In this issue:
Vol. 8, November 2007
It has been a busy year for the JE project and our
partners around the world. Since our last issue of JE Newsbriefs, we have seen advancements in many areas related to
JE control. Surveillance in several countries continues to shed light on the
regional burden of JE disease, and clinical trials are generating critical
evidence that will further boost the safety profile of JE vaccines. As you
will read below,
We hope you enjoy the update below and, as always, please contact us with any comments or questions. I am confident that our partners join me in looking forward to a fruitful and productive new year!
Dr. Kathleen M. Neuzil
year’s final campaigns pending in
Results from long term follow-up of a JE Project study on the coadministration of measles and live JE vaccines reveal continued protection. One year post-vaccination, measles seroprotection rates were still high after receipt of measles vaccine administered with or without live JE vaccine among infants who originally seroconverted for measles by one month. These results, combined with those from the original study, increase confidence that live JE vaccine may be provided along with measles vaccine in routine EPI programs without the need of an additional JE vaccination visit. Moreover, coadministration of live JE and measles vaccines has the potential to increase coverage rates for immunization against measles, which are quite low in many JE endemic regions.
Construction for a new vaccine manufacturing facility at the Chengdu Institute of Biological Products (CDIBP) broke ground on July 10, with representatives from CDIBP, the China National Biotec Group (CNBG), Technip, and PATH in attendance. Under an agreement that PATH negotiated with CDIBP, the new facility and increased production capacity will allow for an affordable, sustainable supply of JE vaccine, with special pricing for public-sector use in the region. Construction is following WHO standards for good manufacturing practices, and the facility is scheduled to be on line by the end of 2008.
PATH and the Sri Lankan Ministry of Health recently launched a clinical trial to evaluate the safety and immunogenicity of SA 14-14-2 JE vaccine among 2- and 5-year old children who previously received doses of the inactivated vaccine. These data will help the Sri Lankan government determine whether to transition from the inactivated vaccine currently used in the national program to the live, attenuated vaccine, which could result in cost savings to benefit other areas of the immunization program and health system.
An additional part of the study will determine the
safety and immunogenicity of measles and SA 14-14-2 JE vaccines given
together. If data show that co-administration does not negatively impact the
effectiveness of the measles vaccine, this will support the feasibility of
introducing SA 14-14-2 into the routine immunization program, as it will not
require an additional clinic visit. PATH previously studied the co-administration
of these two vaccines in the
In June 2007, PATH launched a
study to analyze cost-effectiveness of JE vaccines in
Intercell and Biological E launched a pediatric Phase II clinical trial in India last July to study Intercell’s JE vaccine among children between one and three years old. The study will compare the vaccine’s safety and immunogenicity with that of the locally-available, mouse brain-derived vaccine. Results are expected later this year, and a Phase 3 trial among children and adults will follow. Click here to learn more.
Representatives from CDIBP and
The Research Institute
of Tropical Medicine (RITM) is the principal facility for infectious
disease research of the Philippines Department of Health and served as an
integral partner in PATH’s clinical trials to determine the safety and
immunogenicity of co-administering vaccines against measles and JE. The team
from RITM was instrumental in obtaining regulatory approvals for the study
and was responsible for all aspects of implementation at the study site,
including participant recruitment and enrollment, administration of vaccines
and blood draws, and shipment of study samples to the trial’s central
contributions to the coadministration study are directly in line with the
institute’s mission to research the control, prevention, and treatment
of tropical diseases that impact the
Tang Yi’s experiences
Dr. Tang is a primary liaison to CDIBP, with whom he is collaborating closely to prepare the file for submission of the SA 14-14-2 JE vaccine for WHO prequalification. Along with a background in scientific research and product development, Tang draws from existing relationships with government institutions and agencies to manage this and other project related to manufacturing and regulatory affairs. In this light, he sees his most important role as a bridge between the organization and the Chinese government.
JE on PATH’s Vaccine Resource Library
JE films: Kill or cure? Japanese encephalitis and Shadow lives: The human toll of Japanese encephalitis
Masthead photo: Richard Lord