IgG, IgM, and Nonstructural Protein 1 Response Profiles after Receipt of Tetravalent Dengue Vaccine TAK-003 in a Phase 2 Randomized Controlled Trial

Am J Trop Med Hyg. 2024 May 28;111(1):102-106. doi: 10.4269/ajtmh.23-0549. Print 2024 Jul 3.

Abstract

The profiles of vaccine-induced dengue antibodies may differ from those produced following natural infection and could potentially interfere with the interpretation of diagnostic tests. We assessed anti-dengue IgG and IgM antibodies, and nonstructural protein 1 antigen profiles in the serum of adults who received a single dose of the tetravalent dengue vaccine TAK-003 as either an initially developed high-dose formulation or the standard approved formulation in a phase 2 study in Singapore (#NCT02425098). Immunoglobulin G and IgM profiles during the first 30 days postvaccination varied by baseline serostatus (microneutralization assay). Nonstructural protein 1 antigen was not detected in the serum of any participants. Vaccine-induced IgG and IgM antibodies can affect serological confirmation of subsequent dengue infection in vaccinees. These results highlight the limitations of using serological tests for dengue diagnosis, particularly in a postvaccination setting, and emphasize the need for more sensitive antigen- and molecular-based testing for accurate dengue diagnosis.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Antibodies, Viral* / blood
  • Dengue Vaccines* / administration & dosage
  • Dengue Vaccines* / immunology
  • Dengue Virus* / immunology
  • Dengue* / diagnosis
  • Dengue* / immunology
  • Dengue* / prevention & control
  • Female
  • Humans
  • Immunoglobulin G* / blood
  • Immunoglobulin M* / blood
  • Male
  • Middle Aged
  • Singapore
  • Viral Nonstructural Proteins* / immunology
  • Young Adult

Substances

  • Dengue Vaccines
  • Immunoglobulin M
  • Immunoglobulin G
  • Viral Nonstructural Proteins
  • Antibodies, Viral