Table 1

Primary and secondary outcomes for KAVI-VZV-001 trial

OutcomeHypothesisOutcome measure
Primary
 Cervical mucosal immune activation after VZV vaccinationVaccination against varicella does not result in elevated immune activation after 12 weeks of immunisation.Change in frequency of cervical CD38+HLA-DR+CD4+ T cells 12 weeks after VZV vaccination compared with baseline
Secondary
 (a) Effector VZV-specific CD8+ T cells at the rectal mucosa after VZV vaccinationVaccination against varicella boosts effector VZV-specific CD8+ T-cell response at rectal mucosa.Change in frequency of rectal VZV-specific IFN-γ-producing CD8+ TEM cells 12 weeks after VZV vaccination compared with baseline.
 (b) Proinflammatory cytokine/chemokine secretion after VZV vaccinationVaccination against varicella does not result in elevated proinflammatory signature after 12 weeks of immunisation.Change in level of proinflammatory cytokines/chemokines in blood, cervix and rectum measured at 12 weeks after VZV vaccination compared with baseline
  • IFN-γ, interferon gamma; VZV, varicella-zoster virus.