Clinical Infectious Diseases (CID)
Volume 60 Issue 5 March 1, 2015
http://cid.oxfordjournals.org/content/current

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Review of Enterovirus 71 Vaccines
Pele Chong1,2, Chia-Chyi Liu1, Yen-Hung Chow1,2, Ai-Hsiang Chou1, and Michel Klein3
1Vaccine Research and Development Center, National Health Research Institutes, Zhunan Town
2Graduate Institute of Immunology, China Medical University, Taichung, Taiwan
3VaxiBio Inc, Toronto, Ontario, Canada
Stanley A. Plotkin, Section Editor
Abstract
Enterovirus 71 (EV71) and coxsackieviruses are the major causative agents of hand, foot, and mouth disease (HFMD) outbreaks worldwide and have a significant socioeconomic impact, particularly in Asia. Formalin-inactivated (FI) EV71 vaccines evaluated in human clinical trials in China, Taiwan, and Singapore were found to be safe and to elicit strong neutralizing antibody responses against EV71 currently circulating in Asia. The results from 3 different phase 3 clinical trials performed in young children (6–60 months) indicate that the efficacy of FI-EV71 vaccines is >90% against EV71-related HFMDs and >80% against EV71-associated serious diseases, but the vaccines did not protect against coxsackievirus A16 infections. Here we discuss the critical factors affecting EV71 vaccine product registration, including clinical epidemiology, antigenic shift issues in cross-protection and vaccine strain selection, standardized animal models for potency testing, and cost-effective manufacturing processes for potential incorporation of FI-EV71 vaccine into Expanded Programme on Immunization vaccines.

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Maternal Influenza Immunization and Birth Outcomes of Stillbirth and Spontaneous Abortion: A Systematic Review and Meta-analysis
Kristin N. Bratton1,2, Melissa T. Wardle1,2, Walter A. Orenstein1,2,3,4, and Saad B. Omer1,2,5
Author Affiliations
1Department of Epidemiology
2Hubert Department of Global Health, Rollins School of Public Health, Emory University
3Department of Medicine, Division of Infectious Diseases
4Influenza Pathogenesis and Immunology Research Center
5Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia
Abstract
Despite strong evidence that maternal influenza vaccination during pregnancy is safe, uptake of influenza vaccination during pregnancy remains low. We identified studies that assessed outcomes of stillbirth or spontaneous abortion after administration of influenza vaccine during pregnancy. We conducted a literature search in November 2013 that yielded 447 total citations. After removal of duplicates and studies deemed not relevant based on the title and abstract, 36 records underwent a full text review and 7 studies were included in the final review. Where possible, adjusted results were included in the meta-analysis. Women in the influenza vaccine group had a lower likelihood of stillbirth (relative risk [RR], 0.73; 95% confidence interval [CI], .55–.96); this association was similar when restricted to the H1N1pdm09 vaccine (RR, 0.69; 95% CI, .53–.90). The pooled estimate for spontaneous abortion was not significant (RR, 0.91; 95% CI, .68–1.22). These analyses add to the evidence base for the safety of influenza vaccination in pregnancy.