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

Primary Purpose

COVID-19, Rabies

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
coadministration
COVID-19 vaccine
rabies vaccine
Sponsored by
China National Biotec Group Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Arm Type

Experimental

Experimental

Experimental

Arm Label

Co-Ad group

COVID-19 vaccine group

Rabies vaccine group

Arm Description

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.

Outcomes

Primary Outcome Measures

Seroconversion rate against SARS-CoV-2
The rate of seroconversion against SARS-CoV-2
Seroconversion rate against rabies virus
The rate of seroconversion against rabies virus
Neutralizing antibody GMT against SARS-CoV-2
Neutralizing antibody GMT against SARS-CoV-2 after vaccination
Neutralizing antibody GMC against rabies virus
Neutralizing antibody GMC against rabies virus after 3th dose
Neutralizing antibody GMI against SARS-CoV-2
Neutralizing antibody GMI against SARS-CoV-2 after vaccination
Neutralizing antibody GMI against rabies virus
Neutralizing antibody GMI against rabies virus after 3th dose

Secondary Outcome Measures

Adverse events rate
Analyse the incidence of adverse events following vaccination, both solicited and unsolicited
Serious adverse event rate
Report and analyse serious adverse events

Full Information

First Posted
July 4, 2022
Last Updated
July 27, 2022
Sponsor
China National Biotec Group Company Limited
Collaborators
Guizhou Center for Disease Control and Prevention, Shaanxi Provincial Center for Disease Control and Prevention, Beijing Institute of Biological Products Co Ltd., Changchun Institute of Biological Products Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05453487
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2022 (Actual)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Biotec Group Company Limited
Collaborators
Guizhou Center for Disease Control and Prevention, Shaanxi Provincial Center for Disease Control and Prevention, Beijing Institute of Biological Products Co Ltd., Changchun Institute of Biological Products Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Rabies

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Co-Ad group
Arm Type
Experimental
Arm Description
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.
Arm Title
COVID-19 vaccine group
Arm Type
Experimental
Arm Description
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.
Arm Title
Rabies vaccine group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
coadministration
Intervention Description
the coadministration of an inactivated COVID-19 vaccine (BBIBP-CorV) and rabies vaccine
Intervention Type
Biological
Intervention Name(s)
COVID-19 vaccine
Intervention Description
received one dose of inactivated COVID-19 vaccine (BBIBP-CorV)
Intervention Type
Biological
Intervention Name(s)
rabies vaccine
Intervention Description
received three dose of rabies vaccine
Primary Outcome Measure Information:
Title
Seroconversion rate against SARS-CoV-2
Description
The rate of seroconversion against SARS-CoV-2
Time Frame
28 days after vaccination (Day 28)
Title
Seroconversion rate against rabies virus
Description
The rate of seroconversion against rabies virus
Time Frame
14 days after the 3th dose (Day 42)
Title
Neutralizing antibody GMT against SARS-CoV-2
Description
Neutralizing antibody GMT against SARS-CoV-2 after vaccination
Time Frame
28 days after vaccination (Day 28)
Title
Neutralizing antibody GMC against rabies virus
Description
Neutralizing antibody GMC against rabies virus after 3th dose
Time Frame
14 days after the 3th dose (Day 42)
Title
Neutralizing antibody GMI against SARS-CoV-2
Description
Neutralizing antibody GMI against SARS-CoV-2 after vaccination
Time Frame
28 days after vaccination (Day 28)
Title
Neutralizing antibody GMI against rabies virus
Description
Neutralizing antibody GMI against rabies virus after 3th dose
Time Frame
14 days after the 3th dose (Day 42)
Secondary Outcome Measure Information:
Title
Adverse events rate
Description
Analyse the incidence of adverse events following vaccination, both solicited and unsolicited
Time Frame
0-7 days or 0-28 days following vaccinations
Title
Serious adverse event rate
Description
Report and analyse serious adverse events
Time Frame
0-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruizhi Zhang
Phone
+8613985441115
Email
919987774@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruizhi Zhang
Organizational Affiliation
Guizhou provincial center for disease control and prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guizhou Provincial Center for Disease Control and Prevention
City
Guiyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruizhi Zhang
Facility Name
Shanxi Provincial Center for Disease Control and Prevention
City
Taiyuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaoying Chang

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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