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Long-term Immunogenicity After Receipt of JE Vaccine and Antibody Response and Safety to a Booster Dose

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ClinicalTrials.gov Identifier: NCT02514746
Recruitment Status : Completed
First Posted : August 4, 2015
Last Update Posted : November 26, 2018
Sponsor:
Collaborator:
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by (Responsible Party):
PATH

Brief Summary:
This study aims to understand the persistence of the Japanese encephalitis (JE) antibody response in previously vaccinated children. The proposed study is a phase 4 open-label trial enrolling up to 818 Bangladeshi children who had previously participated in a lot to lot consistency study (JEV05) of JE live attenuated SA 14-14-2 vaccine (CD-JEV).

Condition or disease Intervention/treatment Phase
Encephalitis, Japanese Biological: SA-14-14-2 live, attenuated JE vaccine Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 561 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : July 30, 2015
Actual Primary Completion Date : December 15, 2016
Actual Study Completion Date : January 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis

Arm Intervention/treatment
Experimental: SA-14-14-2 live, attenuated JE vaccine (CD-JEV)
Participants previously vaccinated with CD-JEV, will receive a booster dose of CD-JEV four years after initial vaccination
Biological: SA-14-14-2 live, attenuated JE vaccine
0.5 ml (single dose), Subcutaneous
Other Names:
  • CD.JEVAX
  • CD-JEV




Primary Outcome Measures :
  1. Long-term antibody response three years after CD-JEV vaccination among children who received a single dose of vaccine between 10-12 months of age [ Time Frame: 3 years following vaccination in JEV05 ]
    Proportion of study participants with an anti-JE neutralizing antibody titer ≥1:10

  2. Long-term antibody response four years after CD-JEV vaccination among children who received a single dose of vaccine between 10-12 months of age [ Time Frame: 4 years following vaccination in JEV05 ]
    Proportion of study participants with an anti-JE neutralizing antibody titer ≥1:10


Secondary Outcome Measures :
  1. Frequency counts and percentage of participants with immediate reactions 30 minutes following booster dose [ Time Frame: 30 minutes following booster vaccination ]
    Frequency counts and percentage of participants reporting immediate unsolicited adverse events (AEs) occurring within 30 minutes of booster vaccination as a measure of safety

  2. Frequency counts and percentage of participants reporting solicited AEs occurring within 7 days of booster vaccination [ Time Frame: 7 days following booster vaccination ]
    Frequency counts and percentage of participants reporting solicited local and systemic AEs occurring within 7 days of booster vaccination as a measure of safety

  3. Frequency counts and percentage of participants reporting unsolicited AEs and serious adverse events (SAEs) within 28 days following booster dose [ Time Frame: 28 days following booster vaccination ]
    Frequency counts and percentage of participants reporting unsolicited AEs and SAEs occurring within 28 days of booster vaccination as a measure of safety

  4. Antibody response following a booster dose of CD-JEV given at five years of age, among children who previously received a single dose of CD-JEV between 10 and 12 months of age. [ Time Frame: 28 days following booster vaccination ]
    Proportion of study participants with an anti-JE neutralizing antibody titer ≥1:10


Other Outcome Measures:
  1. Persistence of antibody response [ Time Frame: 28 days following booster vaccination ]
    Proportion of participants with demonstrated seropositivity for anti-JE immunoglobulin M (IgM) prior to the booster dose and 7 days post booster dose as measured by enzyme-linked immuno assay (ELISA).



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Ages Eligible for Study:   43 Months to 51 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant in JEV05 study 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 HIV infection within the past three years.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514746


Sponsors and Collaborators
PATH
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
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Principal Investigator: K Zaman, PhD, MPH, MBBS International Centre for Diarrhoeal Disease Research, Bangladesh

Publications of Results:
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Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT02514746     History of Changes
Other Study ID Numbers: JEV07 - PR-15036
First Posted: August 4, 2015    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Keywords provided by PATH:
Japanese Encephalitis Vaccines
Flavivirus Infections
Additional relevant MeSH terms:
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Encephalitis, Japanese
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections
Vaccines
Antibodies
Immunologic Factors
Physiological Effects of Drugs