title: Immunogenicity and safety of two live-attenuated tetravalent dengue vaccine formulations in healthy Australian adults.
abstract: We conducted a Phase 1b study to evaluate the immunogenicity and safety of two live attenuated tetravalent dengue vaccines in healthy adult volunteers. After one injection, all subjects reported systemic reactions consistent with a mild dengue-like syndrome. Seven volunteers developed dengue 3 viraemia after vaccination. All subjects developed a neutralizing antibody response against serotype 3 with partial response against other serotypes. The trial was stopped early (after 10 subjects enrolled) due to formulation issues, which were related to the dengue 3 vaccine component. Managing viral interference and balancing attenuation to produce acceptable tetravalent immunogenicity with minimal reactogenicity may be a recurring problem for future multivalent live vaccines.
authors.affiliation: Centre for Military and Veterans Health, Mayne Medical School, Herston, Queensland 4006, Australia. s.kitchener@uq.edu.au
authors.forename: Scott
authors.initials: S
authors.lastname: Kitchener
authors.forename: Michael
authors.initials: M
authors.lastname: Nissen
authors.forename: Peter
authors.initials: P
authors.lastname: Nasveld
authors.forename: Remi
authors.initials: R
authors.lastname: Forrat
authors.forename: Sutee
authors.initials: S
authors.lastname: Yoksan
authors.forename: Jean
authors.initials: J
authors.lastname: Lang
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Saluzzo
mesh_terms: D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D001315:Australia; D003715:Dengue / Q000503:physiopathology / Q000517:prevention & control*; D003716:Dengue Virus / Q000276:immunology*; D006801:Humans; D008297:Male; D008889:Military Personnel; D009500:Neutralization Tests; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D014765:Viral Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D014766:Viremia
chemical_list: D000914:Antibodies, Viral; D014613:Vaccines, Attenuated; D014765:Viral Vaccines