Safety and Immunogenicity Study of an Inactivated Vaccine Against Hand, Foot and Mouth Disease Caused by Enterovirus 71

Inclusion Criteria:

• Male or female aged 21 to 45 years, inclusive, at time of screening
• In good health as determined by medical history and physical examination.
• Normal clinical safety laboratory examinations.
• Body mass index (BMI) in the range 19-28 kg/m2.
• Documented negative serology for HIV, Hepatitis C antibody, and Hepatitis B surface antigen.
• Females of child bearing potential must have a negative urine pregnancy test result during screening and a negative urine pregnancy test immediately prior to vaccination.
• Willing and able to give written informed consent to participate.
• Willing and able to communicate with the Investigator and understand the requirements of the study.
• Low levels of EV71 neutralizing antibody.

Exclusion Criteria:

• Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
• Clinically significant hematological (including bleeding disorders), renal, hepatic, pulmonary (including asthma), central nervous system (including epilepsy, seizures, convulsions, or chronic migraines), cardiovascular, or gastrointestinal disorders, according to Investigator's judgment.
• Ongoing rash or other dermatologic disease.
• Abnormal ECG as assessed by the Investigator.
• History of diabetes mellitus.
• Hypersensitivity to any vaccine.
• History of severe HFMD with CNS involvement.
• Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
• Planned receipt of any vaccine in the 4 weeks following each of the vaccinations in this study.
• History of thymic pathology, thymectomy, myasthenia or any immunodeficiency.
• History of recurring migraines or on prescription medication for treatment of recurring headaches or migraines.
• Positive urine test for drugs of abuse.
• Females who are pregnant or lactating