Hand, Foot and Mouth DiseasePhase 1NCT01376479
Safety and Immunogenicity Study of an Inactivated Vaccine Against Hand, Foot and Mouth Disease Caused by Enterovirus 71
A Phase 1 study testing INV21 Low Dose and INV21 High Dose in people with Hand, Foot and Mouth Disease, run by Inviragen Inc. at 1 site in Singapore.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand, Foot and Mouth Disease
- What is being tested?
- INV21 Low Dose and INV21 High Dose
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2011to Apr 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Investigational Medicine Unit, National University Hospital
Singapore, 119074
About this study
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
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).
Read the 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.
- Conditions
- Hand, Foot and Mouth Disease
- Being tested
- INV21 Low Dose, INV21 High Dose, Placebo
- Keywords
- HFMD, EV71, Enterovirus, INV21, Encephalitis
- Medical subject headings
- Hand, Foot and Mouth Disease, Enterovirus Infections, Encephalitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INV21 Low DoseBiological
Also called INV21
Inactivated EV71 vaccine containing whole viral particles of EV71 formulated with aluminum hydroxide.
INV21 High DoseBiological
Also called INV21
Inactivated EV71 vaccine consisting of whole viral particles of EV71 formulated with aluminum hydroxide.
PlaceboBiological
Phosphate Buffered Saline (PBS)
| Study group | Role | What they receive |
|---|---|---|
| INV21 Low Dose | Experimental | Not described Receives: Biological: INV21 Low Dose; Biological: Placebo |
| INV21 High Dose | Experimental | Not described Receives: Biological: INV21 High Dose; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 56 days
Secondary outcomes (1)
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.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand, Foot and Mouth DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inviragen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul A Tambyah, MBBS, Principal investigator, Department of Medicine, National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376479
- Sponsor's protocol ID
- INV-EVR-101
- Status last verified
- May 2015
- First submitted
- 16 Jun 2011
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01376479
- Acronym / sponsor ID
- INV-EVR-101
- Conditions
- Hand, Foot and Mouth Disease
- Keywords
- HFMD, EV71, Enterovirus, INV21, Encephalitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Inviragen Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 20 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INV21 Low Dose | Experimental | Biological: INV21 Low Dose, Biological: Placebo |
| INV21 High Dose | Experimental | Biological: INV21 High Dose, Biological: Placebo |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INV21 Low DoseAlso: INV21Inactivated EV71 vaccine containing whole viral particles of EV71 formulated with aluminum hydroxide. | Biological | INV21 Low Dose |
| INV21 High DoseAlso: INV21Inactivated EV71 vaccine consisting of whole viral particles of EV71 formulated with aluminum hydroxide. | Biological | INV21 High Dose |
| PlaceboPhosphate Buffered Saline (PBS) | Biological | INV21 High Dose, INV21 Low Dose |
Primary outcome
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.
1 secondary outcome
Immunogenicity of INV21 vaccine in healthy adults following two doses given 28 days apart
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
Related trials for Hand, Foot and Mouth Disease
Not yet recruiting
CHIPCAT and HFMD-PREP for HFMD Prevention in Childcare Centres in Kota Kinabalu
Hand, Foot and Mouth Disease, Infection Control
Not yet recruiting
Bridging Clinical Trial of EV71 Vaccine in Vietnamese Children
Hand, Foot, and Mouth Disease (HFMD), Enterovirus 71 Infection
Not yet recruitingPhase 3
Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell).
Hand, Foot, and Mouth Disease(HFMD), Herpangina
Not yet recruitingPhase 1
Phase I Clinical Trial of Enterovirus Type71 - Coxsackievirus Type A16 Bivalent Vaccine
Hand, Foot and Mouth Disease (HFMD), HFMD
Enrolling by invitationObservational study
Study on the Persistence of Immunity Following EV71 Vaccination
Hand, Foot, and Mouth Disease, Hand, Foot, and Mouth Disease (HFMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul A Tambyah, MBBS principal investigator
Department of Medicine, National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INV21 Low Dose and INV21 High Dose in people with Hand, Foot and Mouth Disease, run by Inviragen Inc. at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of systemic adverse events and local reactions in healthy adults following two doses of INV21 given 28 days apart (time frame: 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2015.