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

This study has been completed.
Information provided by (Responsible Party):
Takeda ( Inviragen Inc. ) Identifier:
First received: June 16, 2011
Last updated: May 5, 2015
Last verified: May 2015
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).

Condition Intervention Phase
Hand, Foot and Mouth Disease
Biological: INV21 Low Dose
Biological: INV21 High Dose
Biological: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

Further study details as provided by Takeda:

Primary Outcome Measures:
  • Frequency of systemic adverse events and local reactions in healthy adults following two doses of INV21 given 28 days apart [ Time Frame: 56 days ]
    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.

Secondary Outcome Measures:
  • Immunogenicity of INV21 vaccine in healthy adults following two doses given 28 days apart [ Time Frame: 8 months ]
    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.

Enrollment: 36
Study Start Date: August 2011
Study Completion Date: April 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INV21 Low Dose Biological: INV21 Low Dose
Inactivated EV71 vaccine containing whole viral particles of EV71 formulated with aluminum hydroxide.
Other Name: INV21
Biological: Placebo
Phosphate Buffered Saline (PBS)
Experimental: INV21 High Dose Biological: INV21 High Dose
Inactivated EV71 vaccine consisting of whole viral particles of EV71 formulated with aluminum hydroxide.
Other Name: INV21
Biological: Placebo
Phosphate Buffered Saline (PBS)

Detailed 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.

Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01376479

Investigational Medicine Unit, National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
Inviragen Inc.
Principal Investigator: Paul A Tambyah, MBBS Department of Medicine, National University Hospital
  More Information

Responsible Party: Inviragen Inc. Identifier: NCT01376479     History of Changes
Other Study ID Numbers: INV-EVR-101
Study First Received: June 16, 2011
Last Updated: May 5, 2015

Keywords provided by Takeda:

Additional relevant MeSH terms:
Enterovirus Infections
Mouth Diseases
Hand, Foot and Mouth Disease
Foot-and-Mouth Disease
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Stomatognathic Diseases
Coxsackievirus Infections
Aluminum Hydroxide
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents processed this record on May 23, 2017