Evaluation of immunogenicity and safety of inactivated COVID-19 vaccine (BBIBP-Cov) coadministered with rabies vaccine.
The participants aged ≥18 who had received two doses of inactivated COVID-19 vaccine were recruited and randomly assigned to one of three study groups: Co-Ad group, COVID-19 vaccine group and Rabies vaccine group. The participants in Co-Ad group and COVID-19 vaccine group received a booster dose of inactivated COVID-19 vaccine.The participants in Co-Ad group and Rabies vaccine group received three doses of rabies vaccine for pre-exposure immunization. The participants in Co-Ad group received the first dose of rabies vaccine (Day 0) and the inactivated COVID-19 vaccine simultaneously. Any local or systemic adverse events after vaccination will be recorded.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
360
the coadministration of an inactivated COVID-19 vaccine (BBIBP-CorV) and rabies vaccine
received one dose of inactivated COVID-19 vaccine (BBIBP-CorV)
received three dose of rabies vaccine
Guizhou Provincial Center for Disease Control and Prevention
Guiyang, China
RECRUITINGShanxi Provincial Center for Disease Control and Prevention
Taiyuan, China
RECRUITINGSeroconversion rate against SARS-CoV-2
The rate of seroconversion against SARS-CoV-2
Time frame: 28 days after vaccination (Day 28)
Seroconversion rate against rabies virus
The rate of seroconversion against rabies virus
Time frame: 14 days after the 3th dose (Day 42)
Neutralizing antibody GMT against SARS-CoV-2
Neutralizing antibody GMT against SARS-CoV-2 after vaccination
Time frame: 28 days after vaccination (Day 28)
Neutralizing antibody GMC against rabies virus
Neutralizing antibody GMC against rabies virus after 3th dose
Time frame: 14 days after the 3th dose (Day 42)
Neutralizing antibody GMI against SARS-CoV-2
Neutralizing antibody GMI against SARS-CoV-2 after vaccination
Time frame: 28 days after vaccination (Day 28)
Neutralizing antibody GMI against rabies virus
Neutralizing antibody GMI against rabies virus after 3th dose
Time frame: 14 days after the 3th dose (Day 42)
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
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Time frame: 0-6 months