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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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).

Detailed Summary:

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.

Sponsor: PATH

Current Primary Outcome:

• 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
• 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

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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
• 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
• 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
• 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

Original Secondary Outcome: Same as current

Information By: PATH

Dates:
Date Received: July 15, 2015
Date Started: July 2015
Date Completion:
Last Updated: April 5, 2017
Last Verified: March 2016