Evaluation of immunogenicity and safety of inactivated COVID-19 vaccine (BBIBP-Corv) coadministered with PPV23 and IIV4 in hemodialysis population.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,200
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
received two doses of inactivated COVID-19 vaccine (BBIBP-CorV)
received one dose of IIV4 on Day 0, and one dose of PPV23 on Day 28
Xiangya Hospital Central South University
Changsha, China
NOT_YET_RECRUITINGSichuan Center for Disease Control and Prevention
Chengdu, China
RECRUITINGGuizhou Center for Disease Control and Prevention
Guiyang, China
RECRUITINGSeroconversion rate against SARS-CoV-2
The rate of seroconversion against SARS-CoV-2
Time frame: 28 days after two doses vaccination (Day 56)
Seroconversion rate against IIV4
The rate of seroconversion against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Time frame: 28 days after vaccination (Day 28)
Seroconversion rate against PPV23
The rate of seroconversion against 23 pneumococcal serotypes
Time frame: 28 days after vaccination (Day 56)
Neutralizing antibody GMT against SARS-CoV-2
Neutralizing antibody GMT against SARS-CoV-2 after vaccination
Time frame: 28 days after two doses vaccination (Day 56)
Hemmagglution inhibition antibody GMT against IIV4
Hemmagglution inhibition antibody GMT against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
Time frame: 28 days after vaccination (Day 28)
IgG antibody GMC against PPV23
IgG antibody GMC against 23 pneumococcal serotypes
Time frame: 28 days after vaccination (Day 56)
Neutralizing antibody geometric mean increase (GMI) against SARS-CoV-2
Neutralizing antibody GMI against SARS-CoV-2 after vaccination
Time frame: 28 days after two doses vaccination (Day 56)
Hemmagglution inhibition antibody GMI against IIV4
Hemmagglution inhibition antibody GMI against influenza A (H3N2, H1N1) type and B (BY, BV) type viruses
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Time frame: 28 days after vaccination (Day 28)
IgG antibody GMI against PPV23
IgG antibody GMI against 23 pneumococcal serotypes
Time frame: 28 days after vaccination (Day 56)
Adverse events rate
Analyse the incidence of adverse events following vaccination, both solicited and unsolicited
Time frame: 0-7 days or 0-28 days following vaccinations
Serious adverse event rate
Report and analyse serious adverse events
Time frame: 0-6 months