Immunogenicity and safety of a recombinant gE-Fc fusion protein subunit vaccine for herpes zoster in adults ≥50 years of age: a randomised, active-controlled, non-inferiority trial
The licensed adjuvanted recombinant glycoprotein E (gE) subunit vaccine (HZ/su) is highly effective against herpes zoster (HZ). This randomised, active-controlled, non-inferiority trial (ChiCTR2300079076) compared the immunogenicity and safety of a novel gE-Fc fusion protein vaccine candidate (LZ901) with HZ/su in 300 healthy adults aged ≥50 years without prior HZ vaccination in Wuxi, China. Participants received either two doses of LZ901 (30-day interval; n = 151) or HZ/su (60-day interval; n = 149). The primary outcomes was the proportion of participants with simultaneous positive responses to two or more cytokines (IFN-γ, IL-2, TNF-α, or CD40L) 30 days after the second dose (referred to as gE-specific CD4<sup>2+</sup>/CD8<sup>2+</sup> T-cell responses). LZ901 demonstrated non-inferiority to HZ/su (margin > -10%) for both CD4<sup>+</sup> and CD8<sup>+</sup> T-cell responses. Significantly higher response rates were observed with LZ901 for CD4<sup>2</sup> + T-cell responses (83.0% [117/141] vs 58.1% [79/136]; p < 0.0001) and CD8<sup>2</sup> + T-cell responses (46.8% [66/141] vs 8.8% [12/136]; p < 0.0001). Adverse reactions were markedly lower with LZ901 (41.1% [62/151] vs 87.9% [131/149]; p < 0.0001), including grade 3 events (0.7% [1/151] vs 6.0% [9/149]). LZ901 induced superior cellular immunogenicity and exhibited a better safety profile than HZ/su in adults ≥50 years, supporting its potential as a promising HZ prevention candidate vaccine.
Authors
- Wen-Yan Wan (ORCID: https://orcid.org/0000-0001-8938-5530)
- Xiang Cao (ORCID: https://orcid.org/0000-0002-7635-4767)
- Min Jae Yang (ORCID: https://orcid.org/0000-0001-5039-8182)
- Na Wan
- Xu‐Wen Wang (ORCID: https://orcid.org/0000-0001-7670-3544)
- Hongxing Pan (ORCID: https://orcid.org/0000-0002-3791-1241)
- Ke Wang (ORCID: https://orcid.org/0000-0001-6776-4935)
- Jingxin Li (ORCID: https://orcid.org/0000-0002-7033-5151)
- Changgui Li (ORCID: https://orcid.org/0000-0002-9660-0216)
- Aihua Yao (ORCID: https://orcid.org/0000-0001-8013-0339)
- Ming Xu (ORCID: https://orcid.org/0000-0001-8846-2880)
- Yaru Quan
- Fangrong Yan (ORCID: https://orcid.org/0000-0003-3347-5021)
- Pengfei Jin (ORCID: https://orcid.org/0000-0002-8908-2633)
- Shixin Xiu (ORCID: https://orcid.org/0009-0007-4919-8790)
- Li Chen (ORCID: https://orcid.org/0000-0001-8492-1963)
- Wenjuan Wang (ORCID: https://orcid.org/0000-0003-3863-9937)
- Kun Yang (ORCID: https://orcid.org/0000-0002-1913-9585)
- Xiaomeng Jiang (ORCID: https://orcid.org/0009-0001-3740-3351)
- Jian Kong
- Yang Xue (ORCID: https://orcid.org/0000-0002-5258-7363)
- Tao Sun (ORCID: https://orcid.org/0000-0002-6066-5915)
- Yuan Shen
- L. Peng
- Kang-Wei Xu
Institutions
- China Pharmaceutical University (CN)
- Yunnan University (CN)
- Beijing VDJBio (China) (CN)
- Zhongda Hospital Southeast University (CN)
- Jiangsu Provincial Center for Disease Control and Prevention (CN)
- National Institutes for Food and Drug Control (CN)
- Wuhan Center for Disease Control and Prevention (CN)
- Nanjing Medical University (CN)
Publication Details
- Journal
- Nature Communications
- Published
- 2025-08-15
- DOI
- https://doi.org/10.1038/s41467-025-62800-z
- Citations
- 1
- Primary Topic
- Herpesvirus Infections and Treatments
- Type
- article
- Field-Weighted Citation Impact
- 1.35
Funders
- National Key Research and Development Program of China