Immunogenicity, Safety, and Antibody Persistence of Different Immunization Strategies Against Japanese Encephalitis

NCT06825312 | Active Not Recruiting Phase 4

• 1 other identifier: CDB-JE-PM-2023002
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 6

Brief Summary

The main objective of this study is to evaluate the persistence of Japanese encephalitis antibodies in participants at the age of 6, after they have followed different Japanese encephalitis vaccination schedules. Furthermore, the study will assess the immunogenicity and antibody persistence of primary immunization across different Japanese encephalitis vaccination schedules, as well as the immunogenicity following booster immunizations within these schedules. The safety of each vaccine dose will also be evaluated.

Conditions

Japanese Encephalitis Vaccine

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Testing Seropositive for Japanese Encephalitis Neutralizing Antibodies

  The persistence of immunity following various Japanese encephalitis (JE) vaccination schedules is evaluated based on the proportion of participants exhibiting seropositivity for JE neutralizing antibodies at 6 years of age. Seropositivity is defined as a JE neutralizing antibody titer of at least 1:10, as ascertained by the 50% plaque reduction neutralization test.

  4 years after the booster vaccination at 24 months of age

Secondary Outcomes (7)

• Seroconversion Rates of Japanese Encephalitis Neutralizing Antibodies after Primary vaccination

  30 days post-primary immunization

• Geometric Mean Titer of Japanese Encephalitis Neutralizing Antibodies before and after Primary Immunization

  pre-primary immunization (Day 0) and 30 days post-primary immunization

• Percentage of Participants Testing Seropositive for Japanese Encephalitis Neutralizing Antibodies before and after Primary Immunization

  pre-primary immunization (Day 0) and 30 days post-primary immunization

• Seroconversion Rates of Japanese Encephalitis Neutralizing Antibodies after Booster vaccination

  30 days post-booster immunization

• Geometric Mean Titer of Japanese Encephalitis Neutralizing Antibodies before and after booster Immunization

  pre-booster immunization (Day 0) and 30 days post-booster immunization

Study Arms (6)

Group 1 (4 doses of JEV-I)

EXPERIMENTAL

Participants will receive 2 doses of JEV-I (7-10 days apart) at 8 months of age, 1 dose of JEV-I at 24 months of age, and 1 dose of JEV-I at 6 years of age.

Biological: Japanese Encephalitis Vaccine (Vero Cell), Inactivated

Group 2 (4 doses of JEV-I)

EXPERIMENTAL

Participants will receive 2 doses of JEV-I (28-35 days apart) at 8 months of age, 1 dose of JEV-I at 24 months of age, and 1 dose of JEV-I at 6 years of age.

Biological: Japanese Encephalitis Vaccine (Vero Cell), Inactivated

Group 3 (2 doses of JEV-I and 1 dose of JEV-L)

EXPERIMENTAL

Participants will receive 2 doses of JEV-I (7-10 days apart) at 8 months of age and 1 dose of JEV-L at 24 months of age.

Biological: Japanese Encephalitis Vaccine (Vero Cell), Inactivated; Biological: Japanese Encephalitis Vaccine, Live

Group 4 (1 dose of JEV-L and 2 doses of JEV-I)

EXPERIMENTAL

Participants will receive 1 dose of JEV-L at 8 months of age and 2 doses of JEV-I (7-10 days apart) at 24 months of age.

Biological: Japanese Encephalitis Vaccine (Vero Cell), Inactivated; Biological: Japanese Encephalitis Vaccine, Live

Group 5 (1 dose of JEV-L and 2 doses of JEV-I)

EXPERIMENTAL

Participants will receive 1 dose of JEV-L at 8 months of age, 1 dose of JEV-I at 24 months of age, and 1 dose of JEV-I at 6 years of age.

Biological: Japanese Encephalitis Vaccine (Vero Cell), Inactivated; Biological: Japanese Encephalitis Vaccine, Live

Group 6 (2 doses of JEV-L)

ACTIVE COMPARATOR

Participants will receive 2 doses of JEV-L at 8 months of age, and 1 dose of JEV-L at 24 months of age.

Biological: Japanese Encephalitis Vaccine, Live

Interventions

Japanese Encephalitis Vaccine (Vero Cell), Inactivated BIOLOGICAL

0.5ml for each dose, manufactured by Liaoning Chengda Biotechnology Co., Ltd., administered in the deltoid area of lateral arm by intramuscular injection.

Group 1 (4 doses of JEV-I); Group 2 (4 doses of JEV-I); Group 3 (2 doses of JEV-I and 1 dose of JEV-L); Group 4 (1 dose of JEV-L and 2 doses of JEV-I); Group 5 (1 dose of JEV-L and 2 doses of JEV-I)

Japanese Encephalitis Vaccine, Live BIOLOGICAL

0.5ml for each dose, manufactured by Chengdu Institute of Biological Products Co., Ltd., administered subcutaneously in the lower part of the deltoid area of lateral arm.

Group 3 (2 doses of JEV-I and 1 dose of JEV-L); Group 4 (1 dose of JEV-L and 2 doses of JEV-I); Group 5 (1 dose of JEV-L and 2 doses of JEV-I); Group 6 (2 doses of JEV-L)

Eligibility Criteria

• Age: 8 Months - 8 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children aged 8 months who are permanent residents of the study area.
• Legal guardians can understand the requirements and processes of the study, provide written informed consent, and comply with all procedures as required by the clinical research protocol.
• Able to receive the full course of Japanese encephalitis vaccinations according to the immunization strategy in the research protocol, including receiving the primary immunization at 8 months of age and the booster immunizations at 24 months of age and 6 years of age.

You may not qualify if:

• Unable to finish the full course of primary and booster immunizations at the study area, and unable to fulfill the follow-up visits prescribed in the protocol.
• Non-compliance with the vaccination strategy for each group, as stated in the protocol, regarding Japanese encephalitis vaccines with proper doses and varieties.
• Allergic to any component of the study vaccine or having a history of allergic reactions to any vaccines.
• Having a history of symptoms or signs of neurological diseases or other contraindications for Japanese encephalitis vaccine vaccination.
• Having used immunosuppressants or blood products following birth.
• Receiving other vaccines simultaneously while receiving the Japanese encephalitis vaccine of this project.
• Any conditions that may interfere with the evaluation of the study, as deemed by the researcher.

Sponsors & Collaborators

• Liaoning Chengda Biotechnology CO., LTD: lead
• Zhejiang Provincial Center for Disease Control and Prevention: collaborator

Study Sites (6)

Jiashan County Center for Disease Control and Prevention

Jiaxing, Zhejiang, China

Location

Pinghu Center For Disease Control and Prevention

Jiaxing, Zhejiang, China

Location

Dongyang Center for Disease Control and Prevention

Jinhua, Zhejiang, China

Location

Yongkang Center for Disease Control and Prevention

Jinhua, Zhejiang, China

Location

Yuyao Center for Disease Control and Prevention

Ningbo, Zhejiang, China

Location

Jiangshan Center For Disease Control and Prevention

Quzhou, Zhejiang, China

Location

MeSH Terms

Interventions

Japanese Encephalitis Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Huanyu Wang

  Liaoning Chengda Biotechnology CO., LTD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: February 13, 2025
• Study Start: November 11, 2023
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: March 11, 2025

Record last verified: 2025-02

Locations

CN (6)