Rabies HumanPhase 3NCT05549908
Vaccine Prevention of Rabies Adopts 4-shot Immunization Method
A Phase 3 study testing rabies vaccine in people with Rabies Human and Antibody Titer, run by Changchun Zhuoyi Biological Co., Ltd at 1 site in China.
Trial summary
A phase III clinical trial to evaluate the immunogenicity and safety of freeze-dried human rabies vaccine (Vero cell) developed by Changchun Zhuoyi Biological Co., Ltd. inoculated in a 4-dose procedure (2-1-1) Read more about this study
- Who is it for?
- Ages 10 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies Human, Antibody Titer
- What is being tested?
- rabies vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteChina
- Study dates
- 22 Jul 2020to 20 Apr 2023
- Phase
- Phase 3
- 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
- The age is 10-60 years old;
- Underarm temperature ≤ 37.0 ℃.
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: Randomized, Blind, Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Freeze-dried Human Rabies Vaccine (Vero Cell) Inoculated in 4-dose Program (2-1-1)
A phase III clinical trial to evaluate the immunogenicity and safety of freeze-dried human rabies vaccine (Vero cell) developed by Changchun Zhuoyi Biological Co., Ltd. inoculated in a 4-dose procedure (2-1-1)
Read the detailed description
It is to prove that the freeze-dried human rabies vaccine (Vero cell) in the population aged 10-60 years, the four dose vaccination program is not inferior to the five dose vaccination program, and the safty、antibody positive conversion rate and geometric mean concentration of the four dose group of the test vaccine are not inferior to the five dose program group 14 days after the first dose vaccination.
To compare the immunogenicity of people aged 10-60 years old who were vaccinated 6 and 12 months after the whole vaccination, so as to evaluate the antibody positive rate and GMT 6 and 12 months after the test vaccine was vaccinated.
- Conditions
- Rabies Human, Antibody Titer
- Being tested
- rabies vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rabies vaccineBiological
The subjects were vaccinated with rabies vaccines with different immunization procedures, and the safety and immunogenicity were compared
| Study group | Role | What they receive |
|---|---|---|
| Experimental 4 doses | Experimental | Inoculate experimental vaccine according to 2-1-1 immunization procedure Receives: Biological: rabies vaccine |
| Experimental 5 doses | Experimental | Inoculate experimental vaccine according to 1-1-1-1-1 immunization procedure Receives: Biological: rabies vaccine |
| SPEEDA® 4 doses | Active comparator | Inoculate SPEEDA® according to 2-1-1 immunization procedure Receives: Biological: rabies vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody positive conversion rate of experimental groups
- Compare the Antibody positive conversion rate between two experimental groups 14 days after the first dose of inoculation.
Measured: 3 months
Antibody positive conversion rate of 4 doses groups
-Compare the Antibody positive conversion rate between the SPEEDA 4 doses group and experimental 4 doses group 14 days after the first dose of inoculation.
Measured: 3 months
Compare the GMT between two experimental groups
- Compare the GMT between two experimental groups 14 days after the first dose of inoculation.
Measured: 3 months
Geometric Mean Titer (GMT) of 4 doses groups
- Compare the GMT between the SPEEDA 4 doses group and the experimental 4 doses group 14 days after the first dose inoculation.
Measured: 3 months
Safety within 30 minutes
- Incidence rate of any local and systemic adverse events (AE) within 30 minutes after each dose of inoculation;
Measured: 3 months
Safety within 0-7 days
- Incidence rate of collected AE within 0-7 days after each dose of inoculation;
Measured: 3 months
Safety within 6 months
- Incidence rate of all serious adverse events (SAE) within 6 months from the first dose of inoculation to the full course of inoculation.
Measured: 9months
Secondary outcomes (3)
Antibody test of 7 days.
- Antibody test 7 days after the first dose of inoculation.
Measured: 3 months
Antibody test after whole vaccination.
- Antibody test 14days after the whole vaccination.
Measured: 3 months
Persistent observation within 12 months
- Antibody test in different points within 12 months after the whole vaccination.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start22 Jul 2020
- Primary completion31 Oct 2021
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rabies HumanStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,800 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
- NCT05549908
- Sponsor's protocol ID
- ZY201905001
- Status last verified
- Feb 2023
- First submitted
- 14 Sep 2022
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all results.
Publications
Jin F, Zhu L, Wang Y, Qin G, Tian Y, Xie Y, Jin H, Zhang Y, Wang L, Li J, Wu Z, Sheng Y, Shi L, Yang G, Zhao Z, Chen L, Chen P, Jiang Z, Yu J, Gao Z, Li Q, Wu X, Miao L. Randomized, blind, controlled phase III clinical trial: Assessing the immunogenicity and safety of freeze-dried human rabies vaccine (vero cell) with a 4-dose regimen (2-1-1) in a 10-60 year-old demographic. Vaccine. 2024 Oct 3;42(23):126059. doi: 10.1016/j.vaccine.2024.06.026. Epub 2024 Jun 27.
PubMed 38937182
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Blind, Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Freeze-dried Human Rabies Vaccine (Vero Cell) Inoculated in 4-dose Program (2-1-1)
- ClinicalTrials.gov ID
- NCT05549908
- Acronym / sponsor ID
- ZY201905001
- Conditions
- Rabies Human, Antibody Titer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- Changchun Zhuoyi Biological Co., LtdUniversity, hospital or other
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 22 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.
A phase III clinical trial to evaluate the immunogenicity and safety of freeze-dried human rabies vaccine (Vero cell) developed by Changchun Zhuoyi Biological Co., Ltd. inoculated in a 4-dose procedure (2-1-1)
Detailed description
It is to prove that the freeze-dried human rabies vaccine (Vero cell) in the population aged 10-60 years, the four dose vaccination program is not inferior to the five dose vaccination program, and the safty、antibody positive conversion rate and geometric mean concentration of the four dose group of the test vaccine are not inferior to the five dose program group 14 days after the first dose vaccination.
To compare the immunogenicity of people aged 10-60 years old who were vaccinated 6 and 12 months after the whole vaccination, so as to evaluate the antibody positive rate and GMT 6 and 12 months after the test vaccine was vaccinated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental 4 doses | Experimental | Biological: rabies vaccineInoculate experimental vaccine according to 2-1-1 immunization procedure |
| Experimental 5 doses | Experimental | Biological: rabies vaccineInoculate experimental vaccine according to 1-1-1-1-1 immunization procedure |
| SPEEDA® 4 doses | Active comparator | Biological: rabies vaccineInoculate SPEEDA® according to 2-1-1 immunization procedure |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- The age is 10-60 years old;
- Underarm temperature ≤ 37.0 ℃.
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 |
|---|---|---|
| rabies vaccineThe subjects were vaccinated with rabies vaccines with different immunization procedures, and the safety and immunogenicity were compared | Biological | Experimental 4 doses, Experimental 5 doses, SPEEDA® 4 doses |
Primary outcome
Antibody positive conversion rate of experimental groups
Time frame: 3 months
- Compare the Antibody positive conversion rate between two experimental groups 14 days after the first dose of inoculation.
Antibody positive conversion rate of 4 doses groups
Time frame: 3 months
-Compare the Antibody positive conversion rate between the SPEEDA 4 doses group and experimental 4 doses group 14 days after the first dose of inoculation.
Compare the GMT between two experimental groups
Time frame: 3 months
- Compare the GMT between two experimental groups 14 days after the first dose of inoculation.
Geometric Mean Titer (GMT) of 4 doses groups
Time frame: 3 months
- Compare the GMT between the SPEEDA 4 doses group and the experimental 4 doses group 14 days after the first dose inoculation.
Safety within 30 minutes
Time frame: 3 months
- Incidence rate of any local and systemic adverse events (AE) within 30 minutes after each dose of inoculation;
Safety within 0-7 days
Time frame: 3 months
- Incidence rate of collected AE within 0-7 days after each dose of inoculation;
Safety within 6 months
Time frame: 9months
- Incidence rate of all serious adverse events (SAE) within 6 months from the first dose of inoculation to the full course of inoculation.
3 secondary outcomes
Antibody test of 7 days.
Time frame: 3 months
Antibody test after whole vaccination.
Time frame: 3 months
Persistent observation within 12 months
Time frame: 16 months
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 13 Mar 2024.
- Derived from this study: PubMed 38937182Jin F, Zhu L, Wang Y, Qin G, Tian Y, Xie Y, Jin H, Zhang Y, Wang L, Li J, Wu Z, Sheng Y, Shi L, Yang G, Zhao Z, Chen L, Chen P, Jiang Z, Yu J, Gao Z, Li Q, Wu X, Miao L. Randomized, blind, controlled phase III clinical trial: Assessing the immunogenicity and safety of freeze-dried human rabies vaccine (vero cell) with a 4-dose regimen (2-1-1) in a 10-60 year-old demographic. Vaccine. 2024 Oct 3;42(23):126059. doi: 10.1016/j.vaccine.2024.06.026. Epub 2024 Jun 27.
- Individual participant dataSharing planned: Yes. all results.
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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 3 study testing rabies vaccine in people with Rabies Human and Antibody Titer, 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 13 Mar 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Antibody positive conversion rate of experimental groups (time frame: 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05549908, which also lists 1 linked publication.
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 13 Mar 2024.