Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A(Ages 6 to 17) | Experimental | The patient needs to receive 1 dose of 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liaoning Chengda Inactivated Japanese Encephalitis Vaccine | Biological | The patient needs to receive 1 dose of inactivated Japanese encephalitis vaccine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | On the 28th day after vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xing Fang | Liaoning Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liaoning Provincial Center for Disease Control and Prevention | Shenyang | Liaoning | 110100 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Liaoning Chengda Inactivated Japanese Encephalitis Vaccine | Biological | The patient needs to receive 2 doses of inactivated Japanese encephalitis vaccine, with an interval of 28 days. |
|
| Liaoning Chengda Inactivated Japanese Encephalitis Vaccine | Biological | The patient needs to receive 2 doses of inactivated Japanese encephalitis vaccine, with an interval of 7 days. |
|
| On the 365th day after vaccination. |
| Adverse event rate |
| Within 30 days after vaccination. |
| ID | Term |
|---|---|
| D004672 | Encephalitis, Japanese |
| ID | Term |
|---|---|
| D004671 | Encephalitis, Arbovirus |
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D000069544 | Infectious Encephalitis |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D000096724 | Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D012327 | RNA Virus Infections |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D004660 | Encephalitis |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
Not provided
Not provided