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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Takeda ( Inviragen Inc. )

ClinicalTrials.gov Identifier:

NCT01376479

First received: June 16, 2011

Last updated: May 5, 2015

Last verified: May 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

June 16, 2011

Last Updated Date

May 5, 2015

Start Date ^ICMJE

August 2011

Primary Completion Date

November 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01376479 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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).

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Hand, Foot and Mouth Disease

Intervention ^ICMJE

Biological: INV21 Low Dose
Inactivated EV71 vaccine containing whole viral particles of EV71 formulated with aluminum hydroxide.

Other Name: INV21
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)

Study Arms

Experimental: INV21 Low Dose
Interventions:
- Biological: INV21 Low Dose
- Biological: Placebo
Experimental: INV21 High Dose
Interventions:
- Biological: INV21 High Dose
- Biological: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2012

Primary Completion Date

November 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

21 Years to 45 Years (Adult)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Singapore

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01376479

Other Study ID Numbers ^ICMJE

INV-EVR-101

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Takeda ( Inviragen Inc. )

Study Sponsor ^ICMJE

Inviragen Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Paul A Tambyah, MBBS

Department of Medicine, National University Hospital

PRS Account

Takeda

Verification Date

May 2015

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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