General Information

Dengvaxia is a tetravalent vaccine, live, for the prevention of dengue disease caused by serotypes 1 – 4 of the virus.

Dengvaxia is a vaccine indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4. Dengvaxia is approved for use in individuals 9 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.

Limitations of use:

Dengvaxia is not approved for use in individuals not previously infected by any dengue virus serotype or for whom this information is unknown. Those not previously infected are at increased risk for severe dengue disease when vaccinated and subsequently infected with dengue virus. Previous dengue infection can be assessed through a medical record of a previous laboratory-confirmed dengue infection or through serological testing prior to vaccination.

The safety and effectiveness of Dengvaxia have not been established in individuals living in dengue non-endemic areas who travel to dengue endemic areas.

Dengvaxia is supplied as a suspension for subcutaneous administration. The recommended dose is three doses (0.5 mL each) 6 months apart (at month 0, 6, and 12).

Side Effects

Adverse effects associated with the use of Dengvaxia may include, but are not limited to, the following:

headache

injection site pain

malaise

asthenia

myalgia

In persons not previously infected by dengue virus, an increased risk of severe dengue disease can occur following vaccination with Dengvaxia and subsequent infection with any dengue virus serotype. There is no FDA-cleared test available to determine a previous dengue infection.

Clinical Trial Results

The efficacy of Dengvaxia was evaluated in two randomized, observer-blind, placebo controlled, multi-center studies. Study 1 (N=20,869) was conducted in individuals 9 through 16 years of age in four Latin American countries and Puerto Rico; and Study 2 (N=10,275) was conducted in individuals 2 through 14 years of age in five Asia-Pacific countries. A subset of subjects in each study (10% in Study 1; 20% in Study 2) was evaluated for antibodies to dengue virus at the time of enrollment and at later time points. Both studies enrolled subjects irrespective of evidence of previous dengue infection. Subjects were randomized 2:1 to receive either Dengvaxia or saline placebo and were monitored for symptomatic virologically-confirmed dengue (VCD) starting at Day 0. Per protocol vaccine efficacy was assessed beginning 28 days after the third vaccination for 12 months. Efficacy of Dengvaxia against Symptomatic VCD in subjects seropositive for Dengue at baseline from 28 days post-dose 3 for a period of 12 months – Study 1 (Ages 9 through 16 Years) and Study 2 (Ages 9 through 14 Years) was met. In Study 1 there were 7 cases of virus in the active group versus 17 in the placebo group (vaccine efficacy 80.6%). In Study 2 there were 4 cases of virus in the active group versus 9 cases in the placebo group (vaccine efficacy 77.2%).