Data from a phase 3 trial show that Takeda's live-attenuated dengue vaccine provides sustained protection against the mosquito-borne disease, with a favorable safety profile, the Japanese drugmaker said today.

In a news release, Takeda officials said data from the TIDES (Tetravalent Immunization against Dengue Efficacy Study) trial show that two doses of the TAK-003 vaccine, marketed under the name Qdenga, provided 61.2% vaccine efficacy (VE) in preventing virologically confirmed dengue and 84.1% VE in preventing dengue-associated hospitalization after 4.5 years. VE against hospitalization rose to 90.6% 2 years after a booster dose was administered at 4.5 years.

Overall efficacy was seen across all four dengue serotypes, and no new safety signals were reported, the company said. The trial involved more than 20,000 healthy children and adolescents (aged 4 to 16 years) from eight dengue-endemic countries in Latin America.

"Qdenga is the most comprehensively studied dengue vaccine, with more than 60,000 participants globally in the clinical program, and these long-term data highlight the durability of its safety and efficacy profile, across diverse populations worldwide," said Derek Wallace, MD, president of the Global Vaccine Business Unit at Takeda.

Vaccines needed amid global surge in dengue cases

Qdenga was first approved in Indonesia in 2022, and has been authorized in 41 countries, with 18.6 million doses distributed across 11 endemic countries. It's one of two dengue vaccines, along with Sanofi's Dengvaxia, that have been prequalified by the World Health Organization to combat dengue, which has seen a substantial global increase in incidence over the last 5 years. More than 14 million cases were reported across 100 countries in 2024.

Edson Moreira, MD, a senior researcher with Brazil's Oswaldo Cruz Foundation, said the inclusion of Qdenga in Brazil's public vaccination program has reduced symptomatic cases and hospitalizations.

"Brazil, consistently among the countries most impacted by dengue, has contributed to the record-breaking number of dengue cases and rise in severity and deaths," Moreira said. "This surge highlights the urgent need for prevention methods like QDENGA."

The data were presented last week at the annual congress of the World Society for Pediatric Infectious Diseases.

A randomized controlled trial conducted in 18 public hospitals in Kenya finds that the the addition of glucocorticoids to standard care for severe community-acquired pneumonia (CAP) reduced the risk of death by 16%.

For the pragmatic, open-label trial, published last week in the New England Journal of Medicine, a team led by researchers at the Kenya Medical Research Institute assigned adult CAP patients without a clear indication for glucocorticoids to receive either standard care or standard care plus oral low-dose glucocorticoids for 10 days.

Of the 2,180 patients, none required intensive care, 1,089 were assigned to glucocorticoids within 48 hours after hospital admission, and 1,091 were assigned to standard care. The median patient age was 53 years.

"Adjunctive glucocorticoids may reduce mortality among patients with severe community-acquired pneumonia (CAP) in well-resourced settings," the authors wrote. "Whether these drugs are beneficial in low-resource settings with limited diagnostic and treatment facilities is unclear."

Balancing benefits with risk of metabolic complications

By 30 days, 22.6% of glucocorticoid recipients and 26.0% in the standard-care group had died (hazard ratio, 0.84). Rates of adverse and serious adverse events (SAEs) were similar in the two groups.

Although hyperglycemia is mostly controllable, blood glucose monitoring is difficult in overburdened sub-Saharan hospitals.

The trial's pragmatic nature means that the results are likely to be more relevant to patients in sub-Saharan Africa than to those in high-resource settings, the researchers said. "On the basis of our findings, adjunctive glucocorticoids could represent a low cost intervention to reduce the high case fatality associated with CAP in sub-Saharan Africa," they wrote.

In an editorial in the same journal, Arthur Kwizera, MD, of Makerere University College of Health Sciences in Uganda, and Martin Dunser, MD, of Johannes Kepler University in Austria, noted that hyperglycemia (high blood glucose) occurred in 16.6% of glucocorticoid recipients.

"Although hyperglycemia is mostly controllable, blood glucose monitoring is difficult in overburdened sub-Saharan hospitals," they wrote. "As the prevalence of diabetes is increasing across Africa, introducing glucocorticoid therapy without strengthened laboratory and nursing capacity may put patients at risk and requires a nuanced balance of the survival benefits and metabolic complications."