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

  • STATUS
    Recruiting
  • End date
    Jul 30, 2023
  • participants needed
    1200
  • sponsor
    China National Biotec Group Company Limited
Updated on 7 October 2022

Summary

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

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.

Details
Condition Hemolysis, COVID-19
Treatment covid-19 vaccine, coadministration, IIV4+PPV23
Clinical Study IdentifierNCT05480436
SponsorChina National Biotec Group Company Limited
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
Inclusion Criteria 2
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
Exclusion Criteria 2 for the first dose
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
Exclusion criteria for the second dose
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
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