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)

31 Pages Posted: 26 Nov 2024

See all articles by Qiang Ye

Qiang Ye

affiliation not provided to SSRN

Hong Li

Government of the People's Republic of China - National Institutes for Food and Drug Control

Zhiqiang Xie

Henan Provincial Center for Disease Control Prevention

Xuefen Gao

affiliation not provided to SSRN

Lin Yuan

Walvax Biotechnology Co Ltd

Jing-Jing Chen

Guangzhou Medical University - State Key Laboratory of Respiratory Disease

Hui-Lan Fan

affiliation not provided to SSRN

Xue-Mei Yan

affiliation not provided to SSRN

Si-Wen Tao

affiliation not provided to SSRN

Yemei Yang

affiliation not provided to SSRN

Junyan Yue

affiliation not provided to SSRN

Jing Shi

affiliation not provided to SSRN

Jianxiang Lin

affiliation not provided to SSRN

Zhiwei Jiang

Beijing Key Tech Statistics Technology Co., Ltd.; Beijing Key Tech Statistics Technology Co., Ltd.

Ruoyu Hu

affiliation not provided to SSRN

Lei Shi

affiliation not provided to SSRN

Zhen Huang

affiliation not provided to SSRN

Abstract

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. Method 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. Result Similar immune responses were noted for both PCV13-3M and PCV13-2M group. IgG GMCs remained high (ranging from 0.39-4.68 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.

Note:
Funding declaration: Yuxi Walvax Biotechnology Co., Ltd. and Walvax Biotechnology Co., Ltd. funded the study.

Conflict of Interests: LY, JC, HF, XY, ST, YY, JY, JS, JL, RH, LS and ZH report being employees of Walvax Biotechnology Co., Ltd. Other authors declare no conflict of interest.

Ethical Approval: This study along with its corresponding documents including study protocol, informed consent from, etc., were approved by the National Medical Products Administration (NMPA) and the Institutional Review Board (IRB) of study sites (Shanxi Provincial Center for Disease Control and Prevention and Henan Provincial Center for Disease Control and Prevention). Investigators informed the subjects’ parents or legal guardians of all aspects pertaining to the subjects’ participation in the study. Before any study procedure was initiated, parents or legal guardians provided written informed consent for the subject to participate into the study.

Trial Registration: The current study (PCV13-003), an extension study of the pivotal phase III clinical trial (PCV13-002, NCT02736240). The study was registered on http://www.chinadrugtrials.org.cn/ as CTR20182353.

Keywords: pneumococcal conjugate vaccines, China, pneumococcal serotypes, antibody persistence

Suggested Citation

Ye, Qiang and Li, Hong and Xie, Zhiqiang and Gao, Xuefen and Yuan, Lin and Chen, Jing-Jing and Fan, Hui-Lan and Yan, Xue-Mei and Tao, Si-Wen and Yang, Yemei and Yue, Junyan and Shi, Jing and Lin, Jianxiang and Jiang, Zhiwei and Hu, Ruoyu and Shi, Lei and Huang, Zhen, 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). Available at SSRN: https://ssrn.com/abstract=5025103 or http://dx.doi.org/10.2139/ssrn.5025103

Qiang Ye

affiliation not provided to SSRN ( email )

No Address Available

Hong Li

Government of the People's Republic of China - National Institutes for Food and Drug Control ( email )

China

Zhiqiang Xie

Henan Provincial Center for Disease Control Prevention ( email )

Xuefen Gao

affiliation not provided to SSRN ( email )

No Address Available

Lin Yuan

Walvax Biotechnology Co Ltd ( email )

Jing-Jing Chen

Guangzhou Medical University - State Key Laboratory of Respiratory Disease ( email )

Hui-Lan Fan

affiliation not provided to SSRN ( email )

No Address Available

Xue-Mei Yan

affiliation not provided to SSRN ( email )

No Address Available

Si-Wen Tao

affiliation not provided to SSRN ( email )

No Address Available

Yemei Yang

affiliation not provided to SSRN ( email )

No Address Available

Junyan Yue

affiliation not provided to SSRN ( email )

No Address Available

Jing Shi

affiliation not provided to SSRN ( email )

No Address Available

Jianxiang Lin

affiliation not provided to SSRN ( email )

No Address Available

Zhiwei Jiang

Beijing Key Tech Statistics Technology Co., Ltd. ( email )

Beijing Key Tech Statistics Technology Co., Ltd. ( email )

Ruoyu Hu

affiliation not provided to SSRN ( email )

No Address Available

Lei Shi

affiliation not provided to SSRN ( email )

No Address Available

Zhen Huang (Contact Author)

affiliation not provided to SSRN ( email )

No Address Available

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