Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine (Sinopharm BBIBP-CorV) Coadministered With Rabies Vaccine

NCT05453487 | Unknown Phase 4

• 1 other identifier: BBIBP-Cov+Rabies
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

COVID-19; Rabies

Outcome Measures

Primary Outcomes (6)

• Seroconversion rate against SARS-CoV-2

  The rate of seroconversion against SARS-CoV-2

  28 days after vaccination (Day 28)

• Seroconversion rate against rabies virus

  The rate of seroconversion against rabies virus

  14 days after the 3th dose (Day 42)

• Neutralizing antibody GMT against SARS-CoV-2

  Neutralizing antibody GMT against SARS-CoV-2 after vaccination

  28 days after vaccination (Day 28)

• Neutralizing antibody GMC against rabies virus

  Neutralizing antibody GMC against rabies virus after 3th dose

  14 days after the 3th dose (Day 42)

• Neutralizing antibody GMI against SARS-CoV-2

  Neutralizing antibody GMI against SARS-CoV-2 after vaccination

  28 days after vaccination (Day 28)

• Neutralizing antibody GMI against rabies virus

  Neutralizing antibody GMI against rabies virus after 3th dose

  14 days after the 3th dose (Day 42)

Secondary Outcomes (2)

• Adverse events rate

  0-7 days or 0-28 days following vaccinations

• Serious adverse event rate

  0-6 months

Study Arms (3)

Co-Ad group

EXPERIMENTAL

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.

Biological: coadministration

COVID-19 vaccine group

EXPERIMENTAL

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.

Biological: COVID-19 vaccine

Rabies vaccine group

EXPERIMENTAL

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.

Biological: rabies vaccine

Interventions

coadministration BIOLOGICAL

the coadministration of an inactivated COVID-19 vaccine (BBIBP-CorV) and rabies vaccine

Co-Ad group

COVID-19 vaccine BIOLOGICAL

received one dose of inactivated COVID-19 vaccine (BBIBP-CorV)

COVID-19 vaccine group

rabies vaccine BIOLOGICAL

received three dose of rabies vaccine

Rabies vaccine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.
• Participants who had vaccine-related serious adverse reactions after vaccination.
• Systemic adverse reactions/anaphylaxis with severity ≥3 after vaccination as determined by the investigator.

Sponsors & Collaborators

• China National Biotec Group Company Limited: lead
• Guizhou Center for Disease Control and Prevention: collaborator
• Shaanxi Provincial Center for Disease Control and Prevention: collaborator
• Beijing Institute of Biological Products Co Ltd.: collaborator
• Changchun Institute of Biological Products Co., Ltd.: collaborator

Study Sites (2)

Guizhou Provincial Center for Disease Control and Prevention

Guiyang, China

RECRUITING

Shanxi Provincial Center for Disease Control and Prevention

Taiyuan, China

RECRUITING

MeSH Terms

Conditions

COVID-19; Rabies

Interventions

COVID-19 Vaccines; Rabies Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Rhabdoviridae Infections; Mononegavirales Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Ruizhi Zhang

  Guizhou Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruizhi Zhang

CONTACT

+8613985441115; 919987774@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 12, 2022
• Study Start: July 21, 2022
• Primary Completion: October 30, 2022
• Study Completion: June 30, 2023
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)