Rotavirus Update May 2007

Dear partners and colleagues, We are pleased to present the latest issue of Rotavirus Update, including news on groundbreaking clinical trials and updated estimates of global disease burden. These accomplishments are the fruit of strong partnerships, and we are fortunate to have the opportunity to work together with many of the world’s leading organizations and institutions involved in advancing rotavirus vaccines. From April 25 to 27, the field’s partners gathered in Lisbon, Portugal, to attend the Fourth International Conference on Vaccines for Enteric Diseases. While those in attendance may work in very different fields, from industry and laboratory science to finance and health systems, each of us shares the same goal of reducing child mortality and morbidity from diarrheal disease. Rotavirus vaccines have the potential to achieve a monumental impact toward this goal, and together we are moving ever closer to realizing that potential. It is a privilege for us to work with so many dedicated professionals, and we look forward to continuing our collaborations to ensure that rotavirus vaccines reach all who need them. John R. Wecker, PhD Director, PATH Rotavirus Vaccine Program				May 2007 In this Issue Promising trial results add to evidence on rotavirus vaccination in Asia WHO releases updated estimates of global rotavirus disease burden Update on clinical trials in Africa and Asia European network established with surveillance initiated in four countries Learn more about advisory committee review of RotaTeq® vaccine safety in US Rotavirus resources

Promising trial results add to evidence on rotavirus vaccination in Asia Results released this week from a clinical trial of GlaxoSmithKline’s Rotarix™ revealed significant immune responses among Bangladeshi infants given the vaccine. In a study conducted at the International Center for Diarrheal Disease Research, Bangladesh (ICDDR,B), and supported by PATH, 57 to 67 percent of participants receiving the live, oral vaccine developed an immune response, providing critical evidence of the potential impact of rotavirus vaccine introduction in the region. The Phase 2, double-blind, randomized, placebo-controlled study of 300 children was conducted from June 2005 through January 2006. In addition to testing the immunogenicity of Rotarix™ in this setting, investigators at ICDDR,B also evaluated the co-administration of the vaccine with oral polio vaccine (OPV) and found that coadministration did not lower the polio immune response and that Rotarix™ may be administered concomitantly with OPV. Because the performance of oral vaccines can vary in different regions, WHO’s Strategic Advisory Group of Experts (SAGE) has called for appropriately designed clinical trials of rotavirus vaccines among infants in Asia and Africa as a prerequisite to recommending global use. To learn more about additional clinical studies PATH is supporting in Africa and Asia, please see the summary below. Click here to read PATH’s press release on the new study results.
WHO releases updated estimates of global rotavirus disease burden WHO recently announced updated estimates on the number of child deaths worldwide in 2004 that were associated with rotavirus infection: · 527,000 children under five years old died due to rotavirus infection, comprising 29 percent of all diarrhea-related mortality in this age group. · Nearly 85 percent of child rotavirus deaths occurred in Africa and Asia. · 23 percent of all rotavirus deaths under five years of age occurred in India; six countries (India, Nigeria, Democratic Republic of the Congo, Ethiopia, China, and Pakistan) accounted for more than half of under-five rotavirus deaths. An extended summary of the new estimates is available on the WHO website. Check back for future updates to this web page, including country-specific estimates of rotavirus disease burden.
Update on clinical trials in Africa and Asia PATH is working in partnership with Merck & Co., Inc. and GlaxoSmithKline to evaluate the safety and efficacy of their respective rotavirus vaccines in developing countries of Africa and Asia. A Phase 3 study of Merck’s RotaTeq® vaccine began in Bangladesh in early April, with enrollment of the study’s first infant at ICDDR,B. Additional trials with RotaTeq® will begin later this year in Mali, Ghana, Kenya, and Vietnam. A Phase 3 trial of GSK’s Rotarix™ vaccine is ongoing in South Africa and Malawi. At the end of March, investigators in Malawi enrolled the one-thousandth child, bringing the total number of children enrolled at all sites in both countries to more than 4,000. Full participation is anticipated to top 5,000 by the time enrollment is completed on June 30, 2007. European network established with surveillance initiated in four countries The CDC’s latest issue of Rotavirus Surveillance News outlines activities of the European regional surveillance network. Data on the burden of rotavirus in Eastern Europe is particularly important, as the region includes several countries that may be early introducers of rotavirus vaccines subsidized by the GAVI Alliance. With technical assistance from CDC and PATH, surveillance began in December 2006 in Azerbaijan, Georgia, Tajikistan, and Ukraine. Activities in these countries enabled the establishment of a regional network that also incorporates data collected in Kyrgyzstan and Uzbekistan, which had previously initiated rotavirus surveillance. To read more about the European regional rotavirus surveillance network, click here. Learn more about advisory committee review of RotaTeq® vaccine safety in US Presentations from February’s meeting of the CDC’s Advisory Committee on Immunization Practice are now available online. The committee reviewed post-marketing safety surveillance data on RotaTeq®, the rotavirus vaccine by Merck & Co., Inc. Because of a suspected association between intussusception and the RotaShield® vaccine that was withdrawn from the US market in 1999, the CDC is taking particular care to monitor adverse event reports associated with RotaTeq®. The data reveal that cases of intussusception reported since its introduction in early 2006 did not exceed the expected background rate. For a detailed report of the meeting and the committee’s data review, please see the March 16 issue of the Morbidity and Mortality Weekly Report.
Rotavirus resources NEW! Rotavirus Vaccine Program fact sheet NEW! Pan American Health Organization rotavirus page (Spanish) Seattle aid group fights illness, Nicaragua style Seattle Post-Intelligencer; March 7, 2007 PATH Vaccine Resource Library: Rotavirus Rotavirus Vaccine Program website CDC rotavirus page WHO rotavirus page PATH/UNICEF Enhanced Diarrheal Disease Control Resource Center

The PATH Rotavirus Vaccine Program is supported by the GAVI Alliance.

Questions or comments about PATH's rotavirus vaccine program? Contact us at rvpinfo@path.org.