Progress in the Development of Single-Dose Dengue Vaccines

A Promising Leap in Dengue Vaccine Research

Researchers have identified the need for a single-dose vaccine that can protect against all four dengue virus serotypes, regardless of the individual's dengue baseline serostatus and age. These findings are summarized in a new Quick Take video.

Butantan DV: A Groundbreaking Single-Dose Dengue Vaccine

A single dose dengue vaccine known as Butantan DV, produced by the Butantan Institute in Brazil, has shown promising results. According to a study published in The New England Journal of Medicine, the vaccine has protected 79.6% of those vaccinated. It has proven to be safe and effective for all age groups between 2 and 59, and for people with or without a prior history of dengue virus infection. The ongoing Phase 3 trial, involving 16,235 participants, has demonstrated an overall efficacy of 79.6%. Moreover, the vaccine has been found to induce a balanced antibody production response and is extremely safe for people who have never had dengue.

Anticipated Impact and Expected Approval

The Butantan DV vaccine is expected to significantly reduce mortality and hospitalizations due to dengue in Brazil, where the disease is considered hyperendemic. The vaccine is currently being developed by researchers at 16 Brazilian centers and is anticipated to be approved by 2025. The vaccine is predicted to be submitted for registration in the second half of this year, with potential approval in 2025.

TV005: Another Single-Dose Dengue Vaccine in Development

Another single-dose live attenuated tetravalent dengue vaccine, TV005, is also under development. A study evaluating the efficacy of TV005 against infection with dengue serotype 2 and 3 using controlled human infection models has shown promising results. TV005 protected all vaccinated volunteers from viremia and rash during challenges with DENV2 or DENV3. The study also underscores the importance of controlled human infection models (CHIMs) in assessing vaccine efficacy for all four serotypes of the dengue virus.

Broader Applications and Future Prospects

The Butantan Institute's dengue vaccine has shown protection for 73.6% of participants with no evidence of prior infection and 89.2% of those previously exposed to the virus. It has also proved extremely safe for people who have never had dengue, can be administered to a broader age group, and a single dose is sufficient. The tetravalent dengue vaccine development began in 2010 with the support of FAPESP, and the Phase 3 trial is set to end in June 2023.

Butantan-DV: Tetravalent and Effective

The Butantan-DV, a tetravalent vaccine containing antigens from four strains of the dengue fever virus, exhibited an efficacy of 79.6 percent in clinical trials. The study measured efficacy against two of the four known dengue serotypes. Efficacy was higher (89.2 percent) in participants who had a history of exposure to the virus. Butantan expects to complete the final phase of the research later this year and aims to submit an approval request to the federal health regulator Anvisa. The vaccine could potentially be used in a campaign in 2025.

Implications of Single-Dose Vaccines

The development and success of single-dose vaccines like Butantan DV and TV005 not only offer hope for effective control of dengue but also provide a model for the development of vaccines against other similar diseases. As research progresses and these vaccines move closer to approval, the world is inching closer to a future where dengue can be effectively controlled and prevented.