RabiesPhase 4NCT05547815
Observation on the Immune Persistence of People Aged 10-60 Years Old Immunized With Five Doses of Rabies Vaccine
A Phase 4 study testing 5 doses program in people with Rabies and Antibody, run by Changchun Zhuoyi Biological Co., Ltd at 1 site in China.
Trial summary
Evaluation of immune persistence after rabies vaccination in 150 people. Read more about this study
- Who is it for?
- Ages 10 to 60 yearsHealthy volunteers can take part
- What is being tested?
- 5 doses program
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2019to 8 Nov 2021
- 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 10 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 10-60 years old；
- Temperature on the day of admission≤37.0 ° C (axillary temperature).
Who cannot join
- Have a history of rabies vaccine immunization or use of rabies virus passive immunization agents；
- Has been diagnosed with congenital or acquired immunodeficiency disease;
- Pregnancy (including positive urine pregnancy test) or lactation, planned pregnancy preparation within 2 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Arm, Single Center Phase IV Clinical Trial to Evaluate the Immune Persistence and Safety of Freeze-dried Human Rabies Vaccine (Vero Cell)
Evaluation of immune persistence after rabies vaccination in 150 people.
Read the detailed description
150 subjects aged 10-60 were recruited to inoculate the frozen human rabies vaccine (Vero cells) produced and marketed by Changchun Zhuoyi Biological Co., Ltd. in the whole process of 0, 3, 7, 14 and 28 day immunization. The immunogenicity persistence and safety of the test vaccine were evaluated 14 days, 6 months and 12 months after the whole process of vaccination.
- Being tested
- 5 doses program
- Keywords
- rabies vaccine, antibody, persistence
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 doses programBiological
Inoculate 5 doses of rabies vaccine, and collect blood at fixed time points to detect neutralizing antibody
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | 5 doses of rabies vaccine Receives: Biological: 5 doses program |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive conversion rate evaluation (6 months)
Evaluate the positive conversion rate 6 months after vaccination of rabies vaccine according to the 5-dose immunization program
Measured: 6 months
antibody titer evaluation (6 months)
Evaluate the antibody titer of serum neutralizing antibody 6 months after vaccination of rabies vaccine according to the 5-dose immunization program
Measured: 6 months
positive conversion rate evaluation (12 months)
Evaluate the positive conversion rate 12 months after vaccination of rabies vaccine according to the 5-dose immunization program
Measured: 12 months
antibody titer evaluation (12 months)
Evaluate the antibody titer of serum neutralizing antibody 12 months after vaccination of rabies vaccine according to the 5-dose immunization program
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start11 Nov 2019
- Primary completion17 Dec 2020
- Study completion8 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RabiesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changchun Zhuoyi Biological Co., Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Miao, Dr, Study director, Changchun Zhuoyi Biological Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547815
- Sponsor's protocol ID
- ZY201909001
- Status last verified
- Sep 2022
- First submitted
- 13 Sep 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all data of antibody titer .
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm, Single Center Phase IV Clinical Trial to Evaluate the Immune Persistence and Safety of Freeze-dried Human Rabies Vaccine (Vero Cell)
- ClinicalTrials.gov ID
- NCT05547815
- Acronym / sponsor ID
- ZY201909001
- Keywords
- rabies vaccine, antibody, persistence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Changchun Zhuoyi Biological Co., LtdUniversity, hospital or other
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 17 Dec 2020 (actual)
- Study completion
- 8 Nov 2021 (actual)
- First posted
- 21 Sep 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 immune persistence after rabies vaccination in 150 people.
Detailed description
150 subjects aged 10-60 were recruited to inoculate the frozen human rabies vaccine (Vero cells) produced and marketed by Changchun Zhuoyi Biological Co., Ltd. in the whole process of 0, 3, 7, 14 and 28 day immunization. The immunogenicity persistence and safety of the test vaccine were evaluated 14 days, 6 months and 12 months after the whole process of vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Biological: 5 doses program5 doses of rabies vaccine |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 10-60 years old；
- Temperature on the day of admission≤37.0 ° C (axillary temperature).
Key exclusion criteria (3 listed)
- Have a history of rabies vaccine immunization or use of rabies virus passive immunization agents；
- Has been diagnosed with congenital or acquired immunodeficiency disease;
- Pregnancy (including positive urine pregnancy test) or lactation, planned pregnancy preparation within 2 months.
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 |
|---|---|---|
| 5 doses programInoculate 5 doses of rabies vaccine, and collect blood at fixed time points to detect neutralizing antibody | Biological | experimental arm |
Primary outcome
positive conversion rate evaluation (6 months)
Time frame: 6 months
Evaluate the positive conversion rate 6 months after vaccination of rabies vaccine according to the 5-dose immunization program
antibody titer evaluation (6 months)
Time frame: 6 months
Evaluate the antibody titer of serum neutralizing antibody 6 months after vaccination of rabies vaccine according to the 5-dose immunization program
positive conversion rate evaluation (12 months)
Time frame: 12 months
Evaluate the positive conversion rate 12 months after vaccination of rabies vaccine according to the 5-dose immunization program
antibody titer evaluation (12 months)
Time frame: 12 months
Evaluate the antibody titer of serum neutralizing antibody 12 months after vaccination of rabies vaccine according to the 5-dose immunization program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: Yes. all data of antibody titer .
Related trials for Rabies
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A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried in a Population Aged 10 to 60 Years
Rabies
Active, not recruitingObservational study
Real-World Effectiveness of Zamerovimab and Mazorelvimab and Vaccine for Rabies Grade III Exposure in Nanyang
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Real World Evidence Study of SYN023 in Children Exposed to Rabies
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Enrolling by invitationPhase 3
A Phase III Clinical Trial on Immunogenicity and Safety of Lyophilized Rabies Vaccine for Human Use (Human Diploid Cell)
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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.
Li Miao, Dr study director
Changchun Zhuoyi Biological Co., Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 5 doses program in people with Rabies and Antibody, run by Changchun Zhuoyi Biological Co., Ltd at 1 site 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive conversion rate evaluation (6 months) (time frame: 6 months). The study lists 4 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 21 Sep 2022.