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

Primary Purpose

Hand, Foot and Mouth Disease

Status

Completed

Phase

Phase 1

Locations

Singapore

Study Type

Interventional

Intervention

INV21 Low Dose

INV21 High Dose

Placebo

About this trial

This is an interventional prevention trial for Hand, Foot and Mouth Disease focused on measuring HFMD, EV71, Enterovirus, INV21, Encephalitis

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts 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

Sites / Locations

Investigational Medicine Unit, National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

INV21 Low Dose

INV21 High Dose

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01376479

First Posted

June 16, 2011

Last Updated

May 5, 2015

Sponsor

Inviragen Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01376479

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Inviragen Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hand, Foot and Mouth Disease

Keywords

HFMD, EV71, Enterovirus, INV21, Encephalitis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

INV21 Low Dose

Arm Type

Experimental

Arm Title

INV21 High Dose

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

INV21 Low Dose

Other Intervention Name(s)

INV21

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

INV21 High Dose

Other Intervention Name(s)

INV21

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Phosphate Buffered Saline (PBS)

Primary Outcome Measure Information:

Title

Frequency of systemic adverse events and local reactions in healthy adults following two doses of INV21 given 28 days apart

Description

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.

Time Frame

56 days

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

8 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul A Tambyah, MBBS

Organizational Affiliation

Department of Medicine, National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Investigational Medicine Unit, National University Hospital

City

Singapore

ZIP/Postal Code

119074

Country

Singapore

12. IPD Sharing Statement

Learn more about this trial

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

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