Clinical trials of herpes zoster (HZ) vaccines
Shingles Prevention Study (SPS)27 | Short-Term Persistence Substudy30 | Long-Term Persistence Substudy31 | Zostavax Efficacy and Safety Trial33 | ZOE-5053 | |
---|---|---|---|---|---|
Intervention | 0.5 ml of the live- attenuated Oka/ Merck VZV vaccine or placebo, subcutaneously | None | None | 0.65 ml of the live-attenuated Oka/Merck VZV vaccine or placebo, subcutaneously | 0.5 ml of recombinant VZV glyco-protein E and the AS01B adjuvant system or placebo, intramuscularly |
Number of injections | 1 | 1 | 2.2 months apart | ||
Number of participants | 38.546 | 14.270 SPS participants | 6.867 SPS participants from the vaccine group | 22.439 | 16.160 |
Age, years | 69 (median) | 73.3 (mean) | 74.5 (mean) | 54.9 (mean) | 623 (mean) |
Mean duration of follow-up | 3.13 years | Placebo: 0.98 years Vaccine: 1.36 years | 3.74 years | 1.3 years | 3.2 years |
Efficacy against HZ incidence | 51.3%a | 39.6%a | 21.1%a | 69.8%a | 97.25a |
Efficacy against burden of illness | 61.1%a | 50.1%a | 37.3a | Not reported | Not reported |
Efficacy against postherpetic neuralgia incidence | 66.5%a | 60.1% | 35.4a | Not reported | Not reported |
Injection-site adverse events | Placebo: 17% Vaccine: 48a | Not applicable | Not applicable | Placebo: 14.4% Vaccine: 63.9%a | Placebo: 12% Vaccine: 82%a |
Serious adverse events | Placebo: 1.3% Vaccine: 1.9%a | Not applicable | Not applicable | Placebo: 0.5% Vaccine: 0.6% | Placebo: 8.9% Vaccine: 9.0% |
↵a Statistically significant.
ZOE-50 = Zoster Efficacy Study in Adults 50 Years of Age or Older