What is the role of vaccination in the prevention of dengue?

Updated: May 03, 2019
  • Author: Darvin Scott Smith, MD, MSc, DTM&H; Chief Editor: Michael Stuart Bronze, MD  more...
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Answer

One vaccine is currently approved for the prevention of dengue infection. Sanofi Pasteur registered Dengvaxia (CYD-TDV), a live recombinant tetravalent vaccine, in several countries in late 2015-2016, with Mexico being the initial country to register the vaccine in December 2015. The vaccine is given in 3 doses at age 0, 6, and 12 months. It underwent testing in more than 30,000 volunteers and was shown to reduce the risk of severe illness and hospitalization by as much as 30% in individuals previously infected with one or more strains. The vaccine proved less effective in persons who were not previously exposed to dengue and in areas with a lower burden of disease. [88] Owing to concern that the vaccine may act like an initial dengue infection in this second group of individuals not previously infected with the virus, with additional exposure to a second serotype placing these individuals at increased risk of severe dengue, the WHO released a position paper in July 2016, stating that countries should consider introduction of vaccine as a part of an comprehensive dengue control strategy only where epidemiologic data indicate a high burden of disease. [89]

In April 2018, the WHO’s Strategic Advisory Group of Experts recommended that rapid diagnostic tests to establish serostatus be developed so that prevaccination screening might be used to assess serostatus before CYD-TDV vaccine is administered. [90] As of late 2018, the CYD-TDV vaccine had been approved for use and was being marketed in European endemic areas to persons aged 9-45 years with prior exposure to the disease. [91]

Dengue vaccine was approved by the FDA in 2019 for prevention of dengue disease caused by dengue virus serotypes 1, 2, 3, and 4 in individuals aged 9-16 years with laboratory-confirmed previous dengue infection who live in endemic areas. It is approved only in individuals previously infected by any dengue virus serotype or in whom this information is unknown. Persons not previously infected are at an increased risk of severe dengue disease when vaccinated and subsequently infected with dengue virus.

The approval was based on data from 2 placebo-controlled studies in patients (n > 35,000) living in dengue-endemic areas. Patients were randomized 2:1 to receive either the vaccine or saline placebo and monitored for symptomatic virologically confirmed dengue (VCD) starting at day 0. Vaccine efficacy was assessed beginning 28 days after the third vaccination for 12 months. The vaccine was approximately 76% effective in preventing symptomatic VCD disease among patients aged 9-16 years who were seropositive for dengue at baseline. [92]


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