What are the recommendations for the dengue vaccine (Dengvaxia)?

Recommendations for the Dengue Vaccine (Dengvaxia)

The dengue vaccine (Dengvaxia) is recommended only for children and adolescents aged 9-16 years with laboratory evidence of previous dengue infection who live in dengue-endemic areas of the United States and its territories. 1

Patient Selection Criteria

The Advisory Committee on Immunization Practices (ACIP) has established specific guidelines for Dengvaxia administration:

• Age requirement: Only for children and adolescents aged 9-16 years 2, 1
• Prior infection requirement: Must have laboratory evidence of previous dengue infection 1
• Geographic requirement: Must live in dengue-endemic areas of the US and its territories, including:
  • Puerto Rico
  • American Samoa
  • US Virgin Islands
  • Federated States of Micronesia
  • Republic of Marshall Islands
  • Republic of Palau 1

Rationale for Restricted Use

The restricted recommendation is based on critical safety concerns:

• Dengvaxia is associated with an increased risk of severe dengue in individuals experiencing their first natural dengue infection after vaccination 1
• In clinical trials, breakthrough dengue hospitalizations occurred continuously over 4-5 years post-vaccination in children who were seronegative at the time of vaccination 3
• The vaccine should not be administered to children traveling to or visiting endemic dengue areas who don't live in these regions 2

Testing Requirements Before Vaccination

• Laboratory confirmation of previous dengue infection is mandatory before vaccination 1
• Testing should be performed using a highly specific serodiagnostic test for anti-DENV immunoglobulin G 1
• Lack of laboratory confirmation of previous dengue virus infection is a contraindication to vaccination 2

Vaccine Efficacy

When administered to appropriate candidates (seropositive individuals):

• Dengvaxia is effective in reducing dengue-related hospitalizations and severe dengue 1
• In phase 3 trials in Latin America and Asia involving over 30,000 children and adolescents, the three-dose regimen showed protective efficacy against virologically-confirmed dengue of 60.8% and 56.5% respectively 4
• The vaccine provided protection against severe dengue and dengue hemorrhagic fever in children aged 9 years and older 4

Safety Profile

• Generally well-tolerated in seropositive individuals with no safety concerns identified after up to 4 years of follow-up 4
• Not recommended during pregnancy 2
• Should not be administered to seronegative individuals due to increased risk of severe dengue 3

Alternative Vaccines

• A second dengue vaccine (Qdenga by Takeda) has been approved in some countries but has limitations in seronegative individuals, particularly against DENV-3 and DENV-4 serotypes 5
• New vaccine candidates lacking antibody-dependent enhancement (ADE) are in development 5
• The NIH has developed a live attenuated tetravalent dengue vaccine (TV003/TV005) that may be suitable for dengue-naïve individuals and young children 6

Practical Implementation

• The dengue vaccine should be considered as part of an integrated disease prevention strategy in high dengue-endemic regions 4
• Patient education should include information on protecting themselves from mosquito exposure to prevent transmission 7
• The CDC has updated its immunization schedule to indicate that dengue vaccination is recommended for some children and adolescents aged 9-16 years (purple designation in the immunization schedule) 2

Common Pitfalls to Avoid

• Do not administer to seronegative individuals: This can increase the risk of severe dengue disease through antibody-dependent enhancement 1, 3
• Do not use for travelers: The vaccine is not indicated for travelers visiting endemic areas 2
• Do not confuse with diagnostic testing: In cases of suspected acute dengue, appropriate diagnostic testing includes NAAT and IgM antibody testing, not vaccination 2
• Do not administer without laboratory confirmation: Vaccination without confirmed previous infection can lead to severe adverse outcomes 1, 3

The dengue vaccine represents an important advance in preventing dengue disease, but its use must be carefully restricted to the appropriate population to ensure safety and efficacy.