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UNKNOWNPHASE4

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

NCT05480436•China National Biotec Group Company Limited

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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.
+12 more criteria

Locations (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

Key Dates

Start Date

August 5, 2022

Primary Completion Date

January 30, 2023

Completion Date

July 30, 2023

Last Updated

August 30, 2022

Enrollment

1,200

ESTIMATED participants

Conditions

HemolysisCOVID-19

Interventions

coadministration

BIOLOGICAL

COVID-19 vaccine

BIOLOGICAL

IIV4+PPV23

BIOLOGICAL

Contacts

Tao Huang

CONTACT

+8615084736658 ymlc01@hncdc.com

Hui Xu

CONTACT

+8615974199189 1196824139@qq.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 30, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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