- 2026-02-18
- The Pediatric infectious disease journal 45(8)
- Lingxian Qiu
- Hongxing Pan
- Qi Liang
- Zhen Chen
- Minglei Zhang
- Sheng Liu
- Mengjun Liao
- Lu Chen
- Xiaohui Liu
- Jialei Hu
- Changgui Li
- Jiaxue Li
- Jinbo Xu
- Chunlan Zhuang
- Shoujie Huang
- Wei Wang
- Jinle Han
- Jizong Jia
- Xiafei Chu
- Hua Zhu
- Tong Cheng
- Yingying Su
- Xiangzhong Ye
- Yaru Quan
- Ting Wu
- Jun Zhang
- Ningshao Xia
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Population
- Healthy children 1-12 years old (and phase 2a participants 3-12 years old) with no history of varicella infection or vaccination
- Methods
- Randomized, double-blind, controlled, phase 2b clinical trial; children assigned to 0-3-/6-month schedule for low/medium dose; phase 2a participants received second dose in 0-15-month schedule; primary outcome immunogenicity at 30 and 90 days post-second vaccination
- Blinding
- Double-blind
- Funding
- Unclear
Background
Current Oka strain varicella vaccines are generally safe but may cause latent neuronal infections leading to herpes zoster in some vaccinees. A novel v7D candidate vaccine has been developed to prevent varicella and reduce these risks.Methods
This randomized, double-blind, controlled, phase 2b clinical trial was conducted in Jiangsu, China. Healthy children 1-12 years old with no history of varicella infection or vaccination were enrolled and randomly assigned to 0-3-/6-month schedule for low/medium dose. Phase 2a participants (3-12 years of age) previously receiving low-/medium-/high-dose v7D or licensed vOka received a second dose in phase 2b (0-15-month schedule) for exploratory analysis. The primary outcome was immunogenicity via varicella-zoster virus immunoglobulin (Ig)G seroconversion and geometric mean titers at 30 and 90 days post-second vaccination. This study was registered on Chinese Clinical Trial Registry, ChiCTR2300068380.Results
In the per-protocol analysis, IgG antibody response reached 100% seroconversion by day 30 after the second vaccination. Antibody levels were comparable among different vaccine groups under the same schedule at day 30 post-second vaccination. The occurrence of adverse reactions was similar among the different vaccine groups within the same schedule. Most adverse reactions were mild or moderate and resolved shortly. None of the serious adverse events were related to the vaccine.Conclusions
The 2-dose regimens of v7D vaccine demonstrated robust immune responses and excellent safety profiles. These findings warrant further evaluation of the safety advantages and efficacy v7D vaccine in the future.