Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine (Sinopharm BBIBP-CorV) Coadministered With Rabies Vaccine
COVID-19, Rabies
About this trial
This is an interventional prevention trial for COVID-19
Eligibility Criteria
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.
Sites / Locations
- Guizhou Provincial Center for Disease Control and PreventionRecruiting
- Shanxi Provincial Center for Disease Control and PreventionRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Co-Ad group
COVID-19 vaccine group
Rabies vaccine group
A total of 120 participants received one dose of inactivated COVID-19 vaccine and three doses of rabies vaccine. Participants received one dose of inactivated COVID-19 vaccine and rabies vaccine on Day 0, and one dose of rabies vaccine on Day 7 and Day 28. Blood sampling was performed on Day 0, Day 28 and Day 42.
A total of 120 participants received one dose of inactivated COVID-19 vaccine on Day 0. Blood sampling was performed on Day 0 and Day 28.
A total of 120 participants received three doses of rabies vaccine on Day 0, Day 7 and Day 28. Blood sampling was performed on Day 0 and Day 42.