In this issue:   

Vol. 8, November 2007

 

Greetings colleagues,

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, India is making unprecedented strides in its campaigns to protect vulnerable children, and JE vaccines in development hold promise for a strong, sustainable, and affordable supply.

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!

Sincerely,

Dr. Kathleen M. Neuzil

Interim Director
jeproject@path.org

 

Nearly 30 million Indian children vaccinated against JE

With this year’s final campaigns pending in India’s districts of Bihar and Kerala, children and adolescents reached through the government’s JE vaccine introduction program is nearing 30 million. Outreach in 2007 has provided vaccine to almost 20 million, and last year’s inaugural campaigns protected more 9.3 million more. India has been a leader in the region in terms of commitment to JE control, spearheaded by the Ministry of Health & Family Welfare with technical assistance provided by PATH. Click here to view a slide show of images from JE vaccination campaigns in India.

 

Follow-up study shows longterm protection when measles and JE vaccines are given together

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.

 

Groundbreaking ceremony held for new facility at Chengdu Institute

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.

Studies initiated to advance JE control
in Sri Lanka

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 Philippines, and both proved to be as immunogenic when given together as when either is given alone.

 

Cost-effectiveness study to inform JE control strategy in Cambodia

In June 2007, PATH launched a study to analyze cost-effectiveness of JE vaccines in Cambodia, collaborating with the Communicable Disease Control Department and the National Immunization Program of the National Institute of Public Health. Five hospital sentinel sites are collecting data using the meningoencephalitis syndromic surveillance system. Results are expected in mid-2008 and will help guide decision-making, inform immunization policy, and provide recommendations on JE vaccine introduction.

Clinical trial in India will test Intercell’s JE vaccine

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.

PATH hosts CDIBP delegates for steering committee meeting

Representatives from CDIBP and CNBG visited Seattle for a steering committee meeting on September 18. Committee members discussed progress toward WHO prequalification of the SA 14-14-2 JE vaccine, the status of clinical trials on coadministration of JE and measles vaccines, public-sector pricing, and future markets in several Asian countries. The delegation also visited the Bill & Melinda Gates Foundation and met with PATH president Chris Elias (pictured center).

Partner profile: Research Institute of Tropical Medicine

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 laboratory at Mahidol University in Thailand. The partnership has extended for a follow-up study to evaluate the long-term immunogenicity of children vaccinated in the original coadministration trial, and RITM was also chosen as the site for PATH’s JE/dengue interaction study planned for 2008.

RITM’s 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 Philippines. In addition to clinical studies, RITM develops cost-effective strategies, conducts training, produces biological products and vaccines, and provides treatment to patients suffering from tropical diseases that fall within the facility’s scope of expertise.

 

Who's who at the PATH JE project: Tang Yi

Tang Yi’s experiences working in China’s pharmaceutical industry have given him insight and connections crucial to advancing the JE project’s relationship with vaccine manufacturers. Dr. Tang joined PATH in March 2007, and his position with the JE project and the Vaccine Development Strategic Program marks his first time working directly with vaccines. As a program officer in the PATH China office, this latest step in his career allows Dr. Tang to blend old experiences with new perspectives.

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 resources


JE project web page   
www.path.org/je

JE on PATH’s Vaccine Resource Library
www.path.org/vaccineresources/japanese_encephalitis.php  

Japanese encephalitis online training module (AIM series)
http://aim.path.org/en/vaccines/je/index.html

 

JE films: Kill or cure? Japanese encephalitis and Shadow lives: The human toll of Japanese encephalitis

www.path.org/vaccineresources/japanese_encephalitis-films.php

WHO Position Paper on JE

www.path.org/vaccineresources/files/WHO_JE_position_paper_2006.pdf

 

Masthead photo: Richard Lord