Clinical trial NCT05453487: Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine (Sinopharm BBIBP-CorV) Coadministered With Rabies Vaccine
Official title: Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine (Sinopharm BBIBP-CorV) Coadministered With Rabies Vaccine in China: a Multicentre, Randomised, Controlled, Phase 4 Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: COVID-19
Rabies
Lead sponsor: China National Biotec Group Company Limited
Sponsor class: INDUSTRY
Collaborators: name: Guizhou Center for Disease Control and Prevention
name: Shaanxi Provincial Center for Disease Control and Prevention
name: Beijing Institute of Biological Products Co Ltd.
name: Changchun Institute of Biological Products Co., Ltd.
First posted: 2022-07-12
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluation of immunogenicity and safety of inactivated COVID-19 vaccine (BBIBP-Cov) coadministered with rabies vaccine.

Detailed description: 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.

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.

Primary outcomes:
measure: Seroconversion rate against SARS-CoV-2
timeFrame: 28 days after vaccination (Day 28)
measure: Seroconversion rate against rabies virus
timeFrame: 14 days after the 3th dose (Day 42)
measure: Neutralizing antibody GMT against SARS-CoV-2
timeFrame: 28 days after vaccination (Day 28)
measure: Neutralizing antibody GMC against rabies virus
timeFrame: 14 days after the 3th dose (Day 42)
measure: Neutralizing antibody GMI against SARS-CoV-2
timeFrame: 28 days after vaccination (Day 28)
measure: Neutralizing antibody GMI against rabies virus
timeFrame: 14 days after the 3th dose (Day 42)
Secondary outcomes:
measure: Adverse events rate
timeFrame: 0-7 days or 0-28 days following vaccinations
measure: Serious adverse event rate
timeFrame: 0-6 months
Other outcomes:
Locations:
city: Guiyang
country: China
facility: Guizhou Provincial Center for Disease Control and Prevention
city: Taiyuan
country: China
facility: Shanxi Provincial Center for Disease Control and Prevention
Study officials:
affiliation: Guizhou provincial center for disease control and prevention
name: Ruizhi Zhang
role: PRINCIPAL_INVESTIGATOR
References: