DENGVAXIA

Dengvaxia Generic Name & Formulations

Legal Class

General Description

Dengue tetravalent vaccine, live; susp for SC inj after reconstitution (contains 4.5–6.0 log10CCID50 of each chimeric yellow fever dengue (CYD) virus serotypes 1, 2, 3, 4); per 0.5mL; preservative-free.

How Supplied

Single-dose vial—1 (w. diluent)

Storage

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.

Manufacturer

Sanofi Pasteur, Inc.

Generic Availability

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.

Dengvaxia Indications

Indications

Immunization against dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 9–16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.

Limitations of Use

Not for use if not previously infected by any dengue virus serotype or for whom this information is unknown. Safety and efficacy have not been established in individuals living in dengue non-endemic areas who travel to dengue endemic areas.

Dengvaxia Dosage and Administration

Adult

>16yrs: not established.

Children

<9yrs: not established. Give by SC inj only. ≥9yrs to ≤16yrs: one 0.5mL dose at month 0, 6, and 12.

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 Contraindications

Contraindications

Severe immunodeficiency or immunosuppression due to disease or therapy.

Dengvaxia Boxed Warnings

Not Applicable

Dengvaxia Warnings/Precautions

Warnings/Precautions

Increased risk of severe dengue infection following Dengvaxia if not previously infected by dengue virus. Evaluate for prior dengue infection; avoid vaccination if not previously infected or unknown. Have appropriate medical treatment and supervision available to manage allergic reactions. Limitations of vaccine effectiveness; advise to continue personal protection measures against mosquito bites after vaccination. Labor & delivery. Pregnancy. Nursing mothers.

Pregnancy Considerations

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.

Pediatric Considerations

Safety and effectiveness of Dengvaxia in children younger than 9 years of age have not been established.

Geriatric Considerations

Safety and effectiveness of Dengvaxia in adults 65 years of age and older have not been established.

Dengvaxia Pharmacokinetics

See Literature

Dengvaxia Interactions

Interactions

Immunosuppressants (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, high-dose steroids) may reduce immune response to Dengvaxia. May cause false (–) results of tuberculin purified protein derivative (PPD) test sensitivity; give tuberculin test before or ≥1month after Dengvaxia vaccine.

Dengvaxia Adverse Reactions

Adverse Reactions

Headache, inj site pain, malaise, asthenia, myalgia; hypersensitivity reactions, syncope.

Dengvaxia Clinical Trials

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 Note