Antibody persistence in Chinese toddlers at 1 year and 2 years after two different 4-dose schedules of a novel 13-valent pneumococcal conjugate vaccine (PCV13-TT).

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Tác giả: Jingjing Chen, Huilan Fan, Xuefen Gao, Ruoyu Hu, Zhen Huang, Zhiwei Jiang, Hong Li, Jianxiang Lin, Jing Shi, Lei Shi, Siwen Tao, Zhiqiang Xie, Xuemei Yan, Yemei Yang, Qiang Ye, Lin Yuan, Junyan Yue

Ngôn ngữ: eng

Ký hiệu phân loại: 571.9677 Diseases Pathology

Thông tin xuất bản: Netherlands : Vaccine , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 166729

BACKGROUND: A novel 13-valent pneumococcal conjugate vaccine (PCV13-TT) has been widely used in China since its licensure in 2019. The prelicensure pivotal clinical study (PCV13-002) showed strong immune responses against 13 serotypes with PCV13-TT using two different 3P + 1 schedules starting at either 2 (PCV13-2M) or 3 months (PCV13-3M) of age. METHODS: To assess antibody persistence, healthy Chinese toddlers from PCV13-002 were recalled for blood collection at 1 and 2 years post booster dose. Antibody persistence was evaluated using ELISA and OPA assay methods to measure serotype-specific antibodies. RESULTS: Similar immune responses were noted for both PCV13-3M and PCV13-2M groups. IgG GMCs remained high (ranging from 0.39 to 4.68 μg/mL) through 2 years post 4 doses of PCV13-TT, with IgG positive rates against most serotypes maintained at ≥90%. Both OPA GMTs and OPA positive rates remained high compared to levels observed at 1 month post booster. CONCLUSION: After complete dosing schedule of PCV13-TT starting from either 2 months or 3 months, the antibody level declined through 1 year and 2 years post booster dose, while still remained at relatively high levels at the two timepoints as compared to those observed at 1 month post booster dose for the majority of serotypes. CLINICAL TRIAL REGISTRATION: CTR20182353.
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