Safety and immunogenicity of the recombinant zoster vaccine (LZ901) against herpes zoster in Chinese old people: A phase I trial
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GRAPHICAL ABSTRACT
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PUBLIC SUMMARY
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Approximately one in three individuals will develop herpes zoster (HZ) during their lifetime.
This is a randomised phase I, partly-blinded, dose-escalation trial in healthy adults aged 50–70 years.
This study reports phase I clinical data on a domestically developed recombinant zoster vaccine (LZ901) in China.
Both 50μg and 100μg dose levels of LZ901 caused fewer adverse events than positive-controlled vaccine HZ/su.
LZ901 elicited broad cellular immune responses and pronounced humoral responses.
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ABSTRACT
Despite ongoing efforts to reduce the burden of herpes zoster (HZ), it remains a global health concern. This partly-blinded, randomised controlled, dose-escalation phase I trial (CTR20220088) assessed the safety and immunogenicity of LZ901, an alum-adjuvanted recombinant zoster vaccine developed locally in China. Between Jan 15 and Oct 31, 2022, 80 healthy adults aged 50–70 years without prior varicella/HZ infection or varicella vaccination were equally randomised to receive LZ901 (50μg or 100μg), placebo, or a positive-controlled (HZ/su, Shingrix®). The primary outcome was safety, evaluated by adverse events (AEs) within 30 days after each vaccination and serious adverse events (SAEs) from first vaccination to six months post-vaccination. Exploratory outcomes included immunogenicity, assessed via anti-gE antibody and anti-VZV IgG concentrations, and gE-specific CD4+ and CD8+ T-cell responses. Within 30 days post-full vaccination, the overall incidence of AEs was 55.00% in both LZ901 dose-level groups, lower than that in the positive-controlled group (100.00%); no vaccine-related SAEs were reported. The geometric mean fold-rise of anti-gE antibody was 34.04 (50μg) and 16.88 (100μg), versus 118.99 (positive-controlled) and 1.08 (placebo). CD4+ T-cell responses were observed in 85.00% (50μg) and 95.00% (100μg) of LZ901 recipients, compared with 80.00% in the positive-controlled group. These findings indicated that LZ901 is safe, well tolerated, and immunogenic in older adults, supporting further evaluation of the safety profile and efficacy of LZ901 as a zoster vaccine candidate. -
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REFERENCES
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Tong Y., Zhang S., Shen H., et al. (2026). Safety and immunogenicity of the recombinant zoster vaccine (LZ901) against herpes zoster in Chinese old people: A phase I trial. The Innovation Medicine 4:100183. https://doi.org/10.59717/j.xinn-med.2026.100183
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Tong Y., Zhang S., Shen H., et al. (2026). Safety and immunogenicity of the recombinant zoster vaccine (LZ901) against herpes zoster in Chinese old people: A phase I trial. The Innovation Medicine 4:100183. https://doi.org/10.59717/j.xinn-med.2026.100183
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Figure 1.
Trial profile A total of 88 participants were screened, with 8 excluded (7 met exclusion criteria; 1 withdrew consent), leaving 80 randomized into four groups (N=20 each): 50μg LZ901 vaccine, 100μg LZ901 vaccine, placebo, and HZ/su (positive-controlled). All participants received two injections (Dose 1/Dose 2).
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Figure 2.
The percentage of participants experiencing local and systemic adverse events (AEs)
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Figure 3.
GMCs of anti-gE antibodies and geometric mean titres (GMTs) of anti-VZV antibodies at 30 days post first and full vaccination The analysis was based on the results of gp ELISA and FAMA assay
