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"enterovirus A71 and neutralization"
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Neutralizing Antibodies against Enteroviruses in Patients with Hand, Foot and Mouth Disease
Hand, foot and mouth disease (HFMD) is an emerging infection with pandemic potential. Knowledge of neutralizing antibody responses among its pathogens is essential to inform vaccine development and epidemiologic research. We used 120 paired-plasma samples collected at enrollment and >7 days after the onset of illness from HFMD patients infected with enterovirus A71 (EV-A71), coxsackievirus A (CVA) 6, CVA10, and CVA16 to study cross neutralization. For homotypic viruses, seropositivity increased from <60% at enrollment to 97%-100% at follow-up, corresponding to seroconversion rates of 57%-93%. Seroconversion for heterotypic viruses was recorded in only 3%-23% of patients. All plasma samples from patients infected with EV-A71 subgenogroup B5 could neutralize the emerging EV-A71 subgenogroup C4. Collectively, our results support previous reports about the potential benefit of EV-A71 vaccine but highlight the necessity of multivalent vaccines to control HFMD.
Journal Article
Enhancing enterovirus A71 vaccine production yield by microcarrier profusion bioreactor culture
Hand, foot and mouth diseases (HFMD) are mainly caused by Enterovirus A71 (EV-A71) infections. Clinical trials in Asia conducted with formalin-inactivated EV-A71 vaccine candidates produced from serum-free Vero cell culture using either roller bottle or cell factory technology, are found to be safe and highly efficacious. To increase vaccine yields and reduce the production costs, the bioprocess improvement for EV-A71 vaccine manufacturing is currently being investigated. The parameters that could affect and enhance the production yields of EV-A71 virus growth in the microcarrier bioreactor were investigated. The medium replacement culture strategy included a multi-harvested semi-batch process and perfusion technology and was found to increase the production yields more than 7–14 folds. Based on the western blot and cryo-EM analyses of the EV-A71 virus particles produced from either the multi-harvested semi-batch (MHSBC) or perfusion cultures were found to be similar to those virus particles obtained from the single batch culture. Mouse immunogenicity studies indicate that the EV-A71 vaccine candidates produced from the perfusion culture have similar potency to those obtained from single batch bioprocess. The physical structures of the EV-A71 particles revealed by the cryo-EM analysis were found to be spherical capsid particles. These results provide feasible technical bioprocesses for increasing virus yields and the scale up of EV-A71 vaccine manufacturing using the bioreactor cell culture methods.
Journal Article
Immunogenicity, safety, cross-reaction, and immune persistence of an inactivated enterovirus A71 vaccine in children aged from two months to 11 years in Taiwan
•The first EV-A71 vaccine trial on two-month-old infants.•The EV-A71 vaccine elicited good immune response and cross reaction.•Three dosing regimens demonstrated a good immune persistence on young infants.
To fight against enterovirus A71 (EV-A71)-associated diseases, vaccine development was initiated in Taiwan focusing on two-month-old infants.
We conducted a phase II, double-blind, randomised, placebo-controlled study on infants and children aged two months to 11 years. This study was conducted in 4 parts (2a, 2b, 2c, and 2d) with age de-escalation sequentially. Two doses were administered with a 28-day or 56-day interval. Participants aged two months to
Journal Article
Immunogenicity and safety of an inactivated enterovirus A71 vaccine in children 3–6 years and 2–35 months of age- an open-label, randomized phase IIb clinical trial
•An inactivated EV-A71 vaccine is safe and immunogenic in children 2 months to 6 years of age.•Adjuvanted 1.0 μg total viral protein elicited higher titers of neutralizing antibody than adjuvanted 0.5 μg total protein.•Elicited neutralizing antibody could last for up to a year.
Enterovirus A71 (EV-A71) infection can cause severe debilitating complications and even death in young children. The immunogenicity and safety of an inactivated whole EV-A71 virus vaccine were assessed in children 2 months to 6 years of age.
This was an open-label, multi-center and randomized phase IIb study, which divided into part A and B. In part A, children 36 months to 6 years of age were enrolled and randomized into 3 groups, receiving 0.5 μg total viral protein (TP) with adjuvant Al(OH)3, 1.0 μg TP with Al(OH)3 or 1.0 μg TP only. Two doses of vaccines were administered at a 28-day interval and blood was taken before immunization, at week 4, 8, 28 and 52 (optional) for virus neutralization assay. Safety profiles were also monitored. After safety profiles had shown no concerns, children 2 months to 35 months of age (part B) were subsequently enrolled following the same protocol.
A total of 135 children completed two doses of immunization, including 58 in part A and 77 in part B. Both adjuvanted 0.5 μg and 1.0 μg TP elicited significant raise of neutralizing antibody titers and seroconversion rate was up to 93.75–100.0% after 2 doses of immunization. Adjuvanted 1.0 μg TP induced higher titers of neutralizing antibodies than adjuvanted 0.5 μg TP. By contrast, non-adjuvanted 1.0 μg TP was not immunogenic. No major adverse events were reported.
This EV-A71 vaccine containing adjuvant is immunogenic and safe in children 2 months to 6 years of age.
Clinical Trials Registration.NCT03268083.
Journal Article