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The French pharmaceutical company Sanofi said on Monday that its experimental vaccine for dengue fever had succeeded in its first late-stage clinical trial. The results could help pave the way for the introduction of the first vaccine to prevent a disease that afflicts an estimated 50 million to 100 million people a year.
Sanofi said the vaccine reduced the incidence of dengue fever by 56 percent in a trial involving more than 10,000 children in Southeast Asia.
Outside experts said they were hoping for even greater effectiveness, but some said the vaccine could still be useful.
“I’m looking for something that could potentially do better than this,†said Dr. Robert Edelman, clinical professor of medicine and pediatrics at the University of Maryland. He said ideally a vaccine would be 80 percent effective, which would not only protect vaccinated individuals but also reduce transmission to unvaccinated people.
But Duane J. Gubler, a dengue expert at the Duke-NUS Graduate School of Medicine in Singapore, called the results “very encouraging.â€
A spokesman for Sanofi said that since there was no vaccine now, Sanofi’s product might be welcomed by many countries and help many people. “Fifty-six percent has to be compared to zero today,†said the spokesman, Alain Bernal.
Sanofi’s announcement did not contain much detail. The company said it was still analyzing the data and would present more information at a medical conference and in a peer-reviewed publication this year.
“This achievement is the result of more than 20 years of work in the field of dengue, collaborating with investigators, volunteers, authorities, scientific experts and international organizations,†Olivier Charmeil, chief executive of Sanofi Pasteur said in a statement.
Dengue fever is caused by a virus transmitted by mosquitoes. It is common in tropical and subtropical areas and is spreading. While dengue is not a big problem in the United States, the Florida Keys had its first cases in decades in 2009.
The disease, also known as break bone fever, can cause severe fever and intense joint and muscle pain. Serious cases can cause hemorrhagic fever, which is marked by bleeding and shock. These can be fatal, especially to children.
The vaccine is one of the most important products in Sanofi’s pipeline. The company has been trying to compensate for the loss of patent protection on some of its big-selling drugs, particularly the anticoagulant Plavix.
Sanofi’s effort is being closely watched because it is two to three years ahead of others in developing a vaccine. A vaccine is needed because there is no specific treatment for dengue and controlling the mosquitos that transmit the disease can be difficult.
The study, a Phase 3 trial, involved 10,275 children age 2 to 14 in Indonesia, Malaysia, the Philippines, Thailand and Vietnam. Two-thirds received three injections of the vaccine over one year. The other one-third received three injections of placebo.
The main outcome being measured by the trial was the number of confirmed cases of dengue.
Sanofi said the drug’s safety was similar to what had been observed in previous studies.
A spokesman for Sanofi said the company would decide whether to seek regulatory approvals after the results from a second Phase 3 trial in Latin America, in the third quarter.
The results of the new trial are better than disappointing results announced in 2012 for a smaller Phase 2 study involving 4,000 children in Thailand. The vaccine reduced dengue cases by only 30 percent, worse than expected.
The company said that the vaccine had failed to protect against only one of the four subtypes of the virus. Yet that subtype was the most prevalent one in that region during the time of the study.
Dr. Gubler speculated that since the new study covered a larger geographic area, that one subtype did not predominant, allowing the overall vaccine results to be better.
One concern is that in areas with poor health care systems it might be difficult to get people to come for three injections over the course of a year. “In endemic areas they find it difficult to find people a second time around,†said Malcolm Thomas, chief executive of Arbovax. His company, based in Raleigh, N.C., hopes to soon begin human testing on a dengue vaccine that could be administered in a single visit.
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