Ashleigh McGirr1, Robyn Widenmaier2, Desmond Curran3, Emmanuelle Espié3, Tomas Mrkvan3, Lidia Oostvogels3, Benedetto Simone4, Janet E McElhaney5, Heather Burnett6, Katrin Haeussler7, Adriana Thano8, Xuan Wang9, Rachel S Newson8. 1. GSK Canada, 7333 Mississauga Rd N, Mississauga, ON L5N 6L4, Canada. Electronic address: ashleigh.a.mcgirr@gsk.com. 2. GSK Canada, 7333 Mississauga Rd N, Mississauga, ON L5N 6L4, Canada. 3. GSK, 20 Avenue Fleming, Wavre 1300, Belgium. 4. GSK, Stockley Park West, 1-3 Ironbridge Road, Uxbridge, Middlesex UB11 1BT, United Kingdom. 5. Health Sciences North Research Institute, 41 Ramsey Lake Road, Sudbury P3E 5J1, Canada. 6. Evidera, 7575 Trans-Canada Hwy, Suite 404, St-Laurent, Quebec H4T 1V6, Canada. 7. ICON plc, Konrad-Zuse-Platz 11, 81829 München, Germany. 8. ICON plc, De Molen 84, Houten 3995 AX, the Netherlands. 9. ICON plc, Klarabergsviadukten 90 Hus D, Stockholm 111 64, Sweden.
Abstract
BACKGROUND: We estimated the relative efficacy and safety of vaccines for prevention of herpes zoster (HZ) using network meta-analysis (NMA) based on evidence from randomized controlled trials. METHODS: A systematic literature review evaluated two different HZ vaccines: adjuvanted recombinant zoster vaccine (RZV) and zoster vaccine live (ZVL), with different formulations assessed. Detailed feasibility assessment indicated that a NMA was feasible for efficacy (incidence of HZ and postherpetic neuralgia [PHN]) and safety (serious adverse events [SAE] and reactogenicity [injection-site reactions, systemic reaction]) outcomes. Primary analyses included frequentist NMAs with fixed effects for efficacy outcomes, due to limited data availability, and both fixed and random effects for safety and reactogenicity outcomes. As age is a known effect modifier of vaccine efficacy (VE), VE analyses were stratified by age. RESULTS: RZV demonstrated significantly higher HZ efficacy than ZVL in adults ≥60 years of age (YOA) (VERZV = 0.92 (95% confidence interval [95%CI]: 0.88, 0.94), VEZVL = 0.51 (95%CI: 0.44, 0.57)) and adults ≥70 YOA (VERZV = 0.91 (95%CI: 0.87, 0.94), VEZVL = 0.37 (95%CI: 0.25, 0.48)). Similarly, RZV demonstrated significantly higher PHN efficacy than ZVL in adults ≥60 YOA (VERZV = 0.89 (95%CI: 0.70, 0.96), VEZVL = 0.66 (95%CI: 0.48, 0.78)) and adults ≥70 YOA (VERZV = 0.89 (95%CI: 0.69, 0.96), VEZVL = 0.67 (95%CI: 0.44, 0.80)). RZV was associated with significantly more injection-site and systemic reactions compared to most formulations of ZVL and placebo, however definitions and data collection procedures differed across the included studies. There were no statistically significant differences found between RZV and any formulation of ZVL or placebo for SAEs. CONCLUSION: RZV is significantly more effective in reducing HZ and PHN incidence in adults ≥60 YOA, compared with ZVL. As anticipated with an adjuvanted vaccine, RZV results in more reactogenicity following immunization. No differences in SAEs were found between RZV and ZVL.
BACKGROUND: We estimated the relative efficacy and safety of vaccines for prevention of herpes zoster (HZ) using network meta-analysis (NMA) based on evidence from randomized controlled trials. METHODS: A systematic literature review evaluated two different HZ vaccines: adjuvanted recombinant zoster vaccine (RZV) and zoster vaccine live (ZVL), with different formulations assessed. Detailed feasibility assessment indicated that a NMA was feasible for efficacy (incidence of HZ and postherpetic neuralgia [PHN]) and safety (serious adverse events [SAE] and reactogenicity [injection-site reactions, systemic reaction]) outcomes. Primary analyses included frequentist NMAs with fixed effects for efficacy outcomes, due to limited data availability, and both fixed and random effects for safety and reactogenicity outcomes. As age is a known effect modifier of vaccine efficacy (VE), VE analyses were stratified by age. RESULTS:RZV demonstrated significantly higher HZ efficacy than ZVL in adults ≥60 years of age (YOA) (VERZV = 0.92 (95% confidence interval [95%CI]: 0.88, 0.94), VEZVL = 0.51 (95%CI: 0.44, 0.57)) and adults ≥70 YOA (VERZV = 0.91 (95%CI: 0.87, 0.94), VEZVL = 0.37 (95%CI: 0.25, 0.48)). Similarly, RZV demonstrated significantly higher PHN efficacy than ZVL in adults ≥60 YOA (VERZV = 0.89 (95%CI: 0.70, 0.96), VEZVL = 0.66 (95%CI: 0.48, 0.78)) and adults ≥70 YOA (VERZV = 0.89 (95%CI: 0.69, 0.96), VEZVL = 0.67 (95%CI: 0.44, 0.80)). RZV was associated with significantly more injection-site and systemic reactions compared to most formulations of ZVL and placebo, however definitions and data collection procedures differed across the included studies. There were no statistically significant differences found between RZV and any formulation of ZVL or placebo for SAEs. CONCLUSION:RZV is significantly more effective in reducing HZ and PHN incidence in adults ≥60 YOA, compared with ZVL. As anticipated with an adjuvanted vaccine, RZV results in more reactogenicity following immunization. No differences in SAEs were found between RZV and ZVL.
Authors: Dawid Pieper; Irma Hellbrecht; Linlu Zhao; Clemens Baur; Georgia Pick; Sarah Schneider; Thomas Harder; Kelsey Young; Andrea C Tricco; Ella Westhaver; Matthew Tunis Journal: Syst Rev Date: 2022-08-22
Authors: Brandon J Patterson; Philip O Buck; Desmond Curran; Desirée Van Oorschot; Justin Carrico; William L Herring; Yuanhui Zhang; Jeffrey J Stoddard Journal: Mayo Clin Proc Innov Qual Outcomes Date: 2021-05-26