» Articles » PMID: 38838170

Efficacy, Reactogenicity, and Safety of the Adjuvanted Recombinant Zoster Vaccine for the Prevention of Herpes Zoster in Chinese Adults ≥ 50 Years: A Randomized, Placebo-controlled Trial

Overview
Date 2024 Jun 5
PMID 38838170
Authors
Affiliations
Soon will be listed here.
Abstract

Phase III multi-country studies (ZOE-50/70) demonstrated that the adjuvanted recombinant zoster vaccine (RZV) was well tolerated and prevented herpes zoster (HZ) in healthy ≥ 50-year-olds, with a vaccine efficacy (VE) > 90% across age groups. These pivotal trials did not enroll participants from mainland China where RZV is licensed, therefore similar clinical data are missing for this population. In this phase IV observer-blind study (NCT04869982) conducted between 2021 and 2023 in China, immunocompetent and medically stable ≥ 50-year-olds were randomized 1:1 to receive two RZV or placebo doses, 2 months apart. This study assessed the VE (overall, as confirmatory objective, and descriptively by age category [50-69-year-olds/≥ 70-year-olds]), reactogenicity, and safety of RZV in this Chinese population. Of the 6138 enrolled participants, 99.2% completed the study. During a mean follow-up period of 15.2 (±1.1) months, 31 HZ episodes were confirmed (RZV = 0; placebo = 31) for an incidence rate of 0.0 vs 8.2 per 1000 person-years and an overall VE of 100% (89.82-100). The descriptive VE was 100% (85.29-100) for 50-69-year-olds and 100% (60.90-100) for ≥ 70-year-olds. Solicited adverse events (AEs) were more frequent in the RZV vs the placebo group (median duration: 1-3 days for both groups). Pain and fatigue were the most frequent local and general AEs (RZV: 72.1% and 43.4%; placebo: 9.2% and 5.3%). The frequencies of unsolicited AEs, serious AEs, potential immune-mediated diseases, and deaths were similar between both groups. RZV is well tolerated and efficacious in preventing HZ in Chinese ≥ 50-year-olds, consistent with efficacy studies including worldwide populations with similar age and medical characteristics.

Citing Articles

A cross-sectional study exploring the predictors of herpes zoster vaccination for people aged over 50 years old in Chaoyang district, Beijing.

Zhang J, Zhang S, Jia B, Bai Y, Li Z, Liu F Front Public Health. 2025; 12:1486603.

PMID: 39917531 PMC: 11799550. DOI: 10.3389/fpubh.2024.1486603.


mRNA Vaccines Against COVID-19 as Trailblazers for Other Human Infectious Diseases.

Brandi R, Paganelli A, DAmelio R, Giuliani P, Lista F, Salemi S Vaccines (Basel). 2025; 12(12.

PMID: 39772079 PMC: 11680146. DOI: 10.3390/vaccines12121418.


Post-Marketing Surveillance of Adverse Events for the Recombinant Zoster Vaccine Among the Population over 50 Years Old in Hangzhou, China.

Wang J, Du J, Liu Y, Xu Y, Han J, Zhang X Vaccines (Basel). 2025; 12(12.

PMID: 39772038 PMC: 11680005. DOI: 10.3390/vaccines12121376.


A prospective, multi-center post-marketing surveillance cohort study to monitor the safety of the recombinant zoster vaccine in Chinese adults ≥50 years of age.

Pang X, Spence O, Parmar N, Wang J, Zhou T, Guo X Hum Vaccin Immunother. 2024; 20(1):2439031.

PMID: 39681337 PMC: 11651282. DOI: 10.1080/21645515.2024.2439031.

References
1.
Cunningham A, Lal H, Kovac M, Chlibek R, Hwang S, Diez-Domingo J . Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older. N Engl J Med. 2016; 375(11):1019-32. DOI: 10.1056/NEJMoa1603800. View

2.
Lecrenier N, Beukelaers P, Colindres R, Curran D, De Kesel C, De Saegher J . Development of adjuvanted recombinant zoster vaccine and its implications for shingles prevention. Expert Rev Vaccines. 2018; 17(7):619-634. DOI: 10.1080/14760584.2018.1495565. View

3.
Kawai K, Gebremeskel B, Acosta C . Systematic review of incidence and complications of herpes zoster: towards a global perspective. BMJ Open. 2014; 4(6):e004833. PMC: 4067812. DOI: 10.1136/bmjopen-2014-004833. View

4.
Sun Y, Kim E, Kong C, Arnold B, Porco T, Acharya N . Effectiveness of the Recombinant Zoster Vaccine in Adults Aged 50 and Older in the United States: A Claims-Based Cohort Study. Clin Infect Dis. 2021; 73(6):949-956. PMC: 8442779. DOI: 10.1093/cid/ciab121. View

5.
Wang G, Yao Y, Wang Y, Gong J, Meng Q, Wang H . Determinants of COVID-19 vaccination status and hesitancy among older adults in China. Nat Med. 2023; 29(3):623-631. PMC: 10285745. DOI: 10.1038/s41591-023-02241-7. View