Tolerability and immunogenicity of an inactivated enterovirus 71 vaccine in Chinese healthy adults and children

Abstract

In this open labeled phase 1 clinical trial with enterovirus 71 (EV71) vaccine (ClinicalTrials.gov number: NCT01267903) performed in Donghai County, Jiangsu Province, China, in January 2011. A total of 100 healthy participants, stratified by age (40 adults aged 16–22 y and 60 children aged 6–15 y), were enrolled from volunteers and sequentially received EV71 vaccines of 160U (only for children), 320U, or 640U on day 0 and 28, in a manner of dose escalation. All the participants were followed for 28 d after each shot. During the study period, 37 participants reported at least one injection-site or systemic adverse reaction. No case of grade 3 adverse reaction or serious adverse event (SAE) was observed. Also no dose-related increase in reaction rate was noticed. Pain at injection-site and fever were the most frequently reported local and systematic reaction, respectively. The studied EV71 vaccines demonstrated acceptable tolerability and no anti-nuclear antibody (ANA) seropositive was detected pre or post vaccinations in participants. Also, no clinically significant abnormal change for the liver or kidney function indexes was found. In the according-to-protocol cohort for immunogenicity, it was observed one dose of EV71 vaccine elicited good immune response in the participants, especially for the ones with sero-positive baseline. No obvious dose-response relationship for immunogenicity was found. This study was co-founded by Beijing Vigoo Biological Co., LTD and Chinese governmental grants (2008BAI69B01 and 2009ZX10004–806).

Keywords: :

• Enterovirus 71
• foot and mouth disease
• hand
• immunogenicity
• inactivated vaccine
• tolerability

Disclosure of Potential Conflicts of Interest

Xiu-Ling Li, Yun-Tao Zhang are employees of Beijing Vigoo Biological Co., LTD. The other authors declare that they have no conflicts of interest.

Financial Disclosure

This study was co-founded by Beijing Vigoo Biological Co., LTD and Chinese governmental grants (2008BAI69B01 and 2009ZX10004–806).

Role of the Funding Source

The study was co-sponsored by governmental grants (2008BAI69B01 and 2009ZX10004–806) and Beijing Vigoo Biological Co., LTD, which was involved in trial design, not involved in data collection, analysis, interpretation, and report writing. The corresponding authors were responsible for submitting the manuscript for publication and had full access to the data.

Ethics Committee Approval

Institutional review board approvals were obtained from the ethics committee of the Jiangsu Provincial Center for Disease Control and Prevention (JSCDC). This study was performed in accordance with the GCP and Helsinki Declaration of 1975.

Acknowledgments

This study was co-founded by Beijing Vigoo Biological Co., LTD and Chinese governmental grants (2008BAI69B01 and 2009ZX10004–806). We thank the following investigators, from Donghai county Center for Disease Control and Prevention, contributed to the trial: Y.Wang, H.-Y.Pang, B.Sun, T.-H.Wu, B.-Y.Xie, Q.-K.Wang, J.Zhang, S.-M.Hu, Z.-J.Ma, X.-Y.Qin, D.-J.Lu, H.-Z.Lu, Y.-L.Zhang, L.-H.Liu, J.-P.Tian, B.-Y.Yang, J.-F.Liu, B.-J.Yin, J.Cheng, K.-S.Zhang, Z.-S.Zhou, L.Chen,M.Lv, S.-R.Li, S.-Y.Li, L.Ge, H.-R.Liu, H.-X.Yan, S.-Q. Sun. We thank the following members from National Vaccine and Serum Institute for suggestion on clinical trial in this study: Dr. K. Zhao and Dr. W.-Y. Ze; The Shenzhengshi Ying He Yuan Medical Technology Development CO. LTD for monitoring the study.

Supplemental Materials

Supplemental Materials

Supplemental materials can be found at: www.landesbioscience.com/journals/vaccines/article/19521