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

Phase 4

• Conditions: Hemolysis; COVID-19
• Interventions: Biological: coadministration; Biological: COVID-19 vaccine; Biological: IIV4+PPV23

• Registration Number: NCT05480436
• Lead Sponsor: China National Biotec Group Company Limited

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.

Study Timeline

• Study First Submitted: 2022-07-27
• Study First Submitted QC: 2022-07-27
• Study First Posted: 2022-07-29
• Status Verified: 2022-08
• Study Start: 2022-08-05
• Last Update Submitted: 2022-08-28
• Last Update Posted: 2022-08-30
• Primary Completion: 2023-01-30
• Study Completion: 2023-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	coadministration	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.
Control Group 1	COVID-19 vaccine	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.
Control Group 2	IIV4+PPV23	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.

Primary Outcome Measures

Name	Time	Method
Seroconversion rate against IIV4	28 days after vaccination (Day 28)	The rate of seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Seroconversion rate against PPV23	28 days after vaccination (Day 56)	The rate of seroconversion against 23 pneumococcal serotypes
Neutralizing antibody GMT against SARS-CoV-2	28 days after two doses vaccination (Day 56)	Neutralizing antibody GMT against SARS-CoV-2 after vaccination
Hemmagglution inhibition antibody GMT against IIV4	28 days after vaccination (Day 28)	Hemmagglution inhibition antibody GMT against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
IgG antibody GMC against PPV23	28 days after vaccination (Day 56)	IgG antibody GMC against 23 pneumococcal serotypes
Neutralizing antibody geometric mean increase (GMI) against SARS-CoV-2	28 days after two doses vaccination (Day 56)	Neutralizing antibody GMI against SARS-CoV-2 after vaccination
Hemmagglution inhibition antibody GMI against IIV4	28 days after vaccination (Day 28)	Hemmagglution inhibition antibody GMI against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
IgG antibody GMI against PPV23	28 days after vaccination (Day 56)	IgG antibody GMI against 23 pneumococcal serotypes
Seroconversion rate against SARS-CoV-2	28 days after two doses vaccination (Day 56)	The rate of seroconversion against SARS-CoV-2

Secondary Outcome Measures

Name	Time	Method
Adverse events rate	0-7 days or 0-28 days following vaccinations	Analyse the incidence of adverse events following vaccination, both solicited and unsolicited
Serious adverse event rate	0-6 months	Report and analyse serious adverse events

Trial Locations

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