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

Inviragen

Status and phase

Completed

Phase 1

Conditions

Hand, Foot and Mouth Disease

Treatments

Biological: Placebo

Biological: INV21 High Dose

Biological: INV21 Low Dose

Study type

Interventional

Funder types

Industry

Identifiers

NCT01376479

INV-EVR-101

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and immune response of an inactivated vaccine to prevent hand, foot and mouth disease (HFMD) caused by Enterovirus 71 (EV71).

Full description

Hand, foot and mouth disease (HFMD) caused by Enterovirus 71 (EV71) can be severely debilitating for some children with a risk of paralysis and death. The most susceptible age group is the 1 to 5 year olds, and the disease is spread via the oral-fecal route. Currently, there is no antiviral therapy nor there is a vaccine available to prevent HFMD. In this study, an inactivated vaccine (INV21) based on the EV71 antigen will be evaluated in terms of safety and immune response that is generated after two doses of the vaccine are given to healthy adults. Safety assessments include the frequency and severity of systemic adverse events as well as local reactions. Immune response will be assessed by measurement of EV71 neutralizing antibody levels at specified time points throughout the study.

Enrollment

36 patients

Sex

All

Ages

21 to 45 years old

Volunteers

Accepts Healthy Volunteers

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