28)
IgG antibody GMC against PPV23
IgG antibody GMC against 23 pneumococcal serotypes
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
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
28 days after vaccination (Day 28)
IgG antibody GMI against PPV23
IgG antibody GMI against 23 pneumococcal serotypes
28 days after vaccination (Day 56)
Secondary Outcomes (2)
Adverse events rate
0-7 days or 0-28 days following vaccinations
Serious adverse event rate
0-6 months
Study Arms (3)
Experimental Group
EXPERIMENTALTotal 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 COMPARATORTotal 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 COMPARATORTotal 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.
Interventions
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
received two doses of inactivated COVID-19 vaccine (BBIBP-CorV)
received one dose of IIV4 on Day 0, and one dose of PPV23 on Day 28
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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).
- 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.).
- Participants who need medical intervention (except blood glucose) after laboratory tests (blood routine, blood biochemical, coagulation routine) are judged by the investigator.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- China National Biotec Group Company Limitedlead
- Hunan Provincial Center for Disease Control and Preventioncollaborator
- Sichuan Center for Disease Control and Preventioncollaborator
- Guizhou Center for Disease Control and Preventioncollaborator
- Xiangya Hospital of Central South Universitycollaborator
- Beijing Institute of Biological Products Co Ltd.collaborator
- Chengdu Institute of Biological Products Co.,Ltd.collaborator
- Shanghai Institute Of Biological Productscollaborator
Study Sites (3)
Xiangya Hospital Central South University
Changsha, China
Sichuan Center for Disease Control and Prevention
Chengdu, China
Guizhou Center for Disease Control and Prevention
Guiyang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tao Huang
Hunan Provincial Center for Disease Control and Prevention
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2022
First Posted
July 29, 2022
Study Start
August 5, 2022
Primary Completion
January 30, 2023
Study Completion
July 30, 2023
Last Updated
August 30, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share