Clinical trial NCT05480436: Immunogenicity and Safety of BBIBP-Corv Coadministered With PPV23 and IIV4 in Hemodialysis Population
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hemolysis
COVID-19
Lead sponsor: China National Biotec Group Company Limited
Sponsor class: INDUSTRY
Collaborators: name: Hunan Provincial Center for Disease Control and Prevention
name: Sichuan Center for Disease Control and Prevention
name: Guizhou Center for Disease Control and Prevention
name: Xiangya Hospital of Central South University
name: Beijing Institute of Biological Products Co Ltd.
name: Chengdu Institute of Biological Products Co.,Ltd.
name: Shanghai Institute Of Biological Products
First posted: 2022-07-29
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 criteria: Inclusion Criteria 1 :

* 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 1 for the first dose:

* 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.

Primary outcomes:
measure: Seroconversion rate against SARS-CoV-2
timeFrame: 28 days after two doses vaccination (Day 56)
measure: Seroconversion rate against IIV4
timeFrame: 28 days after vaccination (Day 28)
measure: Seroconversion rate against PPV23
timeFrame: 28 days after vaccination (Day 56)
measure: Neutralizing antibody GMT against SARS-CoV-2
timeFrame: 28 days after two doses vaccination (Day 56)
measure: Hemmagglution inhibition antibody GMT against IIV4
timeFrame: 28 days after vaccination (Day 28)
measure: IgG antibody GMC against PPV23
timeFrame: 28 days after vaccination (Day 56)
measure: Neutralizing antibody geometric mean increase (GMI) against SARS-CoV-2
timeFrame: 28 days after two doses vaccination (Day 56)
measure: Hemmagglution inhibition antibody GMI against IIV4
timeFrame: 28 days after vaccination (Day 28)
measure: IgG antibody GMI against PPV23
timeFrame: 28 days after vaccination (Day 56)
Secondary outcomes:
measure: Adverse events rate
timeFrame: 0-7 days or 0-28 days following vaccinations
measure: Serious adverse event rate
timeFrame: 0-6 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: Chengdu
country: China
facility: Sichuan Center for Disease Control and Prevention
city: Guiyang
country: China
facility: Guizhou Center for Disease Control and Prevention
Study officials:
affiliation: Hunan Provincial Center for Disease Control and Prevention
name: Tao Huang
role: PRINCIPAL_INVESTIGATOR
References: