Immunogenicity and Safety of BBIBP-Corv Coadministered With PPV23 and IIV4 in Hemodialysis Population

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-05

Study Completion Date

2023-07-30

Brief Summary

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Evaluation of immunogenicity and safety of inactivated COVID-19 vaccine (BBIBP-Corv) coadministered with PPV23 and IIV4 in hemodialysis population.

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Detailed Description

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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.

Conditions

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Hemolysis COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Experimental Group

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.

Group Type EXPERIMENTAL

coadministration

Intervention Type BIOLOGICAL

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

Control Group 1

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.

Group Type ACTIVE_COMPARATOR

COVID-19 vaccine

Intervention Type BIOLOGICAL

received two doses of inactivated COVID-19 vaccine (BBIBP-CorV)

Control Group 2

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.

Group Type ACTIVE_COMPARATOR

IIV4+PPV23

Intervention Type BIOLOGICAL

received one dose of IIV4 on Day 0, and one dose of PPV23 on Day 28

Interventions

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coadministration

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

Intervention Type BIOLOGICAL

COVID-19 vaccine

received two doses of inactivated COVID-19 vaccine (BBIBP-CorV)

Intervention Type BIOLOGICAL

IIV4+PPV23

received one dose of IIV4 on Day 0, and one dose of PPV23 on Day 28

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.).
* 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
* 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.
* Other reasons for exclusion considered by the investigator.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No