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

Hand, Foot and Mouth Disease Clinical Trial

Official title:

Phase I, Double Blind, Randomized, Placebo-controlled, Dose Escalation Study to Assess the Safety and Immunogenicity of a Prophylactic Vaccine Against Enterovirus Infection in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01376479
• Other study ID #: INV-EVR-101
• Status: Completed
• Phase: Phase 1
• First received: June 16, 2011
• Last updated: May 5, 2015
• Start date: August 2011
• Est. completion date: April 2012

Study information

• Verified date: May 2015
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSingapore: Health Sciences AuthoritySingapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Enterovirus Infections
• Hand, Foot and Mouth Disease
• Mouth Diseases

Intervention

Biological:
• INV21 Low Dose
Inactivated EV71 vaccine containing whole viral particles of EV71 formulated with aluminum hydroxide.
• INV21 High Dose
Inactivated EV71 vaccine consisting of whole viral particles of EV71 formulated with aluminum hydroxide.
• Placebo
Phosphate Buffered Saline (PBS)

Locations

Country	Name	City	State
Singapore	Investigational Medicine Unit, National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Inviragen Inc.

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of systemic adverse events and local reactions in healthy adults following two doses of INV21 given 28 days apart	Frequency and severity of systemic adverse events up to 56 days post first dose. Frequency and severity of local reactions up to 14 days post each dose.	56 days	Yes
Secondary	Immunogenicity of INV21 vaccine in healthy adults following two doses given 28 days apart	Geometric mean titers based on neutralizing antibody titers. Measurement of fold-increase over baseline of neutralizing titers against EV71. Durability of immune response at 2 months and 6 months after the last dose.	8 months	No