Dengvaxia Generic Name & Formulations
Store lyophilized vaccine antigen and saline diluent in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light.
After reconstitution, administer immediately or store refrigerated at 2°C to 8°C (36°F to 46°F) and use within 30 minutes. Discard reconstituted vaccine if not used within 30 minutes.
Mechanism of Action
Following administration, Dengvaxia elicits dengue-specific immune responses against the 4 dengue virus serotypes. The exact mechanism of protection has not been determined.
Limitations of Use
Dengvaxia Dosage and Administration
Reconstitute Dengvaxia with the supplied diluent.
After reconstitution, administer Dengvaxia by subcutaneous injection immediately or store refrigerated at 2°C to 8°C (36°F to 46°F) and use within 30 minutes.
Dengvaxia Boxed Warnings
Pregnancy exposure registry: Contact, Sanofi Pasteur Inc. at 1-800-822-2463 (1-800-VACCINE) to enroll in or obtain information about the registry.
No specific studies of Dengvaxia have been performed among pregnant women. The potential for transmission of the vaccine virus from mother to infant is unknown.
Nursing Mother Considerations
No data available to assess the impact of Dengvaxia on milk production, its presence in breast milk, or its effect on the breastfed child. Consider the benefits of breastfeeding along with the mother’s need for Dengvaxia and any potential adverse effects on the breastfed child.
Safety and effectiveness of Dengvaxia in children younger than 9 years of age have not been established.
Safety and effectiveness of Dengvaxia in adults 65 years of age and older have not been established.
Dengvaxia Adverse Reactions
Dengvaxia Clinical Trials
The approval of Dengvaxia was based on data from 2 placebo-controlled studies involving over 35,000 patients in dengue-endemic areas. Patients were randomly assigned 2:1 to receive either Dengvaxia or saline placebo and were 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.
Among participants who previously had laboratory-confirmed dengue disease, vaccine efficacy was reported to be 80.6% (95% CI, 50.7-93.2) in Study 1 (9 to 16 years of age) and 77.2% (95% CI, 18.3-94.9) in Study 2 (9 to 14 years of age).
The immunogenicity of concomitantly administered vaccines was evaluated in an open-label study (ClinicalTrials.gov Identifier: (NCT02992418) that included 688 participants (9 to 60 years of age). Participants received Adacel concomitantly with the first dose of Dengvaxia in one group and one month apart in the second group.
Results showed there was no interference in the immune responses to Adacel when concomitantly administered with a first dose of Dengvaxia. There is no information available on the concomitant administration of Adacel and Dengvaxia after the 3-dose vaccination schedule.
In studies that evaluated the occurrence of vaccine viremia systematically at pre-specified timepoints, vaccine viremia was observed following Dengvaxia vaccination in 5.6% of individuals, with 90% of these occurrences documented after the first injection. Vaccine viremia was observed 7 to 14 days after Dengvaxia vaccination with a duration of less than 7 days.
Dengvaxia Patient Counseling
Common adverse reactions that occur within 14 days following administration: Headache, injection site pain, malaise, asthenia, myalgia.
Seek medical care if signs/symptoms of dengue fever develop. Severe dengue warning signs include high fever, severe abdominal pain or tenderness, persistent vomiting, mucosal bleeding, somnolence, and hyperactivity.
Pregnancy registry: Call (800) 822-2463.