NCT01376479

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

May 6, 2015

Status Verified

May 1, 2015

Enrollment Period

3 months

First QC Date

June 16, 2011

Last Update Submit

May 5, 2015

Conditions

Hand, Foot and Mouth Disease

Keywords

HFMDEV71EnterovirusINV21Encephalitis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Immunogenicity of INV21 vaccine in healthy adults following two doses given 28 days apart

    8 months

Study Arms (2)

INV21 Low Dose

EXPERIMENTAL
Biological: INV21 Low DoseBiological: Placebo

INV21 High Dose

EXPERIMENTAL
Biological: INV21 High DoseBiological: Placebo

Interventions

INV21 Low DoseBIOLOGICAL

Inactivated EV71 vaccine containing whole viral particles of EV71 formulated with aluminum hydroxide.

Also known as: INV21
INV21 Low Dose
INV21 High DoseBIOLOGICAL

Inactivated EV71 vaccine consisting of whole viral particles of EV71 formulated with aluminum hydroxide.

Also known as: INV21
INV21 High Dose
PlaceboBIOLOGICAL

Phosphate Buffered Saline (PBS)

INV21 High DoseINV21 Low Dose

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational Medicine Unit, National University Hospital

Singapore, 119074, Singapore

Location

MeSH Terms

Conditions

Hand, Foot and Mouth DiseaseEnterovirus InfectionsEncephalitis

Condition Hierarchy (Ancestors)

Coxsackievirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory Diseases

Study Officials

  • Paul A Tambyah, MBBS

    Department of Medicine, National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2011

First Posted

June 20, 2011

Study Start

August 1, 2011

Primary Completion

November 1, 2011

Study Completion

April 1, 2012

Last Updated

May 6, 2015

Record last verified: 2015-05

Locations

SG(1)