Hong-Xing Pan, Ling-Xian Qiu, Qi Liang, Zhen Chen, Ming-Lei Zhang, Sheng Liu, Guo-Hua Zhong, Kong-Xin Zhu, Meng-Jun Liao, Jia-Lei Hu, Jia-Xue Li, Jin-Bo Xu, Yong Fan, Yue Huang, Ying-Ying Su, Shou-Jie Huang, Wei Wang, Jin-Le Han, Ji-Zong Jia, Hua Zhu, Tong Cheng, Xiang-Zhong Ye, Chang-Gui Li, Ting Wu, Feng-Cai Zhu, Jun Zhang, Ning-Shao Xia
BACKGROUND: The Oka varicella vaccine strain remains neurovirulent and can establish lifelong latent infection, raising safety concerns about vaccine-related herpes zoster. In this study, we aimed to evaluate the immunogenicity and safety of a skin-attenuated and neuro-attenuated varicella vaccine candidate (v7D vaccine). METHODS: We did this randomised, double-blind, controlled, phase 2a clinical trial in Jiangsu, China. Healthy children aged 3-12 years with no history of varicella infection or vaccination were enrolled and randomly assigned (1:1:1:1) to receive a single subcutaneous injection of the v7D vaccine at 3·3 log10 plaque forming units (PFU; low-dose v7D group), 3·9 log10 PFU (medium-dose v7D group), and 4·2 log10 PFU (high-dose v7D group), or the positive control varicella vaccine (vOka vaccine group)...
April 10, 2024: Lancet Infectious Diseases