Rabies ExposureNCT07120464
Clinical Study on Immunogenicity and Safety of Lyophilized Vero Cell-Derived Human Rabies Vaccine in Special Populations
An observational study of Rabies Exposure and Immunocompromised, run by Liaoning Chengda Biotechnology CO., LTD at 1 site in China.
Trial summary
This study adopts a parallel-controlled design and includes a study group and a control group. The study group will enroll 150 special population participants (including non-HIV-related immunocompromised individuals, patients with chronic diseases, and elderly individuals) who receive their first post-exposure… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Rabies Exposure, Immunocompromised, Chronic Disease
- What is being tested?
- Observation Only
- Type of treatment
- Vaccines
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This study uses a parallel controlled design with two groups: a study group and a control group. The study group will enroll approximately 150 special population subjects who present for post-exposure prophylaxis after category II or III rabies exposure. These special populations include individuals with immunocompromised conditions excluding HIV infection, patients with chronic diseases, and elderly subjects. The control group will include approximately 30 healthy adults aged 18 to less than 60 years presenting for post-exposure prophylaxis after category II or III rabies exposure.
Who may be able to join
- Subjects with WHO category II or III rabies exposure presenting at the study site for post-exposure prophylaxis and vaccination.
- Subjects planned to be included in the control group, aged 18 to less than 60 years old, healthy as confirmed by medical history, physical examination, and clinical judgment before vaccination.
- Subjects planned to be included in the study group who meet any of the following conditions:
- Long-term immunocompromised status due to conditions including, but not limited to: clinically confirmed primary immunodeficiency diseases; hematologic or solid organ malignancies; aplastic anemia; clinically confirmed autoimmune diseases with immunosuppressive therapy lasting 4 weeks or longer within the past 12 months prior to enrollment; history of splenectomy or other major immunologic organ removal; hematopoietic stem cell or solid organ transplantation within 2 years prior to enrollment.
- Clinically confirmed diabetes mellitus, chronic hepatitis, liver cirrhosis, chronic glomerulonephritis, nephrotic syndrome, or chronic renal insufficiency.
- Age 60 years or older.
- Subjects or their legally authorized representatives are able to understand the study requirements and procedures, voluntarily agree to participate, and sign the informed consent form.
- Subjects are able to comply with all planned follow-up visits and provide valid identification documents of themselves and/or their legally authorized representatives.
Who cannot join
- History of previous rabies vaccination.
- History of human immunodeficiency virus (HIV) infection.
- Other conditions deemed unsuitable for participation in the clinical study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Luohu District People's Hospital.
Shenzhen, Guangdong
Lanxiang Wang, 349111794@qq.com
About this study
This study adopts a parallel-controlled design and includes a study group and a control group. The study group will enroll 150 special population participants (including non-HIV-related immunocompromised individuals, patients with chronic diseases, and elderly individuals) who receive their first post-exposure treatment following WHO category II or III rabies exposure. The control group will include 30 healthy adults with similar exposure.
Blood samples will be collected at Day 14 and Day 90 after completion of the full vaccination schedule to assess rabies virus neutralizing antibody seroconversion rates and titers. Immunogenicity and antibody persistence will be compared between the two groups. Additionally, all adverse events occurring within 30 minutes and within 7 days after each dose will be recorded to evaluate safety.
Read the detailed description
This is a controlled study consisting of a study group and a control group. The study group will include special population participants (non-HIV-related immunocompromised individuals, patients with chronic diseases, and elderly individuals) who are receiving their first clinical visit after confirmed WHO category II or III rabies exposure. The control group will include healthy adults aged 18 to under 60 years who also present after similar exposure. The study group will be further divided into three subgroups based on the health status of the participants, with 50 individuals in each subgroup:
- Immunocompromised group: including individuals with primary immunodeficiency diseases, hematologic or solid organ malignancies, aplastic anemia, and autoimmune diseases under long-term immunosuppressive therapy;
- Chronic disease group: including patients with diabetes, chronic hepatitis, cirrhosis, chronic glomerulonephritis, nephrotic syndrome, and chronic renal insufficiency;
- Elderly group: participants aged 60 years and above (including those aged exactly 60).
If a participant meets criteria for more than one subgroup (e.g., aged ≥60 years and also has immunodeficiency or a chronic disease), subgroup assignment will be prioritized based on disease condition: immunocompromised first, then chronic disease, and finally elderly, to ensure each participant is assigned to the most representative subgroup.
All participants (both in the study and control groups) may choose either the Zagreb regimen (2-1-1) or the Essen regimen (five-dose schedule) for post-exposure rabies vaccination. Adverse events occurring within 0-7 days after each vaccine dose will be collected via telephone follow-up to understand post-vaccination responses.
Blood samples will be collected at Day 14 after completion of the full vaccination schedule (i.e., Day 35 from first dose for Zagreb regimen and Day 42 for Essen regimen), and again at Day 90 (Day 111 and Day 118 from first dose for Zagreb and Essen, respectively). Rabies virus neutralizing antibodies will be tested and compared between groups to evaluate the immunogenicity of rabies vaccination in special populations after exposure. Safety data will also be analyzed and compared between groups.
- Conditions
- Rabies Exposure, Immunocompromised, Chronic Disease
- Being tested
- Observation Only
- Keywords
- Immunocompromised Patients, Chronic Diseases, Elderly Population, Rabies Vaccine, Vaccine Immunogenicity
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation OnlyOther
All participants will receive post-exposure rabies vaccination using either the Zagreb or Essen regimen, in accordance with national immunization guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adult Control Group | Healthy adults aged 18 to under 60 years who seek medical attention after confirmed WHO category II or III rabies exposure and have no known chronic illness or immunocompromising condition. Receives: Other: Observation Only | |
| Immunocompromised Group | Participants diagnosed with rabies category II or III exposure who are immunocompromised due to conditions such as primary immunodeficiency, hematologic or solid malignancies, aplastic anemia, or autoimmune diseases receiving long-term immunosuppressive therapy. A total of 50 participants will be enrolled in this group. Receives: Other: Observation Only | |
| Chronic Disease Group | Participants diagnosed with rabies category II or III exposure who have chronic health conditions including diabetes, chronic hepatitis, cirrhosis, chronic glomerulonephritis, nephrotic syndrome, or chronic renal insufficiency. A total of 50 participants will be enrolled in this group. Receives: Other: Observation Only | |
| Elderly Group | Participants aged 60 years and above (including those aged exactly 60) with category II or III rabies exposure and no exclusionary comorbidities beyond age-related health changes. A total of 50 participants will be enrolled in this group. Receives: Other: Observation Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rabies virus neutralizing antibody (RVNA) seropositivity rate and antibody level at Day 14 after full vaccination
The proportion of subjects with rabies virus neutralizing antibody (RVNA) ≥ 0.5 IU/ml and the antibody titer level in serum at 14 days after completion of the full vaccination schedule.
Measured: 14 days post completion of full vaccination.
Rabies virus neutralizing antibody (RVNA) seropositivity rate and antibody level at Day 90 after full vaccination
he proportion of subjects with RVNA ≥ 0.5 IU/ml and the antibody titer level in serum at 90 days after completion of the full vaccination schedule.
Measured: 90 days post completion of full vaccination.
Secondary outcomes (1)
Safety profile of rabies vaccine
Incidence of local (injection site) and systemic (non-injection site) adverse events/reactions within 30 minutes and up to 7 days after each vaccine dose, including serious adverse events and other adverse events.
Measured: Within 30 minutes and 7 days after each vaccine dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rabies ExposureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaoning Chengda Biotechnology CO., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shenzhen Center for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Fang Huang, Principal investigator, Shenzhen Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120464
- Sponsor's protocol ID
- CDB-RV-PM-2025001
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 13 Aug 2025
- 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 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Immunogenicity and Safety of Lyophilized Vero Cell-Derived Human Rabies Vaccine in Special Populations
- ClinicalTrials.gov ID
- NCT07120464
- Acronym / sponsor ID
- CDB-RV-PM-2025001
- Conditions
- Rabies Exposure, Immunocompromised, Chronic Disease
- Keywords
- Immunocompromised Patients, Chronic Diseases, Elderly Population, Rabies Vaccine, Vaccine Immunogenicity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Liaoning Chengda Biotechnology CO., LTDIndustry (pharma, biotech, devices)
- Collaborators
- Shenzhen Center for Disease Control and Prevention
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Aug 2025 (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.
This study adopts a parallel-controlled design and includes a study group and a control group. The study group will enroll 150 special population participants (including non-HIV-related immunocompromised individuals, patients with chronic diseases, and elderly individuals) who receive their first post-exposure treatment following WHO category II or III rabies exposure. The control group will include 30 healthy adults with similar exposure.
Blood samples will be collected at Day 14 and Day 90 after completion of the full vaccination schedule to assess rabies virus neutralizing antibody seroconversion rates and titers. Immunogenicity and antibody persistence will be compared between the two groups. Additionally, all adverse events occurring within 30 minutes and within 7 days after each dose will be recorded to evaluate safety.
Detailed description
This is a controlled study consisting of a study group and a control group. The study group will include special population participants (non-HIV-related immunocompromised individuals, patients with chronic diseases, and elderly individuals) who are receiving their first clinical visit after confirmed WHO category II or III rabies exposure. The control group will include healthy adults aged 18 to under 60 years who also present after similar exposure. The study group will be further divided into three subgroups based on the health status of the participants, with 50 individuals in each subgroup:
- Immunocompromised group: including individuals with primary immunodeficiency diseases, hematologic or solid organ malignancies, aplastic anemia, and autoimmune diseases under long-term immunosuppressive therapy;
- Chronic disease group: including patients with diabetes, chronic hepatitis, cirrhosis, chronic glomerulonephritis, nephrotic syndrome, and chronic renal insufficiency;
- Elderly group: participants aged 60 years and above (including those aged exactly 60).
If a participant meets criteria for more than one subgroup (e.g., aged ≥60 years and also has immunodeficiency or a chronic disease), subgroup assignment will be prioritized based on disease condition: immunocompromised first, then chronic disease, and finally elderly, to ensure each participant is assigned to the most representative subgroup.
All participants (both in the study and control groups) may choose either the Zagreb regimen (2-1-1) or the Essen regimen (five-dose schedule) for post-exposure rabies vaccination. Adverse events occurring within 0-7 days after each vaccine dose will be collected via telephone follow-up to understand post-vaccination responses.
Blood samples will be collected at Day 14 after completion of the full vaccination schedule (i.e., Day 35 from first dose for Zagreb regimen and Day 42 for Essen regimen), and again at Day 90 (Day 111 and Day 118 from first dose for Zagreb and Essen, respectively). Rabies virus neutralizing antibodies will be tested and compared between groups to evaluate the immunogenicity of rabies vaccination in special populations after exposure. Safety data will also be analyzed and compared between groups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Adult Control Group | – | Other: Observation OnlyHealthy adults aged 18 to under 60 years who seek medical attention after confirmed WHO category II or III rabies exposure and have no known chronic illness or immunocompromising condition. |
| Immunocompromised Group | – | Other: Observation OnlyParticipants diagnosed with rabies category II or III exposure who are immunocompromised due to conditions such as primary immunodeficiency, hematologic or solid malignancies, aplastic anemia, or autoimmune diseases receiving long-term immunosuppressive therapy. A total of 50 participants will be enrolled in this group. |
| Chronic Disease Group | – | Other: Observation OnlyParticipants diagnosed with rabies category II or III exposure who have chronic health conditions including diabetes, chronic hepatitis, cirrhosis, chronic glomerulonephritis, nephrotic syndrome, or chronic renal insufficiency. A total of 50 participants will be enrolled in this group. |
| Elderly Group | – | Other: Observation OnlyParticipants aged 60 years and above (including those aged exactly 60) with category II or III rabies exposure and no exclusionary comorbidities beyond age-related health changes. A total of 50 participants will be enrolled in this group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study uses a parallel controlled design with two groups: a study group and a control group. The study group will enroll approximately 150 special population subjects who present for post-exposure prophylaxis after category II or III rabies exposure. These special populations include individuals with immunocompromised conditions excluding HIV infection, patients with chronic diseases, and elderly subjects. The control group will include approximately 30 healthy adults aged 18 to less than 60 years presenting for post-exposure prophylaxis after category II or III rabies exposure.
Key inclusion criteria (8 listed)
- Subjects with WHO category II or III rabies exposure presenting at the study site for post-exposure prophylaxis and vaccination.
- Subjects planned to be included in the control group, aged 18 to less than 60 years old, healthy as confirmed by medical history, physical examination, and clinical judgment before vaccination.
- Subjects planned to be included in the study group who meet any of the following conditions:
- Subjects or their legally authorized representatives are able to understand the study requirements and procedures, voluntarily agree to participate, and sign the informed consent form.
- Subjects are able to comply with all planned follow-up visits and provide valid identification documents of themselves and/or their legally authorized representatives.
Key exclusion criteria (3 listed)
- History of previous rabies vaccination.
- History of human immunodeficiency virus (HIV) infection.
- Other conditions deemed unsuitable for participation in the clinical study by the investigator.
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 |
|---|---|---|
| Observation OnlyAll participants will receive post-exposure rabies vaccination using either the Zagreb or Essen regimen, in accordance with national immunization guidelines. | Other | Chronic Disease Group, Elderly Group, Healthy Adult Control Group, Immunocompromised Group |
Primary outcome
Rabies virus neutralizing antibody (RVNA) seropositivity rate and antibody level at Day 14 after full vaccination
Time frame: 14 days post completion of full vaccination.
The proportion of subjects with rabies virus neutralizing antibody (RVNA) ≥ 0.5 IU/ml and the antibody titer level in serum at 14 days after completion of the full vaccination schedule.
Rabies virus neutralizing antibody (RVNA) seropositivity rate and antibody level at Day 90 after full vaccination
Time frame: 90 days post completion of full vaccination.
he proportion of subjects with RVNA ≥ 0.5 IU/ml and the antibody titer level in serum at 90 days after completion of the full vaccination schedule.
1 secondary outcome
Safety profile of rabies vaccine
Time frame: Within 30 minutes and 7 days after each vaccine dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Fang Huang principal investigator
Shenzhen Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rabies Exposure and Immunocompromised, run by Liaoning Chengda Biotechnology 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 8 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: looking for participants now, as of the sponsor's last update on 13 Aug 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Tong (15811315908, 14877107@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rabies virus neutralizing antibody (RVNA) seropositivity rate and antibody level at Day 14 after full vaccination (time frame: 14 days post completion of full vaccination.). The study lists 2 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 13 Aug 2025.