- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01376479
Safety and Immunogenicity Study of an Inactivated Vaccine Against Hand, Foot and Mouth Disease Caused by Enterovirus 71
May 5, 2015 updated by: Inviragen Inc.
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
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Singapore, Singapore, 119074
- Investigational Medicine Unit, National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: INV21 Low Dose
|
Phosphate Buffered Saline (PBS)
Inactivated EV71 vaccine containing whole viral particles of EV71 formulated with aluminum hydroxide.
Other Names:
|
Experimental: INV21 High Dose
|
Phosphate Buffered Saline (PBS)
Inactivated EV71 vaccine consisting of whole viral particles of EV71 formulated with aluminum hydroxide.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
56 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Paul A Tambyah, MBBS, Department of Medicine, National University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
June 16, 2011
First Submitted That Met QC Criteria
June 17, 2011
First Posted (Estimate)
June 20, 2011
Study Record Updates
Last Update Posted (Estimate)
May 6, 2015
Last Update Submitted That Met QC Criteria
May 5, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- INV-EVR-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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