An Exploratory Study of the Salivary Immunoglobulin A Responses to 1 Dose of a Norovirus Virus-Like Particle Candidate Vaccine in Healthy Adults

J Infect Dis. 2019 Jan 9;219(3):410-414. doi: 10.1093/infdis/jiy529.

Abstract

As noroviruses are transmitted through the fecal-oral route, we investigated humoral and mucosal (salivary immunoglobulin A [IgA]) immune responses in a phase 2 trial of Takeda's bivalent norovirus virus-like particle (VLP) vaccine candidate in 50 healthy 18- to 49-year-olds. The vaccine had an acceptable tolerability profile and induced rapid, robust humoral immune responses after 1 intramuscular dose of vaccine candidate. Seroresponses were evident 8 days after vaccination as panimmunoglobulin, IgA, and histo-blood group antigen-blocking antibodies against both vaccine GI.1 and GII.4c genotypes. Salivary IgA levels were approximately 1000-fold lower than serum concentrations, and moderately or strongly correlated with the serum IgA titers at all time-points.

Trial registration: ClinicalTrials.gov NCT02475278.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Adolescent
  • Adult
  • Blood Group Antigens
  • Female
  • Genotype
  • Humans
  • Immunity, Humoral
  • Immunogenicity, Vaccine
  • Immunoglobulin A / blood
  • Immunoglobulin A / immunology*
  • Male
  • Middle Aged
  • Norovirus / immunology*
  • Saliva / immunology*
  • Vaccination
  • Vaccines, Virus-Like Particle / immunology*
  • Viral Vaccines / administration & dosage
  • Viral Vaccines / immunology*
  • Young Adult

Substances

  • Blood Group Antigens
  • Immunoglobulin A
  • Vaccines, Virus-Like Particle
  • Viral Vaccines

Associated data

  • ClinicalTrials.gov/NCT02475278