Merck, PATH to collaborate on rotavirus vaccine trials

By Angela McDaniels

Seattle, Dec. 8 - Merck & Co. Inc. and PATH said they will conduct clinical studies of Rotateq, Merck's investigational rotavirus vaccine, in Africa and Asia. They plan to begin at least one trial by the end of 2006.

Efficacy studies of Rotateq will be conducted in regions where it has not been studied before and where factors such as poor nutrition and the presence of various intestinal bacteria or viruses might play a role in the response to the vaccine, Merck said.

The studies also will assess how Rotateq fits into the range of childhood vaccine schedules used in different countries.

The announcement was made at the Global Alliance for Vaccines and Immunization partners meeting in New Delhi.

Rotavirus is the most common cause of severe dehydrating diarrhea in infants and young children, Merck said. Among children under five, it is responsible for an estimated two million hospitalizations, 500,000 deaths and more than 25 million clinic visits worldwide each year.

"Although rotavirus infection is as common in developed countries as it is in developing nations, most of the children who die from the effects of rotavirus live in countries where emergency medical care, such as intravenous rehydration, is often less readily available," said Adel A.F. Mahmoud, chief medical advisor for vaccines and infectious diseases at Merck, in a company news release.

Rotateq is an oral, liquid vaccine that contains five rotavirus strains: G1, G2, G3, G4 and P1. These serotypes cause most rotavirus disease worldwide.

Merck said it has submitted applications to license Rotateq in more than 50 countries, including the United States and the European Union.

PATH is nonprofit organization based in Seattle that creates sustainable, culturally relevant solutions to cycles of poor health in communities worldwide.

Merck is a pharmaceutical company based in Whitehouse Station, N.J., that develops vaccines and medicines.

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