Vaccine trial results due in Sept

Dr Pratap Singhasivanon, dean of Mahidol University’s Faculty of Tropical Medicine, who oversaw the study, said the Phase II B trial was being conducted since 2009 to test the efficacy of the dengue vaccine among 4,002 children in Ratchaburi province. The Sanofi Pasteur Clinical Study Program developed the vaccine. In the study, about 3,000 of the children were injected with the real vaccine, while the rest were given a placebo. 

A research team will look at how the vaccine generates antibodies against all four serotypes of the virus that is responsible for dengue fever in children. 

“So far, no adverse effects have been reported after the children were given the vaccines. I am quite sure that this vaccine is safe,” he said.

The trial is being held in collaboration with the Mahidol University and International Paediatric Association to curb dengue-related haemorrhagic fever – a leading cause of hospitalisation in Southeast Asia.

During the study period, researchers need to submit reports to the Independent Data Monitoring Committee to evaluate the study before sending it to an ethics committee for approval. 

Once the study is completed, the government will negotiate the price of the vaccine with the company so it can be included in the national healthcare programme. Mahidol University will hold the patent of the study. 

Sanofi Pasteur started developing a dengue vaccine in the 1990s,while clinical studies with the most advanced candidate vaccine began in the 2000s.

Dengue fever is a mosquito-borne disease caused by four types of dengue viruses and is a potential threat for almost half the world’s population. Of the estimated 230 million people infected annually, 2 million, mostly children, develop dengue haemorrhagic fever, a severe form of the disease.

Sanofi has now started conducting its Phase III clinical trial of dengue fever vaccine on 20,000 participants in 10 countries, including Thailand, Vietnam, Malaysia, the Philippines and Indonesia.

In the Phase III trial, the vaccine will be given to children between the ages of two and 14, and results should be revealed in the next two years. 

“We hope that large-scale production of dengue vaccines will begin in 2015, with endemic countries being give the top priority,” Dr Jean Lang, head of Sanofi Pasteur’s Research and Development Dengue Fever programme, said.