A Clinical Trial in Healthy Infants to Assess Lot-to-lot Consistency of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine and Non-inferiority With Respect to an Earlier Product.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Japanese Encephalitis
- Sponsor
- PATH
- Enrollment
- 818
- Locations
- 1
- Primary Endpoint
- Number/Percentage of Subjects With Demonstrated Seroprotection
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The proposed study is a four-arm double-blind randomized controlled single center trial to evaluate, by examining post-vaccination seroprotection titers, the lot-to-lot consistency of three lots of Japanese Encephalitis live attenuated SA 14-14-2 vaccine (LJEVac) manufactured in a new good manufacture practice (GMP) facility, and to establish non-inferiority of the new vaccine in comparison to a single lot of the same vaccine manufactured in the existing facility. The study aimed to enroll a total of 1,000 Bangladeshi infants aged 10 to 12 months. In addition to providing immunogenicity data, this study provided local safety data of JE live attenuated SA 14-14-2 vaccine among Bangladeshi children. This is the first step to secure licensure for this life-saving vaccine in Bangladesh as well as provide data to support WHO prequalification of JE live attenuated SA 14-14-2 vaccine.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Infant's parent(s) or legal guardian(s) willing to provide signed informed consent.
- •Healthy infants aged 10 to 12 months at enrolment residing in Matlab Health and Demographic Surveillance System (HDSS) intervention area who have completed all doses of Expanded Programme on Immunization (EPI) immunizations at least 4 weeks prior to enrolment: Bacillus Calmette-Guerin vaccine (BCG), Diphtheria-pertussis-tetanus vaccine (DPT), Hepatitis B (HBV), Haemophilus influenzae type (Hib), oral polio vaccine (OPV) and measles
Exclusion Criteria
- •Acute medical illness with or without fever within the last 72 hours or an axillary temperature (≥ 37.5°C ) at the time of vaccination.
- •Use of antibiotics or antipyretics within the last 72 hours prior to enrolment.
- •Severely or moderately malnourished infants (\<-3 Z score).
- •History of prematurity (\< 36 weeks of pregnancy).
- •Underlying medical condition such as failure to thrive, inborn errors of metabolism, bronchopulmonary dysplasia, or any major congenital abnormalities requiring surgery or chronic treatment.
- •History of serious chronic disease (e.g., cardiac, renal, neurologic, metabolic, rheumatologic, hematologic, or bleeding disorder).
- •Known or suspected impairment of immunologic function.
- •History of documented or suspected encephalitis or meningitis.
- •History of seizures, including history of febrile seizures, or any other neurologic disorder.
- •History of JE infection.
Outcomes
Primary Outcomes
Number/Percentage of Subjects With Demonstrated Seroprotection
Time Frame: 28 days post-vaccination
Seroprotection was defined as a serum antibody titer equal to or greater than 1:10, as measured by Plaque reduction neutralization test (PRNT). The end point for neutralization was the highest dilution of serum reducing the number of plaques by 50%, compared with a negative serum control. In 2004, a group of experts under the leadership of the WHO recommended that seroprotection (SP) against JEV be defined as a neutralizing anti-JEV antibody serum titer ≥1:10 as determined by PRNT \[Hombach et al. 2005\]. Accordingly, a titer of ≥1:10 was adopted as an indicator of seroprotection in this study.
Geometric Mean Titers (GMT)
Time Frame: 28 days post-vaccination
Geometric Mean Titers of Neutralizing anti-JEV antibody
Secondary Outcomes
- Number/Percentage of Subjects With an Immediate Solicited Local or Systemic Reactogenicity Event (RE)(Within 30 minutes of vaccination)
- Number/Percentage of Subjects With a Solicited Local or Systemic Reactogenicity Event Within 7 Days After Vaccination(Within 7 days of vaccination)
- Number/Percentage of Subjects With Other Adverse Events (AE) During the Study(Between 7 and 28 days of vaccination)