Japanese EncephalitisPhase 4NCT06678373
Monitoring JE Antibody Levels in Healthy Populations and Immunization Strategy in Low-Prevalence Areas
A Phase 4 study testing Liaoning Chengda Inactivated Japanese Encephalitis Vaccine in people with Japanese Encephalitis, run by Liaoning Chengda Biotechnology CO., LTD at 1 site in China.
Trial summary
This study aims to assess the neutralizing antibody levels and prevalence risk of Japanese encephalitis among residents in low-endemic areas, as well as to evaluate the immunogenicity, safety, and immune persistence of the inactivated Japanese encephalitis vaccine across different age groups in healthy populations. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Japanese Encephalitis
- What is being tested?
- Liaoning Chengda Inactivated Japanese Encephalitis Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2024to 31 Dec 2026
- Phase
- Phase 4
- 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Permanent residents aged 6 years (inclusive) and older;
- Healthy individuals as determined clinically after inquiring about medical history and conducting relevant physical examinations;
- Individuals who meet the vaccination criteria for the inactivated Japanese encephalitis vaccine (Vero cells);
- Participants must provide informed consent to receive vaccination and blood c collection; minors must obtain informed consent from their guardians;
- Participants planned to be included in Group A must have previously completed the full vaccination schedule for the Japanese encephalitis vaccine (including live attenuated vaccine or inactivated vaccine).
Who cannot join
- Participants are unwilling to sign the informed consent form;
- History of allergy to the vaccine or its components, severe adverse reactions to the vaccine such as allergies, urticaria, breathing difficulties, angioedema, or abdominal pain;
- Individuals with encephalopathy, uncontrolled epilepsy, and other progressive neurological diseases;
- History of seizures or convulsions, or family history of psychiatric disorders;
- Presence of congenital malformations or developmental disorders, genetic defects, and severe malnutrition;
- Individuals with autoimmune diseases, congenital or acquired immunodeficiencies, or family history of autoimmune diseases or immunodeficiencies;
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- Any acute diseases or acute exacerbations of chronic diseases in the past 7 days;
- Treatment with immunosuppressants, anti-allergy treatments, cytotoxic therapies, or inhaled corticosteroids (excluding corticosteroid spray treatments for allergic rhinitis or topical corticosteroid treatments for acute non-complicated dermatitis) in the past 6 months;
- Administration of immunoglobulin injections within 1 month prior to vaccination;
- Individuals with fever before vaccination, with axillary temperature >37.0°C;
- History of Japanese encephalitis;
- Other factors deemed inappropriate for participation in the clinical observational study as determined by the researcher;
- Participants planned for inclusion in Groups B and C must have received the Japanese encephalitis vaccine (including live attenuated vaccine and inactivated vaccine) in the past;
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
China1 site
Liaoning Provincial Center for Disease Control and Prevention
Shenyang, Liaoning, 110100
About this study
This study aims to assess the neutralizing antibody levels and prevalence risk of Japanese encephalitis among residents in low-endemic areas, as well as to evaluate the immunogenicity, safety, and immune persistence of the inactivated Japanese encephalitis vaccine across different age groups in healthy populations. The study uses an open-label, single-arm trial design with a sample size of 250 participants. Primary endpoints include pre- and post-vaccination serum neutralizing antibody levels, seroconversion rates, and incidence of adverse events.
Read the detailed description
This study aims to gain an in-depth understanding of neutralizing antibody levels against Japanese encephalitis among residents in low-endemic areas to assess potential outbreak risks and to evaluate the immunogenicity, safety, and immune persistence of the inactivated Japanese encephalitis vaccine across different age groups in a healthy population. This open-label, single-arm trial is structured in two phases: Phase I will involve stratified sampling of residents aged 6 years and older for serological testing, followed by administration of the inactivated JE vaccine to assess safety, with serological testing conducted 28 days post-vaccination. Phase II will conduct serological testing 365 days post-primary immunization to evaluate immune persistence.
The target population includes residents aged 6 and older, divided into Group A (ages 6-17), Group B (ages 18-39), and Group C (ages 18+), with different vaccine dosages for each group. Inclusion criteria encompass age, health status, and informed consent, while exclusion criteria cover allergies, serious illness, and recent vaccination. Primary endpoints will include pre- and post-vaccination serum neutralizing antibody levels, seroconversion rates, average antibody levels, and post-vaccination adverse event incidence. The project is scheduled to begin in October 2024 and conclude in December 2026, with the primary research unit being the Liaoning Provincial Center for Disease Control and Prevention, aiming to provide a scientific basis for JE control and prevention in this region.
- Conditions
- Japanese Encephalitis
- Being tested
- Liaoning Chengda Inactivated Japanese Encephalitis Vaccine
- Medical subject headings
- Encephalitis, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liaoning Chengda Inactivated Japanese Encephalitis VaccineBiological
The patient needs to receive 1 dose of inactivated Japanese encephalitis vaccine.
Liaoning Chengda Inactivated Japanese Encephalitis VaccineBiological
The patient needs to receive 2 doses of inactivated Japanese encephalitis vaccine, with an interval of 28 days.
Liaoning Chengda Inactivated Japanese Encephalitis VaccineBiological
The patient needs to receive 2 doses of inactivated Japanese encephalitis vaccine, with an interval of 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Group A(Ages 6 to 17) | Experimental | The patient needs to receive 1 dose of inactivated Japanese encephalitis vaccine. Receives: Biological: Liaoning Chengda Inactivated Japanese Encephalitis Vaccine |
| Group B(Ages 18 to 39) | Experimental | The patient needs to receive 2 doses of inactivated Japanese encephalitis vaccine, with an interval of 28 days. Receives: Biological: Liaoning Chengda Inactivated Japanese Encephalitis Vaccine |
| Group C(C1 Age 18-39 years) | Experimental | The patient needs to receive 2 doses of inactivated Japanese encephalitis vaccine, with an interval of 7 days. Receives: Biological: Liaoning Chengda Inactivated Japanese Encephalitis Vaccine |
| Group C(C2 Age 40-59 years) | Experimental | The patient needs to receive 2 doses of inactivated Japanese encephalitis vaccine, with an interval of 7 days. Receives: Biological: Liaoning Chengda Inactivated Japanese Encephalitis Vaccine |
| Group C(C3 Age 60 years and above) | Experimental | The patient needs to receive 2 doses of inactivated Japanese encephalitis vaccine, with an interval of 7 days. Receives: Biological: Liaoning Chengda Inactivated Japanese Encephalitis Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of JE neutralizing antibody levels in low-prevalence areas to evaluate the risk of JE transmission.
Before administering the first dose of the vaccine, at least 3 ml of the recipient's venous blood will be collected. Transport the serum under frozen conditions to the testing laboratory for analysis. The serum Japanese encephalitis neutralizing antibodies will be detected using the Plaque Reduction Neutralization Test (PRNT50). A neutralizing antibody titer of < 1:10 before vaccination is considered negative, while a titer of ≥ 1:10 after vaccination is considered positive. If the pre-vaccination antibody titer is ≥ 1:10, an increase of fourfold or more in the post-vaccination antibody titer is also considered a positive result.
Measured: Prior to administration of the first vaccine dose.
Seroconversion rate and average neutralizing antibody levels against JE on the 28th day after vaccination.
After completing all doses of the trial, collect at least 3 ml of venous blood from the subjects on day 28. Transport the serum under frozen conditions to the testing laboratory for analysis. The serum Japanese encephalitis neutralizing antibodies will be detected using the Plaque Reduction Neutralization Test (PRNT50). A neutralizing antibody titer of < 1:10 before vaccination is considered negative, while a titer of ≥ 1:10 after vaccination is considered positive. If the pre-vaccination antibody titer is ≥ 1:10, an increase of fourfold or more in the post-vaccination antibody titer is also considered a positive result.
Measured: On the 28th day after vaccination.
Secondary outcomes (2)
Seroconversion rate and average neutralizing antibody levels against JE on the 365th day after vaccination.
After completing all doses of the trial, collect at least 3 ml of venous blood from the subjects on day 365. Transport the serum under frozen conditions to the testing laboratory for analysis. The serum Japanese encephalitis neutralizing antibodies will be detected using the Plaque Reduction Neutralization Test (PRNT50). A neutralizing antibody titer of < 1:10 before vaccination is considered negative, while a titer of ≥ 1:10 after vaccination is considered positive. If the pre-vaccination antibody titer is ≥ 1:10, an increase of fourfold or more in the post-vaccination antibody titer is also considered a positive result.
Measured: On the 365th day after vaccination.
Adverse event rate
- The incidence, severity, and correlation of any adverse events (AEs) at the injection site (local) and non-injection site (systemic) within 30 minutes after each dose;
- The incidence, severity, and correlation of AEs within 0-7 days after each dose;
- The incidence and correlation of all AEs and serious adverse events (SAEs) occurring within 30 days after the complete vaccination.
Measured: Within 30 days after vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start14 Nov 2024
- Primary completion30 Apr 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 Japanese EncephalitisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaoning Chengda Biotechnology CO., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xing Fang, Principal investigator, Liaoning Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678373
- Sponsor's protocol ID
- CDB-JE-PM-2023004
- Status last verified
- Dec 2024
- First submitted
- 6 Nov 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- 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 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring JE Antibody Levels in Healthy Populations and Immunization Strategy in Low-Prevalence Areas
- ClinicalTrials.gov ID
- NCT06678373
- Acronym / sponsor ID
- CDB-JE-PM-2023004
- Conditions
- Japanese Encephalitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Liaoning Chengda Biotechnology CO., LTDIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Nov 2024 (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 aims to assess the neutralizing antibody levels and prevalence risk of Japanese encephalitis among residents in low-endemic areas, as well as to evaluate the immunogenicity, safety, and immune persistence of the inactivated Japanese encephalitis vaccine across different age groups in healthy populations. The study uses an open-label, single-arm trial design with a sample size of 250 participants. Primary endpoints include pre- and post-vaccination serum neutralizing antibody levels, seroconversion rates, and incidence of adverse events.
Detailed description
This study aims to gain an in-depth understanding of neutralizing antibody levels against Japanese encephalitis among residents in low-endemic areas to assess potential outbreak risks and to evaluate the immunogenicity, safety, and immune persistence of the inactivated Japanese encephalitis vaccine across different age groups in a healthy population. This open-label, single-arm trial is structured in two phases: Phase I will involve stratified sampling of residents aged 6 years and older for serological testing, followed by administration of the inactivated JE vaccine to assess safety, with serological testing conducted 28 days post-vaccination. Phase II will conduct serological testing 365 days post-primary immunization to evaluate immune persistence.
The target population includes residents aged 6 and older, divided into Group A (ages 6-17), Group B (ages 18-39), and Group C (ages 18+), with different vaccine dosages for each group. Inclusion criteria encompass age, health status, and informed consent, while exclusion criteria cover allergies, serious illness, and recent vaccination. Primary endpoints will include pre- and post-vaccination serum neutralizing antibody levels, seroconversion rates, average antibody levels, and post-vaccination adverse event incidence. The project is scheduled to begin in October 2024 and conclude in December 2026, with the primary research unit being the Liaoning Provincial Center for Disease Control and Prevention, aiming to provide a scientific basis for JE control and prevention in this region.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A(Ages 6 to 17) | Experimental | Biological: Liaoning Chengda Inactivated Japanese Encephalitis VaccineThe patient needs to receive 1 dose of inactivated Japanese encephalitis vaccine. |
| Group B(Ages 18 to 39) | Experimental | Biological: Liaoning Chengda Inactivated Japanese Encephalitis VaccineThe patient needs to receive 2 doses of inactivated Japanese encephalitis vaccine, with an interval of 28 days. |
| Group C(C1 Age 18-39 years) | Experimental | Biological: Liaoning Chengda Inactivated Japanese Encephalitis VaccineThe patient needs to receive 2 doses of inactivated Japanese encephalitis vaccine, with an interval of 7 days. |
| Group C(C2 Age 40-59 years) | Experimental | Biological: Liaoning Chengda Inactivated Japanese Encephalitis VaccineThe patient needs to receive 2 doses of inactivated Japanese encephalitis vaccine, with an interval of 7 days. |
| Group C(C3 Age 60 years and above) | Experimental | Biological: Liaoning Chengda Inactivated Japanese Encephalitis VaccineThe patient needs to receive 2 doses of inactivated Japanese encephalitis vaccine, with an interval of 7 days. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Permanent residents aged 6 years (inclusive) and older;
- Healthy individuals as determined clinically after inquiring about medical history and conducting relevant physical examinations;
- Individuals who meet the vaccination criteria for the inactivated Japanese encephalitis vaccine (Vero cells);
- Participants must provide informed consent to receive vaccination and blood c collection; minors must obtain informed consent from their guardians;
- Participants planned to be included in Group A must have previously completed the full vaccination schedule for the Japanese encephalitis vaccine (including live attenuated vaccine or inactivated vaccine).
Key exclusion criteria (14 listed)
- Participants are unwilling to sign the informed consent form;
- History of allergy to the vaccine or its components, severe adverse reactions to the vaccine such as allergies, urticaria, breathing difficulties, angioedema, or abdominal pain;
- Individuals with encephalopathy, uncontrolled epilepsy, and other progressive neurological diseases;
- History of seizures or convulsions, or family history of psychiatric disorders;
- Presence of congenital malformations or developmental disorders, genetic defects, and severe malnutrition;
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 |
|---|---|---|
| Liaoning Chengda Inactivated Japanese Encephalitis VaccineThe patient needs to receive 1 dose of inactivated Japanese encephalitis vaccine. | Biological | Group A(Ages 6 to 17) |
| Liaoning Chengda Inactivated Japanese Encephalitis VaccineThe patient needs to receive 2 doses of inactivated Japanese encephalitis vaccine, with an interval of 28 days. | Biological | Group B(Ages 18 to 39) |
| Liaoning Chengda Inactivated Japanese Encephalitis VaccineThe patient needs to receive 2 doses of inactivated Japanese encephalitis vaccine, with an interval of 7 days. | Biological | Group C(C1 Age 18-39 years), Group C(C2 Age 40-59 years), Group C(C3 Age 60 years and above) |
Primary outcome
Assessment of JE neutralizing antibody levels in low-prevalence areas to evaluate the risk of JE transmission.
Time frame: Prior to administration of the first vaccine dose.
Before administering the first dose of the vaccine, at least 3 ml of the recipient's venous blood will be collected. Transport the serum under frozen conditions to the testing laboratory for analysis. The serum Japanese encephalitis neutralizing antibodies will be detected using the Plaque Reduction Neutralization Test (PRNT50). A neutralizing antibody titer of < 1:10 before vaccination is considered negative, while a titer of ≥ 1:10 after vaccination is considered positive. If the pre-vaccination antibody titer is ≥ 1:10, an increase of fourfold or more in the post-vaccination antibody titer is also considered a positive result.
Seroconversion rate and average neutralizing antibody levels against JE on the 28th day after vaccination.
Time frame: On the 28th day after vaccination.
After completing all doses of the trial, collect at least 3 ml of venous blood from the subjects on day 28. Transport the serum under frozen conditions to the testing laboratory for analysis. The serum Japanese encephalitis neutralizing antibodies will be detected using the Plaque Reduction Neutralization Test (PRNT50). A neutralizing antibody titer of < 1:10 before vaccination is considered negative, while a titer of ≥ 1:10 after vaccination is considered positive. If the pre-vaccination antibody titer is ≥ 1:10, an increase of fourfold or more in the post-vaccination antibody titer is also considered a positive result.
2 secondary outcomes
Seroconversion rate and average neutralizing antibody levels against JE on the 365th day after vaccination.
Time frame: On the 365th day after vaccination.
Adverse event rate
Time frame: Within 30 days after vaccination.
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 Dec 2024.
- 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. This study is not recruiting at the moment.
Xing Fang principal investigator
Liaoning Provincial 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?
A Phase 4 study testing Liaoning Chengda Inactivated Japanese Encephalitis Vaccine in people with Japanese Encephalitis, 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 5 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 13 Dec 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 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?
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?
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?
Assessment of JE neutralizing antibody levels in low-prevalence areas to evaluate the risk of JE transmission. (time frame: Prior to administration of the first vaccine dose.). 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 Dec 2024.