[Translation] A randomized, blinded, controlled phase Ⅰ/Ⅱ clinical trial to evaluate the safety and immunogenicity of a recombinant herpes zoster vaccine (CHO cells) in healthy people aged 40 years and above

（1）Ⅰ期评价不同佐剂剂量重组带状疱疹疫苗（CHO细胞）在40岁及以上健康人群中的安全性和耐受性。（2）Ⅱ期主要目的 1）评价不同佐剂剂量重组带状疱疹疫苗（CHO细胞）在40岁及以上健康人群中的免疫原性，为Ⅲ期临床试验佐剂剂量和免疫程序的选择提供参考依据。 2）评价不同佐剂剂量重组带状疱疹疫苗（CHO细胞）在40岁及以上健康人群中的安全性。次要目的评价不同佐剂剂量重组带状疱疹疫苗（CHO细胞）在40岁及以上健康人群中的免疫持久性。

[Translation]

(1) Phase I To evaluate the safety and tolerability of recombinant herpes zoster vaccine (CHO cells) with different adjuvant doses in healthy people aged 40 years and above. (2) Phase II Main objectives 1) To evaluate the immunogenicity of recombinant herpes zoster vaccine (CHO cells) with different adjuvant doses in healthy people aged 40 years and above, and to provide a reference for the selection of adjuvant doses and immunization schedules in Phase III clinical trials. 2) To evaluate the safety of recombinant herpes zoster vaccine (CHO cells) with different adjuvant doses in healthy people aged 40 years and above. Secondary objectives To evaluate the immune persistence of recombinant herpes zoster vaccine (CHO cells) with different adjuvant doses in healthy people aged 40 years and above.

Start Date16 Feb 2025

Sponsor / Collaborator

Yither biotech (Shanghai) Co., Ltd

[+1]

NCT06851832

/ RecruitingPhase 1/2

A Phase I/II Clinical Trial with Randomized, Blinded, Controlled Design to Evaluate the Safety and Immunogenicity of the Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Populations Aged 40 Years and Older Post -vaccination

The objective of this study was to evaluate the safety, immunogenicity and immune persistence of recombinant herpes zoster vaccine (CHO cells) with different adjuvant doses in healthy people aged 40 years and older.

Start Date16 Feb 2025

Sponsor / Collaborator

Ab&B Bio-Tech Co., Ltd.

[+1]

100 Clinical Results associated with Recombinant Zoster Vaccine ( Zhonghui Yuantong Biological)

100 Translational Medicine associated with Recombinant Zoster Vaccine ( Zhonghui Yuantong Biological)

100 Patents (Medical) associated with Recombinant Zoster Vaccine ( Zhonghui Yuantong Biological)

Literatures (Medical) associated with Recombinant Zoster Vaccine ( Zhonghui Yuantong Biological)

01 Mar 2025·Journal of Medical Virology

Recombinant Zoster Vaccine Reduces All‐Cause Mortality, But Not Major Adverse Cardiovascular Events, in Patients With Immune‐Mediated Inflammatory Diseases Receiving Janus Kinase Inhibitors: A Large‐Scale Real‐World Retrospective Cohort Study

Article

Author: Leong, Pui-Ying ; Shih, Po-Cheng ; Wei, James Cheng-Chung ; Wang, Shiow-Ing ; Huo, An-Ping

ABSTRACTThis study aims to assess the impact of recombinant zoster vaccine (RZV) on the risk of major cardiovascular events (MACE) in patients with rheumatoid arthritis (RA), spondyloarthritis (SpA), or psoriatic diseases who are receiving Janus kinase inhibitors (JAKi). We conducted a new user design study utilizing the TriNetX database. We identified patients diagnosed with RA, SpA, or psoriatic diseases receiving JAKi. Two cohorts were constructed based on RZV vaccination status. Propensity score matching was performed. The primary outcome was MACE, analyzed using Cox regression with hazard ratios (HR) and Kaplan−Meier plots. Subgroup analyses were performed by age, sex, race, and zoster history. Sensitivity analyses were conducted with different follow‐up periods and diseases. Of the 1 528 771 eligible patients initially included, each cohort included 1756 patients after propensity score matching. No significant difference in MACE risk was observed between the two cohorts (HR 1.121, 95% CI: 0.901−1.395). Subgroup and sensitivity analyses were consistent with the main findings. However, RZV vaccination was associated with a significant reduction in all‐cause mortality (HR 0.610, 95% CI: 0.427−0.870). Subgroup analyses indicated that the mortality benefit was particularly evident in females (HR 0.585, 95% CI: 0.379−0.901) and those aged 65 years and older (HR 0.500, 95% CI: 0.301−0.806). In patients with immune‐mediated inflammatory diseases receiving JAKi, RZV vaccination is associated with a 39% reduction in all‐cause mortality compared to unvaccinated individuals. RZV vaccination should be considered for this high‐risk population.

01 Feb 2025·Annals of the Rheumatic Diseases

Effectiveness and safety of the recombinant zoster vaccine in individuals ≥50 years of age with rheumatoid arthritis: a matched cohort and self-controlled case series study

Article

Author: Qian, Lei ; Sy, Lina S ; Solano, Zendi ; Ackerson, Bradley K ; Seifert, Harry ; Wu, Jun ; Oraichi, Driss ; Yun, Huifeng ; Luo, Yi ; Chmielewski-Yee, Elizabeth ; Rayens, Emily ; Tseng, Hung Fu ; De Jesus, Justine ; Florea, Ana ; Cheng, Yanjun ; Ku, Jennifer H ; Lin, Antony T ; Amundsen, Britta

OBJECTIVESIn an interim analysis, we evaluated vaccine effectiveness (VE) against herpes zoster (HZ) and postherpetic neuralgia (PHN) and safety of recombinant zoster vaccine (RZV) in adults aged ≥50 years with rheumatoid arthritis (RA).METHODSVE was assessed using a retrospective matched cohort analysis of Kaiser Permanente Southern California members aged ≥50 years with RA receiving 2 RZV doses (≥4 weeks apart) and matched up to 1:3 to RZV-unvaccinated individuals. Stratified Cox proportional hazards regression was used to estimate adjusted hazard ratios and VE against HZ and PHN. Safety was assessed using a self-controlled case series analysis of chart-confirmed RA flare within 30 days after any RZV vaccination versus comparison periods. The relative risk (RR) was estimated using conditional Poisson regression.RESULTSIn adults ≥50 years with RA (2-dose vaccinated: 1926; unvaccinated: 5746), the adjusted VE of 2 RZV doses against HZ was 60.7% (95% CI, 41.0%-73.8%); in a subgroup analysis among those who received 2 doses 4 weeks to 6 months apart, VE against HZ was 57.9% (95% CI, 34.4%-73.0%). Adjusted VE of 2 RZV doses against PHN was 88.7% (95% CI, 12.1%-98.5%). Among 2606 adults with RA who received ≥1 RZV dose, no increased risk of RA flares within 30 days after RZV vaccination was observed (RR, 1.02; 95% CI, 0.75-1.37).CONCLUSIONSAmong adults ≥50 years with RA, 2 RZV doses provided protection against HZ and PHN. The study did not observe an increased risk of RA flares within 30 days following RZV vaccination.

31 Dec 2024·Human Vaccines & Immunotherapeutics

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

Article

Author: Hongmei, Lu ; Pengfei, Jin ; Zhizhou, Song ; Shan, Zhong ; Qiang, Gao ; Sun, Xiaodong ; Lu, He ; Jing, Wang ; Alexandra Echeverria Proano, Diana ; Hong, Pang ; Soni, Jyoti ; Zhenhui, Xu ; Zoco, Jesús ; Zhuoying, Huang ; Jiaxi, Du ; Xiang, Guo ; Enmao, Cai ; Zhu, Fengcai ; Jia, Li ; Zhi, Li ; Jinyan, Chen ; Parmar, Neeraj ; Qi, Zhu ; Sheng, Liu ; Jiahong, Zhu ; Ali, S. Omar ; Yonggen, Jiang

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.

100 Deals associated with Recombinant Zoster Vaccine ( Zhonghui Yuantong Biological)

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Indication	Highest Phase	Country/Location	Organization	Date
Herpes Zoster	Phase 2	China	Ab&B Bio-Tech Co., Ltd.	16 Feb 2025

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