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

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

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

Study Overview

• Status: Recruiting
• Conditions: COVID-19; Rabies
• Intervention / Treatment: Biological: coadministration; Biological: COVID-19 vaccine; Biological: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 360
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ruizhi Zhang; Phone Number: +8613985441115; Email: 919987774@qq.com

Study Locations

• China
  • Guiyang, China
    • Recruiting
    • Guizhou Provincial Center for Disease Control and Prevention
    • Contact: Ruizhi Zhang
  • Taiyuan, China
    • Recruiting
    • Shanxi Provincial Center for Disease Control and Prevention
    • Contact: Shaoying Chang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Co-Ad 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.	Biological: coadministration; the coadministration of an inactivated COVID-19 vaccine (BBIBP-CorV) and rabies vaccine
EXPERIMENTAL: COVID-19 vaccine group; 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; received one dose of inactivated COVID-19 vaccine (BBIBP-CorV)
EXPERIMENTAL: Rabies vaccine group; 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; received three dose of rabies vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious adverse event rate	Report and analyse serious adverse events	0-6 months
Adverse events rate	Analyse the incidence of adverse events following vaccination, both solicited and unsolicited	0-7 days or 0-28 days following vaccinations

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 21, 2022
• Primary Completion (ANTICIPATED): October 30, 2022
• Study Completion (ANTICIPATED): June 30, 2023

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 4, 2022
• First Posted (ACTUAL): July 12, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Mononegavirales Infections; Rhabdoviridae Infections; Rabies; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: BBIBP-Cov+Rabies

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No