Clinical Trials Logo

Clinical Trial Summary

The proposed Japanese Encephalitis (JE)Vaccine 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 JE live attenuated SA 14-14-2 vaccine manufactured in a new 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 will enroll a total of 1,000 Bangladeshi infants aged 10 to 12 months. In addition to providing immunogenicity data, JEV05 will provide local safety data of JE live attenuated SA 14-14-2 vaccine among Bangladeshi children. This will be 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.


Clinical Trial Description

Vaccination is the most effective intervention to prevent JE and its associated morbidity and mortality (http://www.who.int.nuvi/Je/en). JE live attenuated SA 14-14-2 vaccine has been used in Asia for more than two decades in over 400 million children. Chengdu Institute of Biological Products (CDIBP), a Chinese manufacturer, has been producing JE live attenuated SA 14-14-2 vaccine since 1988. It has been demonstrated to be both safe and immunogenic in several observational and case-control studies providing protection for at least 5 years following a single dose. JE live attenuated SA 14-14-2 vaccine is licensed for use in China, India, Nepal, South Korea, Sri Lanka, and Thailand. Countries that have introduced JE vaccine into their national immunization programs have experienced dramatic reductions in JE incidence, leading WHO to declare vaccination the preferred JE control strategy.4

In order for JE live attenuated SA 14-14-2 vaccine to be available for purchase through UNICEF and GAVI for broader international use, including in Bangladesh, JE live attenuated SA 14-14-2 vaccine needs to undergo WHO prequalification. With technical support from PATH, CDIBP has established a new GMP facility, Building 208 JE production unit, maintaining WHO standards. A GMP Certificate for the new facility was issued on 11/16/2011. This certificate provides market authorization to distribute the new vaccine in China. To achieve WHO prequalification, JE live attenuated SA 14-14-2 vaccine produced in this new GMP facility needs to be shown to be similarly safe and immunogenic to JE live attenuated SA 14-14-2 vaccine produced in the existing facility, the JE viral vaccine production plant, and needs to demonstrate lot-to-lot consistency.

The proposed JEV05 study is a four-arm double-blind randomized controlled single center trial testing the immunogenicity of four lots of JE live attenuated SA 14-14-2 vaccine - three lots manufactured in the new GMP facility and one lot from the existing facility - in a total of 1000 Bangladeshi infants aged 10 to 12 months. The study will be conducted in the Matlab Health and Demographic Surveillance System (HDSS) intervention area, a rural site where many vaccine trials have been conducted.

A 5 ml blood sample will be collected from each child before vaccination and at 28 days post-vaccination. The sera will be tested using a plaque reduction neutralization test (PRNT) with JE neutralizing antibody titers > 1:10 considered seroprotective. The JEV05 trial will provide immunogenicity data on the three vaccine lots produced in the new GMP facility compared to a vaccine lot produced in the prior existing plant. It will also provide local immunogenicity and safety data of JE live attenuated SA 14-14-2 vaccine among Bangladeshi children. This will be 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


NCT number NCT01635816
Study type Interventional
Source International Centre for Diarrhoeal Disease Research, Bangladesh
Contact
Status Completed
Phase Phase 4
Start date May 2012
Completion date December 2012

See also
  Status Clinical Trial Phase
Completed NCT03679234 - Impact of Infant Formula on Caregiver-perceived Intolerance N/A
Completed NCT01681355 - Gastrointestinal Tolerance Study of a New Infant Formula N/A
Active, not recruiting NCT04962594 - Safety and Efficacy of Infant Formulas Supplemented With Pre- and Probiotic(s) N/A
Completed NCT03722550 - Second Generation Human Milk Oligosaccharides Blend Study N/A
Completed NCT03703583 - Infant Feeding Practice and Gut Comfort Study
Not yet recruiting NCT06053112 - The Trial of a New Infant Formula in Healthy Term Chinese Infants N/A
Completed NCT01515644 - Study on the Effect of Inulin in Infant Formula on Gut Health Phase 3
Completed NCT03014115 - Effects of Different ARA Formulations of Infant Formula on Fatty Acid Status, Immune Markers and Infection Rates in Infants N/A
Completed NCT03000543 - Novel Isotope Dilution Technique to Assess Vitamin A Status N/A
Terminated NCT03976596 - Measurement of in Vivo Mitochondrial Capacity in Infants
Recruiting NCT01601197 - A Study of Two Injection Techniques to Reduce Pain in Infants Undergoing Immunization Phase 3
Completed NCT01633216 - Poliovirus Vaccine Trial in Bangladesh Phase 4
Completed NCT00957892 - Effects of Infant Formula Composition on Infant Feeding Behaviors N/A
Completed NCT03801161 - Influence of Inflammation on Micronutrient Status Assessment N/A
Recruiting NCT06073652 - Starter Infant Formula With Synbiotics N/A
Completed NCT01825109 - Improving Rotavirus Vaccine Immune Response Phase 3
Withdrawn NCT01507935 - Colonisation Resistance Study Phase 2
Completed NCT01594840 - Changing Chat: Diaper Tips to Improve Language Development N/A
Not yet recruiting NCT01249911 - Lactobacillus Reuteri DSM 17938 and Prevention of Respiratory and Gastrointestinal Infections in Mexican Infants Phase 3
Completed NCT03007108 - Age-dependency of Thrombin Generation Using a New Standardized Assay N/A