- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02514746
Long-term Immunogenicity After Receipt of JE Vaccine and Antibody Response and Safety to a Booster Dose
Assessment of Long Term Immunogenicity of Japanese Encephalitis Live Attenuated SA-14-14-2 Vaccine in Previously Vaccinated Bangladeshi Children and Antibody Response and Safety to a Booster Dose
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study participants previously immunized with CD-JEV (Clinical Trials identifier: NCT01567865, JEV05) will have serum collected three and four years after initial vaccination to assess long-term immunogenicity. Four years after receiving the initial dose of CD-JEV, eligible participants will be vaccinated with a second subcutaneous dose of CD-JEV to assess the antibody response.
Participants will be monitored for safety for 28 days following receipt of the booster dose.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participant in JEV05 study (NCT01567865) and received one dose of CD-JEV.
- Resides in the Matlab or Mirpur study area.
- At least one parent or guardian willing to provide written informed consent.
Exclusion Criteria:
- Received a second dose of Japanese encephalitis vaccine within the past three years.
- Received immunoglobulins and/or any blood products within 90 days prior to enrollment.
- Been diagnosed with a primary or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection within the past three years.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Live Attenuated JE SA-14-14-2 Vaccine (CD-JEV)
Participants previously vaccinated with CD-JEV will receive a booster dose of live, attenuated Japanese encephalitis SA-14-14-2 vaccine four years after initial vaccination.
|
0.5 mL subcutaneous injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Seroprotection Rate Three and Four Years After Initial Vaccination With CD-JEV
Time Frame: 3 years after initial vaccination (Study Day 1) and 4 years after initial vaccination (Study Day 365)
|
Seroprotection rate is defined as the percentage of participants with an anti-Japanese encephalitis (JE) neutralizing antibody titer ≥ 1:10 as measured using a 50% plaque reduction neutralization test (PRNT-50).
Seroprotection was assessed at 3 and 4 years after the initial vaccination in Study JEV05, prior to participants receiving a booster vaccination in the current study.
|
3 years after initial vaccination (Study Day 1) and 4 years after initial vaccination (Study Day 365)
|
Geometric Mean Titer of Anti-JE Neutralizing Antibodies Three and Four Years After Initial Vaccination With CD-JEV
Time Frame: 3 years after initial vaccination (Study Day 1) and 4 years after initial vaccination (Study Day 365)
|
The geometric mean titer (GMT) of anti-JE neutralizing antibodies 3 and 4 years after initial vaccination with CD-JEV in Study JEV05 and prior to receiving the booster vaccination in the current study, measured using PRNT-50.
|
3 years after initial vaccination (Study Day 1) and 4 years after initial vaccination (Study Day 365)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Seroprotection Rate 7 Days and 28 Days After Booster Dose
Time Frame: 7 days and 28 days following booster vaccination (Study Days 372 and 393)
|
Seroprotection rate is defined as the percentage of study participants with an anti-JE neutralizing antibody titer ≥1:10 assessed using PRNT-50.
|
7 days and 28 days following booster vaccination (Study Days 372 and 393)
|
GMT of Anti-JE Neutralizing Antibodies 7 Days and 28 Days After Booster Dose
Time Frame: 7 days and 28 days following booster vaccination (Study Days 372 and 393)
|
Geometric mean titer of anti-JE neutralizing antibodies measured using PRNT-50.
|
7 days and 28 days following booster vaccination (Study Days 372 and 393)
|
Seroconversion Rate 7 Days and 28 Days After Booster Dose
Time Frame: 7 days and 28 days following booster vaccination (Study Days 372 and 393)
|
Seroconversion rate is defined as the percentage of study participants with either:
|
7 days and 28 days following booster vaccination (Study Days 372 and 393)
|
GMT Ratio of Anti-JE Neutralizing Antibody Titers Between Post-Booster and Pre-Booster Vaccination
Time Frame: 4 years after the initial vaccination (Study Day 365, pre-booster vaccination) and 7 and 28 days following booster vaccination (Study Days 372 and 393)
|
To evaluate the magnitude of the increase in GMTs, the GMT ratio of anti-JE neutralizing antibody titers between post-booster vaccination and pre-booster vaccination was calculated for the following:
|
4 years after the initial vaccination (Study Day 365, pre-booster vaccination) and 7 and 28 days following booster vaccination (Study Days 372 and 393)
|
Number of Participants With Immediate Reactions 30 Minutes Following Booster Vaccination
Time Frame: 30 minutes following booster vaccination (Study Day 365)
|
The number of participants with at least one occurrence of an immediate reaction, including local, systemic, or unsolicited adverse event that occurred within 30 minutes of the booster vaccination.
|
30 minutes following booster vaccination (Study Day 365)
|
Number of Participants With Solicited Local Reactions Occurring Within 7 Days of Booster Vaccination
Time Frame: From 30 minutes to 7 days following booster vaccination (Study Day 365 to 372)
|
Participants were monitored for local reactions from 30 minutes through 7 days post booster vaccination. Local reactions (at the injection site) included the following:
Local ecchymosis, erythema, edema, and induration were graded as follows:
Injection site pain/tenderness were graded as follows:
|
From 30 minutes to 7 days following booster vaccination (Study Day 365 to 372)
|
Number of Participants With Solicited Systemic Reactions Occurring Within 7 Days of Booster Vaccination
Time Frame: From 30 minutes to 7 days following booster vaccination (Study Day 365 to 372)
|
Participants were monitored for systemic reactions from 30 minutes through 7 days post booster vaccination. Systemic reactions (general signs / symptoms) included the following:
Fever was graded as follows:
Change in eating habits, diarrhea, sleepiness, irritability, unusual crying, vomiting were graded as follows:
|
From 30 minutes to 7 days following booster vaccination (Study Day 365 to 372)
|
Number of Participants With Unsolicited Adverse Events (AEs) and Serious Adverse Events (SAEs) Within 28 Days Following Booster Vaccination
Time Frame: 28 days following booster vaccination (Study Days 365 to 393)
|
AEs were graded for severity according to the following: Grade 1 (Mild): Symptoms causing no or minimal interference with usual social and functional activities Grade 2 (Moderate): Symptoms causing greater than minimal interference with usual social and functional activities Grade 3 (Severe): Symptoms causing inability to perform usual social and functional activities with intervention or hospitalization indicated Grade 4 (Potentially life-threatening): Symptoms causing inability to perform basic self-care functions OR medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. Relationship to study vaccine was based on the Clinician's assessment. A serious adverse event is defined as an AE that meets 1 of the following criteria:
|
28 days following booster vaccination (Study Days 365 to 393)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: K Zaman, PhD, MPH, MBBS, International Centre for Diarrhoeal Disease Research, Bangladesh
Publications and helpful links
General Publications
- Zaman K, Naser AM, Power M, Yaich M, Zhang L, Ginsburg AS, Luby SP, Rahman M, Hills S, Bhardwaj M, Flores J. Lot-to-lot consistency of live attenuated SA 14-14-2 Japanese encephalitis vaccine manufactured in a good manufacturing practice facility and non-inferiority with respect to an earlier product. Vaccine. 2014 Oct 21;32(46):6061-6. doi: 10.1016/j.vaccine.2014.09.012. Epub 2014 Sep 18.
- Zaman K, Yunus M, Aziz AB, Feser J, Mooney J, Tang Y, Ellison DW, Thaisomboonsuk B, Zhang L, Neuzil KM, Marfin AA, Letson GW. Antibody persistence and immune memory response following primary vaccination and boosting with live attenuated SA 14-14-2 Japanese encephalitis vaccine (CD-JEV) in Bangladesh: A phase 4 open-label clinical trial. Vaccine X. 2022 Feb 5;10:100143. doi: 10.1016/j.jvacx.2022.100143. eCollection 2022 Apr.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Encephalitis, Arbovirus
- Encephalitis, Viral
- Central Nervous System Viral Diseases
- Central Nervous System Infections
- Infectious Encephalitis
- Arbovirus Infections
- Vector Borne Diseases
- Flavivirus Infections
- Flaviviridae Infections
- Encephalitis, Japanese
- Encephalitis
Other Study ID Numbers
- JEV07
- PR-15036 (Other Identifier: International Centre for Diarrhoeal Disease Research, Bangladesh)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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