VaccinePhase 3NCT07672626
Safety and Immune Response of a Rabies Vaccine With the Essen Schedule and a Two-Dose Booster
A Phase 3 study testing the tested vaccine in people with Vaccine, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial summary
Rabies is caused by rabies virus with a 100% mortality rate in humans. Most of cases occur in Africa and Asia, mainly in underserved populations. Rabies is a vaccine-preventable disease in both humans and animals. Read more about this study
- Who is it for?
- Ages 10 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine
- What is being tested?
- the tested vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 19 Jul 2022to 16 Dec 2024
- 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
- Healthy subjects aged 10-60 years as established by medical history and clinical examination
- The subjects are able to understand and sign the informed consent
- Female subjects aged 18-60 years must have a negative urine pregnancy test result and commit to using contraception for 2 months following the first vaccine dose in this study.
- Subjects who can and will comply with the requirements of the protocol
- Subjects with temperature ≤37.0°C on axillary setting
Who cannot join
- Subject who was administered human rabies vaccine or rabies immunoglobulin.
- Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, especially allergic to neomycin.
- Has been diagnosed or suspected of having an immune deficiency, autoimmune disease, or immune system disorder.
- History of thyroidectomy, or thyroid disease requiring treatmentin the past 12 months
- Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with injections or blood draws
- History of epilepsy, convulsions or convulsions, or a family history of psychosis.
Show all 26Show fewer
- Absence of spleen, functional absence of spleen, and any circumstances leading to absence of spleen or splenectomy.
- Have a malignant tumor in active phase, or a tumor that have been treated but not clearly cured, or may relapse during the study period.
- In the past 6 months, there have been immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and surface corticosteroid therapy for acute non-complicated dermatitis).
- Taking anti-TB or HIV treatment.
- Any prior administration of immunoglobulin or blood products in last 3 months.
- Coagulopathy (such as coagulation factor deficiency, coagulative disorders, platelet abnormalities) or obvious bruising or coagulation impairment
- Any prior administration of other research drugs in last 30 days
- Any prior administration of attenuated live vaccine in last 4 weeks
- Any prior administration of subunit or inactivated vaccines in last 2 weeks
- Have acute diseases, severe chronic diseases, acute exacerbation of chronic diseases, or those with fever
- Suspected or have a history of injury caused by warm-blooded mammals in last 3 months.
- Women who are breastfeeding, pregnant, or planning to become pregnant in 2 months past the first dose.
- Use of antipyretic, analgesic, or antiallergic drugs within 3 days
- Having used other investigational or unregistered products (drugs or vaccines) within 6 months prior to the vaccination of the study vaccine, or having plans to participate in other clinical studies after enrollment in this clinical study (except for emergency-use novel coronavirus vaccines, but the vaccination details must be recorded in the concomitant medication section)
- Planning to move out of the local area or be away from the local area for a long time before the end of the study;
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
- Any incidences in the first dose exclusion criteria occur after inclusion
- Grade 3 or higher systemic adverse reactions related to this study, or intolerable injection site adverse reactions, that occurred between the previous vaccination and the current vaccination.
- Any serious adverse events caused by vaccination.
- Other reactions that in the opinion of the investigator ( include: severely serious symptom of pain, swelling, Limitation of motion, continuous high fever, headache and other Systemic or local reactions )
Trial locations and contacts
1 site in 1 country.
China1 site
Pizhou county Center for Disease Control and Prevention
Pizhou, Jiangsu
About this study
Official title: Immunogenicity and Safety of Freeze-Dried Human Rabies Vaccine (Vero Cell) With the "Essen" Immunization Schedule and a Two-Dose Booster in Chinese Healthy Subjects Aged 10-60 Years: A Randomized, Blinded, and Comparable Vaccine-Controlled Non-Inferiority Phase III Clinical Trial.
Rabies is caused by rabies virus with a 100% mortality rate in humans. Most of cases occur in Africa and Asia, mainly in underserved populations. Rabies is a vaccine-preventable disease in both humans and animals. Over the years, the Vero cell rabies vaccine has been recognized by the World Health Organization (WHO) and the European Union, and is widely used globally. Currently, one of the post-exposure prophylaxis (PEP) regimens recommended by the World Health Organization (WHO) is the five-dose "Essen" regimen (1-1-1-1-1), involving one intramuscular dose administered on days 0, 3, 7, 14, and 28 respectively. This clinical trial was to assess the immunogenicity and safety of a freeze-dried human rabies vaccine (Vero Cell) in healthy population for the large-scale developing, and explore the booster vaccination.
Read the detailed description
Rabies is caused by rabies virus with a case fatality rate approaching 100% in humans. Studies reported that about 59000 human deaths and over 3.7 million disability-adjusted life years lost every year. Most of cases occur in Africa and Asia, mainly in underserved populations, with approximately 40% of cases in children aged <15 years. Fortunately, rabies is a vaccine-preventable disease in both humans and animals. Post-exposure prophylaxis (PEP), is the critical intervention for preventing the onset of the disease.
Conventional Vero cell rabies vaccines have been used globally for decades, demonstrating excellent safety and immunogenicity. However, their production typically requires the use of animal-derived components, such as fetal bovine serum or human serum albumin, in the cell culture medium. This practice raises potential concerns regarding the risk of contamination with adventitious agents, batch-to-batch variability, and the potential for allergic reactions. To address these limitations, a new generation of purified Vero rabies vaccine produced in serum-free medium has been developed. This vaccine uses the same Pitman-Moore virus strain as the traditional vaccines but is manufactured without any human or animal serum-derived components, significantly reducing the risk of extraneous protein contamination and representing a substantial advancement in vaccine technology and safety. The shift to a serum-free production process, while a clear advantage for safety, raises critical questions regarding the vaccine's immunogenicity and the duration of protection it confers.
This study aims to systematically evaluate the available evidence of the serum-free Vero cell rabies vaccine. First, we will critically assess its immunogenicity in PEP settings. Second, we will assess the long-term persistence of protective antibody titers following primary vaccination. Finally, we will discuss the rationale for and evidence on booster vaccination strategies.
- Conditions
- Vaccine
- Being tested
- the tested vaccine, the control vaccine
- Keywords
- human rabies vaccine (Vero Cell), immunogenicity, safety, Essen regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the tested vaccineBiological
The tested vaccine is a lyophilized human rabies vaccine (Vero Cells) produced by Shanghai Rongsheng Biotech Co., Ltd.
the control vaccineBiological
The control vaccine is a lyophilized human rabies vaccine (Vero Cells) produced by Liaoning Chengda Biotechnology Co., Ltd.
| Study group | Role | What they receive |
|---|---|---|
| the tested group | Experimental | receive the lyophilized human rabies vaccine (Vero Cells) produced by Shanghai Rongsheng Biotech Co., Ltd. Receives: Biological: the tested vaccine |
| the control group | Active comparator | receive the lyophilized human rabies vaccine (Vero Cells) produced by Liaoning Chengda Biotechnology Co., Ltd. Receives: Biological: the control vaccine |
| Sub tested A | Experimental | Subjects from the tested group with freeze-dried human rabies vaccine (Vero Cell) (Shanghai Rongsheng Biotech Co., Ltd.) vaccinated according to booster schedule on day 0,3 at month 3 following the full-course immunization. Receives: Biological: the tested vaccine |
| Sub tested B | Experimental | Subjects from the experimental 1 with freeze-dried human rabies vaccine (Vero Cell) (Shanghai Rongsheng Biotech Co., Ltd.) vaccinated according to booster schedule on day 0,3 at month 12 following the full-course immunization. Receives: Biological: the tested vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate of rabies virus-specific neutralizing antibodies (RFFIT) in pre-immunization seronegative subjects.
Percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml, the experimental group is non-inferior to the control group, non-inferiority margin for seroconversion rate:-5%.
Measured: 14 days following the 5 doses full-course immunization
Geometric mean concentration (GMC) of rabies virus-specific neutralizing antibodies in pre-immunization seronegative subjects.
GMC, concentration of participants with rabies virus neutralizing antibody concentration, the experimental group is non-inferior to the control group, non-inferiority margin for GMC ratio:0.67.
Measured: 14 days following the 5 doses full-course immunization
Seroconversion rate of rabies virus-specific neutralizing antibodies (RFFIT) in pre-immunization seronegative subjects.
Seroconversion rate, percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml, the experimental group is non-inferior to the control group, non-inferiority margin for seroconversion rate:-5%.
Measured: 14 days following the first dose
Geometric mean concentration (GMC) of rabies virus-specific neutralizing antibodies in pre-immunization seronegative subjects.
GMC, concentration of participants with rabies virus neutralizing antibody concentration, the experimental group is non-inferior to the control group, non-inferiority margin for GMC ratio:0.67.
Measured: 14 days following the first dose
Secondary outcomes (6)
Percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml or increase by 4 folds after vaccination
Measured: 7、14 days post the first dose and 14 days post the 5 doses full-course immunization
Geometric mean concentration (GMC) of rabies virus-specific neutralizing antibodies
Measured: 7、14 days post the first dose and 14 days post the 5 doses full-course immunization
Percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml after vaccination.
Measured: Month 3、6、12 following the 5 doses full-course immunization
GMC of rabies virus neutralizing antibody
Measured: Month 3、6、12 following the 5 doses full-course immunization
Proportion of subjects reporting adverse events
Measured: Day 30 post-each dose
Proportion of subjects with Serious Adverse Events occurring throughout the trial
Measured: Day 0 up to month 12 following the full-course immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start19 Jul 2022
- Primary completion26 Aug 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaccineStudies 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
- Model description
- Model Description
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Fengcai Zhu, Jiangsu Province Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672626
- Sponsor's protocol ID
- JSVCT146
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Freeze-Dried Human Rabies Vaccine (Vero Cell) With the "Essen" Immunization Schedule and a Two-Dose Booster in Chinese Healthy Subjects Aged 10-60 Years: A Randomized, Blinded, and Comparable Vaccine-Controlled Non-Inferiority Phase III Clinical Trial.
- ClinicalTrials.gov ID
- NCT07672626
- Acronym / sponsor ID
- JSVCT146
- Conditions
- Vaccine
- Keywords
- human rabies vaccine (Vero Cell), immunogenicity, safety, Essen regimen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 29 Jun 2026 (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.
Rabies is caused by rabies virus with a 100% mortality rate in humans. Most of cases occur in Africa and Asia, mainly in underserved populations. Rabies is a vaccine-preventable disease in both humans and animals. Over the years, the Vero cell rabies vaccine has been recognized by the World Health Organization (WHO) and the European Union, and is widely used globally. Currently, one of the post-exposure prophylaxis (PEP) regimens recommended by the World Health Organization (WHO) is the five-dose "Essen" regimen (1-1-1-1-1), involving one intramuscular dose administered on days 0, 3, 7, 14, and 28 respectively. This clinical trial was to assess the immunogenicity and safety of a freeze-dried human rabies vaccine (Vero Cell) in healthy population for the large-scale developing, and explore the booster vaccination.
Detailed description
Rabies is caused by rabies virus with a case fatality rate approaching 100% in humans. Studies reported that about 59000 human deaths and over 3.7 million disability-adjusted life years lost every year. Most of cases occur in Africa and Asia, mainly in underserved populations, with approximately 40% of cases in children aged <15 years. Fortunately, rabies is a vaccine-preventable disease in both humans and animals. Post-exposure prophylaxis (PEP), is the critical intervention for preventing the onset of the disease.
Conventional Vero cell rabies vaccines have been used globally for decades, demonstrating excellent safety and immunogenicity. However, their production typically requires the use of animal-derived components, such as fetal bovine serum or human serum albumin, in the cell culture medium. This practice raises potential concerns regarding the risk of contamination with adventitious agents, batch-to-batch variability, and the potential for allergic reactions. To address these limitations, a new generation of purified Vero rabies vaccine produced in serum-free medium has been developed. This vaccine uses the same Pitman-Moore virus strain as the traditional vaccines but is manufactured without any human or animal serum-derived components, significantly reducing the risk of extraneous protein contamination and representing a substantial advancement in vaccine technology and safety. The shift to a serum-free production process, while a clear advantage for safety, raises critical questions regarding the vaccine's immunogenicity and the duration of protection it confers.
This study aims to systematically evaluate the available evidence of the serum-free Vero cell rabies vaccine. First, we will critically assess its immunogenicity in PEP settings. Second, we will assess the long-term persistence of protective antibody titers following primary vaccination. Finally, we will discuss the rationale for and evidence on booster vaccination strategies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| the tested group | Experimental | Biological: the tested vaccinereceive the lyophilized human rabies vaccine (Vero Cells) produced by Shanghai Rongsheng Biotech Co., Ltd. |
| the control group | Active comparator | Biological: the control vaccinereceive the lyophilized human rabies vaccine (Vero Cells) produced by Liaoning Chengda Biotechnology Co., Ltd. |
| Sub tested A | Experimental | Biological: the tested vaccineSubjects from the tested group with freeze-dried human rabies vaccine (Vero Cell) (Shanghai Rongsheng Biotech Co., Ltd.) vaccinated according to booster schedule on day 0,3 at month 3 following the full-course immunization. |
| Sub tested B | Experimental | Biological: the tested vaccineSubjects from the experimental 1 with freeze-dried human rabies vaccine (Vero Cell) (Shanghai Rongsheng Biotech Co., Ltd.) vaccinated according to booster schedule on day 0,3 at month 12 following the full-course immunization. |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Healthy subjects aged 10-60 years as established by medical history and clinical examination
- The subjects are able to understand and sign the informed consent
- Female subjects aged 18-60 years must have a negative urine pregnancy test result and commit to using contraception for 2 months following the first vaccine dose in this study.
- Subjects who can and will comply with the requirements of the protocol
- Subjects with temperature ≤37.0°C on axillary setting
Key exclusion criteria (26 listed)
- Subject who was administered human rabies vaccine or rabies immunoglobulin.
- Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, especially allergic to neomycin.
- Has been diagnosed or suspected of having an immune deficiency, autoimmune disease, or immune system disorder.
- History of thyroidectomy, or thyroid disease requiring treatmentin the past 12 months
- Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with injections or blood draws
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 |
|---|---|---|
| the tested vaccineThe tested vaccine is a lyophilized human rabies vaccine (Vero Cells) produced by Shanghai Rongsheng Biotech Co., Ltd. | Biological | Sub tested A, Sub tested B, the tested group |
| the control vaccineThe control vaccine is a lyophilized human rabies vaccine (Vero Cells) produced by Liaoning Chengda Biotechnology Co., Ltd. | Biological | the control group |
Primary outcome
Seroconversion rate of rabies virus-specific neutralizing antibodies (RFFIT) in pre-immunization seronegative subjects.
Time frame: 14 days following the 5 doses full-course immunization
Percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml, the experimental group is non-inferior to the control group, non-inferiority margin for seroconversion rate:-5%.
Geometric mean concentration (GMC) of rabies virus-specific neutralizing antibodies in pre-immunization seronegative subjects.
Time frame: 14 days following the 5 doses full-course immunization
GMC, concentration of participants with rabies virus neutralizing antibody concentration, the experimental group is non-inferior to the control group, non-inferiority margin for GMC ratio:0.67.
Seroconversion rate of rabies virus-specific neutralizing antibodies (RFFIT) in pre-immunization seronegative subjects.
Time frame: 14 days following the first dose
Seroconversion rate, percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml, the experimental group is non-inferior to the control group, non-inferiority margin for seroconversion rate:-5%.
Geometric mean concentration (GMC) of rabies virus-specific neutralizing antibodies in pre-immunization seronegative subjects.
Time frame: 14 days following the first dose
GMC, concentration of participants with rabies virus neutralizing antibody concentration, the experimental group is non-inferior to the control group, non-inferiority margin for GMC ratio:0.67.
6 secondary outcomes
Percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml or increase by 4 folds after vaccination
Time frame: 7、14 days post the first dose and 14 days post the 5 doses full-course immunization
Geometric mean concentration (GMC) of rabies virus-specific neutralizing antibodies
Time frame: 7、14 days post the first dose and 14 days post the 5 doses full-course immunization
Percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml after vaccination.
Time frame: Month 3、6、12 following the 5 doses full-course immunization
GMC of rabies virus neutralizing antibody
Time frame: Month 3、6、12 following the 5 doses full-course immunization
Proportion of subjects reporting adverse events
Time frame: Day 30 post-each dose
Proportion of subjects with Serious Adverse Events occurring throughout the trial
Time frame: Day 0 up to month 12 following the full-course immunization
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 29 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 the tested vaccine in people with Vaccine, run by Jiangsu Province Centers for Disease Control and Prevention 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 5 inclusion and 26 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 29 Jun 2026. 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?
Seroconversion rate of rabies virus-specific neutralizing antibodies (RFFIT) in pre-immunization seronegative subjects. (time frame: 14 days following the 5 doses full-course immunization). 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 29 Jun 2026.