- 2026-05-04
- Open forum infectious diseases 13(6)
- Rafael Leon
- Javier Diez-Domingo
- Charles Andrews
- Clovis Arns da Cunha
- Eun-Ju Choo
- David Shu Cheong Hui
- Anthony L Cunningham
- Takashi Eto
- Giancarlo Icardi
- Shelly A McNeil
- Airi Põder
- Pavel Kosina
- Lars Rombo
- Tino F Schwarz
- Juan Carlos Tinoco
- Chong-Jen Yu
- Jing Wang
- Jyoti Soni
- Manyee Tsang
- Ana Strezova
- Bruno Salaun
- Agnes Mwakingwe-Omari
Study Design
- Type
- Clinical Trial
- Sample size
- n = 119
- Population
- participants ≥50 years
- Methods
- randomized to 1 additional dose, 2 additional doses, or no additional vaccination; humoral and cell-mediated immunity evaluated by antiglycoprotein E antibodies, gE-specific CD4[2+] T-cells, and memory B-cells; reactogenicity evaluated for 7 days postvaccination
- Duration
- 6-year follow-up after completion of the primary studies
Background
A phase 3b extension of the ZOE-50/70 trials evaluated long-term efficacy, immunogenicity, and safety of the recombinant zoster vaccine (RZV) in participants ≥50 years, with a 6-year follow-up after completion of the primary studies. A subset of participants was evaluated for immunogenicity and safety of 1 or 2 additional doses administered 5-6 years after primary vaccination.Methods
Participants were randomized to 1 additional dose (1-additional dose group, n = 61), 2 additional doses (revaccination group, n = 60), or no additional vaccination (control, n = 119). Humoral and cell-mediated immunity were evaluated by antiglycoprotein E (gE) antibodies, gE-specific CD4[2+] T-cells, and memory B-cells. Reactogenicity was evaluated for 7 days postvaccination and overall safety was evaluated throughout the study. NCT02723773.Results
Anti-gE geometric mean concentrations (GMCs) were 10 000-11 500 mIU/mL in all groups preadditional vaccination. Geometric mean concentrations peaked at 1 month after 1 dose (73 834.4 and 79 419.8 mIU/mL in the 1-additional dose and revaccination groups, respectively), declined at Year 1, but remained above preadditional vaccination levels thereafter. Geometric mean concentration was 64 603.0 mIU/mL 1 month after the second dose in the revaccination group. Geometric mean concentrations in the control group were 8825.4 mIU/mL at Year 1 and 6858.8 mIU/mL at Year 6. The frequency of gE-specific CD4[2+] T-cells and memory B-cells followed a similar pattern. Pain and fatigue were the most common solicited adverse events. No serious adverse events related to RZV were reported.Conclusions
A single additional RZV dose elicited strong and durable humoral and cell-mediated anamnestic responses, with a reactogenicity and safety profile as established in primary studies.Clinical trial registration
NCT02723773.