Table 2:
Study | Study population | Outcomes assessed | Dosing schedule (days in relation to SCT) | Findings |
---|---|---|---|---|
de la Serna et al.73 Recombinant subunit (RZV) Phase 3 observer-blind, placebo controlled, randomized 1:1 Modified cohort: RZV n=870 placebo n=851 median follow up=21 months |
Adult autologous SCT recipients |
Clinical Efficacy (Primary) Safety (Primary) |
2 doses 1: +50 to +70 2: +80 to +130 (or 30 to 60 days after dose 1) |
Incident disease (per person, vaccine vs placebo)
|
Winston et al.74 Heat inactivated VZV vaccine (investigational) Phase 3 double-blind, placebo-controlled, randomized 5:1:5 Vaccine lot n=560 Hi antigen lot n=164 Placebo n=564 Mean follow up=2.4 years |
Adult autologous SCT recipients 2010–2013 135 centers |
Clinical Efficacy (Primary) Safety (Primary-hi lot group) Immunogenicity (Secondary) |
4 doses 1: −5 to −60 2:+30 3:+60 4:+90 |
Incident disease (per 1000 person-years, vaccine lot vs placebo):
VZV-specific responses higher in vaccine group; T cell responses sustained at 3 years; B cell responses plateau after 1 year |
HZ, herpes zoster; PHN, post herpetic neuralgia