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
- Peng-Fei Jin
- Ya-Ru Quan
- Shi-Xin Xiu
- Xian-Min Jiang
- Hong-Xing Pan
- Yuan Shen
- Xu-Wen Wang
- Jian Kong
- Wen-Juan Wang
- Xiang Cao
- Kang-Wei Xu
- Min Yang
- Kun Yang
- Wen-Yan Wan
- Kai-Qin Wang
- Li Chen
- Ai-Hua Yao
- Yu-Peng Xue
- Na Wan
- Ming Xu
- Shi-Yao Tao
- Ling Peng
- Fang-Rong Yan
- Chang-Gui Li
- Jing-Xin Li
2025-08-15
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 2+ /CD8 2+ T-cell responses). LZ901 demonstrated non-inferiority to HZ/su (margin > −10%) for both CD4 + and CD8 + T-cell responses. Significantly higher response rates were observed with LZ901 for CD4 2 + T-cell responses (83.0% [117/141] vs 58.1% [79/136]; p < 0.0001) and CD8 2 + 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.