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.
Biological: coadministration
the coadministration of an inactivated COVID-19 vaccine (BBIBP-CorV) and rabies vaccine
Biological: COVID-19 vaccine
received one dose of inactivated COVID-19 vaccine (BBIBP-CorV)
Biological: rabies vaccine
received three dose of rabies vaccine
Inclusion Criteria:
- Participants aged ≥18.
- Have the ability to understand the study procedures, voluntarily sign informed
consent.
- Be able and willing to complete the entire study plan during the study follow-up
period.
- Participants have not received any rabies vaccine.
- Participants have received 2 doses of inactivated COVID-19 vaccine for 6-12 months.
- The time interval between the last vaccination is ≥14 days.
- Body temperature < 37.3 °C confirmed by clinical examination before enrollment .
Exclusion Criteria for the first dose:
- Participants who have received the third dose of COVID-19 vaccine.
- Participants who have previously been infected with COVID-19 or who have tested
positive for SARS-CoV-2.
- Having a history or family history of convulsions, epilepsy, encephalopathy and
psychosis.
- Being allergic to any component of vaccines and a history of severe allergic
reactions to any vaccine.
- Participants are suffering from immunodeficiency, receiving immunosuppressant
therapy (oral steroid hormones) during treatment for malignancy, or having low
immunity due to HIV within 14 days before enrollment, or having congenital immune
disorders in close family members.
- Injection of non-specific immunoglobulin within 1 month before enrollment.
- Participants are suffering from acute febrile diseases and infectious diseases, or
have used anti-inflammatory/antiviral/antipyretic/antiallergic drugs within 3 days
before enrollment.
- A history of clearly diagnosed thrombocytopenia or other clotting disorders that may
contraindicate subcutaneous injection.
- Participants with severe chronic diseases or acute episodes of chronic diseases,
hypertension or diabetes that cannot be controlled by drugs.
- Participants with infectious, suppurative and allergic skin diseases.
- Pregnant and lactating women.
- Other Participants whose physical conditions, as determined by the investigator, are
not suitable for inclusion in clinical studies.
Exclusion criteria for the second or third dose:
- Participants who had vaccine-related serious adverse reactions after vaccination.
- Systemic adverse reactions/anaphylaxis with severity ≥3 after vaccination as
determined by the investigator.
- Participants experienced new conditions that met the "exclusion criteria for the
first dose ".
- Other reasons for exclusion considered by the investigator.
Guizhou Provincial Center for Disease Control and Prevention
Guiyang, China
Shanxi Provincial Center for Disease Control and Prevention
Taiyuan, China
Ruizhi Zhang
+8613985441115
919987774@qq.com
Ruizhi Zhang, Principal Investigator
Guizhou provincial center for disease control and prevention