COVID-19Phase 4NCT05453487
Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine (Sinopharm BBIBP-CorV) Coadministered With Rabies Vaccine
A Phase 4 study testing coadministration, COVID-19 vaccine and rabies vaccine in people with COVID-19 and Rabies, run by China National Biotec Group Company Limited at 2 sites in China.
Trial summary
Evaluation of immunogenicity and safety of inactivated COVID-19 vaccine (BBIBP-Cov) coadministered with rabies vaccine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- coadministration, COVID-19 vaccine and rabies vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 2 sitesChina
- Study dates
- 21 Jul 2022to 30 Jun 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- 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.
Show all 16Show fewer
- 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.
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Guizhou Provincial Center for Disease Control and Prevention
Guiyang
Ruizhi Zhang
- Recruiting
Shanxi Provincial Center for Disease Control and Prevention
Taiyuan
Shaoying Chang
About this study
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
Evaluation of immunogenicity and safety of inactivated COVID-19 vaccine (BBIBP-Cov) coadministered with rabies vaccine.
Read the 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.
- Being tested
- coadministration, COVID-19 vaccine, rabies vaccine
- Medical subject headings
- COVID-19, Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coadministrationBiological
the coadministration of an inactivated COVID-19 vaccine (BBIBP-CorV) and rabies vaccine
COVID-19 vaccineBiological
received one dose of inactivated COVID-19 vaccine (BBIBP-CorV)
rabies vaccineBiological
received three dose of rabies vaccine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Biological: rabies vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate against SARS-CoV-2
The rate of seroconversion against SARS-CoV-2
Measured: 28 days after vaccination (Day 28)
Seroconversion rate against rabies virus
The rate of seroconversion against rabies virus
Measured: 14 days after the 3th dose (Day 42)
Neutralizing antibody GMT against SARS-CoV-2
Neutralizing antibody GMT against SARS-CoV-2 after vaccination
Measured: 28 days after vaccination (Day 28)
Neutralizing antibody GMC against rabies virus
Neutralizing antibody GMC against rabies virus after 3th dose
Measured: 14 days after the 3th dose (Day 42)
Neutralizing antibody GMI against SARS-CoV-2
Neutralizing antibody GMI against SARS-CoV-2 after vaccination
Measured: 28 days after vaccination (Day 28)
Neutralizing antibody GMI against rabies virus
Neutralizing antibody GMI against rabies virus after 3th dose
Measured: 14 days after the 3th dose (Day 42)
Secondary outcomes (2)
Adverse events rate
Analyse the incidence of adverse events following vaccination, both solicited and unsolicited
Measured: 0-7 days or 0-28 days following vaccinations
Serious adverse event rate
Report and analyse serious adverse events
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start21 Jul 2022
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Biotec Group Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- 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.
- Responsible party
- Sponsor
- Investigators
- Ruizhi Zhang, Principal investigator, Guizhou Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453487
- Sponsor's protocol ID
- BBIBP-Cov+Rabies
- Status last verified
- Jul 2022
- First submitted
- 4 Jul 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05453487
- Acronym / sponsor ID
- BBIBP-Cov+Rabies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- China National Biotec Group Company LimitedIndustry (pharma, biotech, devices)
- 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.
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Co-Ad group | Experimental | Biological: coadministrationA 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. |
| COVID-19 vaccine group | Experimental | Biological: COVID-19 vaccineA 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. |
| Rabies vaccine group | Experimental | Biological: rabies vaccineA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coadministrationthe coadministration of an inactivated COVID-19 vaccine (BBIBP-CorV) and rabies vaccine | Biological | Co-Ad group |
| COVID-19 vaccinereceived one dose of inactivated COVID-19 vaccine (BBIBP-CorV) | Biological | COVID-19 vaccine group |
| rabies vaccinereceived three dose of rabies vaccine | Biological | Rabies vaccine group |
Primary outcome
Seroconversion rate against SARS-CoV-2
Time frame: 28 days after vaccination (Day 28)
The rate of seroconversion against SARS-CoV-2
Seroconversion rate against rabies virus
Time frame: 14 days after the 3th dose (Day 42)
The rate of seroconversion against rabies virus
Neutralizing antibody GMT against SARS-CoV-2
Time frame: 28 days after vaccination (Day 28)
Neutralizing antibody GMT against SARS-CoV-2 after vaccination
Neutralizing antibody GMC against rabies virus
Time frame: 14 days after the 3th dose (Day 42)
Neutralizing antibody GMC against rabies virus after 3th dose
Neutralizing antibody GMI against SARS-CoV-2
Time frame: 28 days after vaccination (Day 28)
Neutralizing antibody GMI against SARS-CoV-2 after vaccination
Neutralizing antibody GMI against rabies virus
Time frame: 14 days after the 3th dose (Day 42)
Neutralizing antibody GMI against rabies virus after 3th dose
2 secondary outcomes
Adverse events rate
Time frame: 0-7 days or 0-28 days following vaccinations
Serious adverse event rate
Time frame: 0-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruizhi Zhang principal investigator
Guizhou Provincial Center for Disease Control and Prevention
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing coadministration, COVID-19 vaccine and rabies vaccine in people with COVID-19 and Rabies, run by China National Biotec Group Company Limited at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruizhi Zhang (+8613985441115, 919987774@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion rate against SARS-CoV-2 (time frame: 28 days after vaccination (Day 28)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.