Japanese EncephalitisPhase 3NCT00595790

Rapid Immunization Study of the Japanese Encephalitis Vaccine IC51

A Phase 3 study testing IC51 in people with Japanese Encephalitis, run by Valneva Austria GmbH.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The study investigates a rapid immunization regime of the Japanese Encephalitis vaccine IC51 (JE-PIV) in healthy subjects aged > or = 18 years Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Japanese Encephalitis
What is being tested?: IC51
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 374 participants
Where: No sites listed yet
Study dates: Sep 2005to Nov 2007
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

At least 18 years of age
Written informed consent obtained prior to study entry

Who cannot join

History of clinical manifestation of any flavivirus infection
History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever (an anti-JEV neutralizing antibody titer >= 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis)
Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
A family history of congenital or hereditary immunodeficiency
History of autoimmune disease

Show all 9Show fewer

Any acute infections within 4 weeks prior to enrollment
Infection with HIV, Hepatitis B or Hepatitis C
Pregnancy, lactation or unreliable contraception in female subjects

About this study

Official title: Phase 3 Study to Compare a Rapid Immunization Regime With the Standard Regime of IC51 as Vaccine for Japanese Encephalitis

The study investigates a rapid immunization regime of the Japanese Encephalitis vaccine IC51 (JE-PIV) in healthy subjects aged > or = 18 years

Read the detailed description

This is a multicenter, observer blinded, controlled, randomized phase 3 study. The study population consists of healthy male and female volunteers, aged at least 18 years.

Approximately 375 volunteers will be enrolled at approximately 2 to 3 sites.

Conditions: Japanese Encephalitis
Being tested: IC51
Medical subject headings: Encephalitis, Japanese

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IC51Biological
Also called Japanese Encephalitis purified inactivated vaccine

Study groups in NCT00595790
Study group	Role	What they receive
IC51 2 x 6 mcg	Active comparator	2 x 6 mcg (microgram) Receives: Biological: IC51
IC51 1 x 12 mcg	Active comparator	1 x 12 mcg (microgram) Receives: Biological: IC51
IC51 1 x 6 mcg	Active comparator	1 x 6 mcg (microgram) Receives: Biological: IC51

What is being measured

The primary outcome is the main question the study is designed to answer.

SCR (Seroconversion Rate) at Day 56
Seroconversion rate: percentage of subjects with >= 1:10 anti-JEV neutralizing antibody titer
Measured: day 56

Secondary outcomes (3)

SCR at Day 10, 28 and 35
Measured: Day 10, 28 and 35
GMT at Day 10, 28, 35 and 56
Measured: Day 10, 28, 35 and 56
Safety
AEs, Local and systemic tolerability, Safety laboratory parameters
Measured: Study duration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2005Nov 2007

First posted16 Jan 2008 (estimated)
Study startSep 2005
Primary completionFeb 2006
Study completionNov 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Japanese EncephalitisStudies 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 374 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00595790
Sponsor's protocol ID: IC51-304
Status last verified: Apr 2014
First submitted: 4 Jan 2008
Last updated: 29 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 4
Immunogenicity, Safety, and Antibody Persistence of Different Immunization Strategies Against Japanese Encephalitis
Japanese Encephalitis Vaccine
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
Not yet recruitingObservational study
Diagnostics and Surveillance of Acute Meningo-encephalitis Among Children in Cambodia With a Focus on Japanese Encephalitis Virus
Japanese Encephalitis
Active, not recruitingPhase 4
Monitoring JE Antibody Levels in Healthy Populations and Immunization Strategy in Low-Prevalence Areas
Japanese Encephalitis

All Japanese Encephalitis trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 3 Study to Compare a Rapid Immunization Regime With the Standard Regime of IC51 as Vaccine for Japanese Encephalitis
ClinicalTrials.gov ID: NCT00595790
Acronym / sponsor ID: IC51-304
Conditions: Japanese Encephalitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 374 participants (actual)
Lead sponsor: Valneva Austria GmbHIndustry (pharma, biotech, devices)
Study start: Sep 2005
Primary completion: Feb 2006 (actual)
Study completion: Nov 2007 (actual)
First posted: 16 Jan 2008 (estimated)
Results: Posted 26 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study investigates a rapid immunization regime of the Japanese Encephalitis vaccine IC51 (JE-PIV) in healthy subjects aged > or = 18 years

Detailed description

This is a multicenter, observer blinded, controlled, randomized phase 3 study. The study population consists of healthy male and female volunteers, aged at least 18 years.

Approximately 375 volunteers will be enrolled at approximately 2 to 3 sites.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
IC51 2 x 6 mcg	Active comparator	Biological: IC512 x 6 mcg (microgram)
IC51 1 x 12 mcg	Active comparator	Biological: IC511 x 12 mcg (microgram)
IC51 1 x 6 mcg	Active comparator	Biological: IC511 x 6 mcg (microgram)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

At least 18 years of age
Written informed consent obtained prior to study entry

Key exclusion criteria (9 listed)

History of clinical manifestation of any flavivirus infection
History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever (an anti-JEV neutralizing antibody titer >= 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis)
Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
A family history of congenital or hereditary immunodeficiency

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
IC51Also: Japanese Encephalitis purified inactivated vaccine	Biological	IC51 1 x 12 mcg, IC51 1 x 6 mcg, IC51 2 x 6 mcg

Primary outcome

SCR (Seroconversion Rate) at Day 56
Time frame: day 56
Seroconversion rate: percentage of subjects with >= 1:10 anti-JEV neutralizing antibody titer

3 secondary outcomes

SCR at Day 10, 28 and 35
Time frame: Day 10, 28 and 35
GMT at Day 10, 28, 35 and 56
Time frame: Day 10, 28, 35 and 56
Safety
Time frame: Study duration

Results and safety

Results posted to the registry on 26 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IC51 2 x 6 mcg	125	123
IC51 1 x 12 mcg	124	123
IC51 1 x 6 mcg	125	122

Primary outcome: SCR (Seroconversion Rate) at Day 56

Time frame: day 56. Number (95% Confidence Interval). Unit: percentage of participants

Measure	IC51 1 x 12 mcg n = 115	IC51 2x6 mcg n = 115	IC51 1x6 mcg n = 119
Value	41.2 (32.2 to 50.3)	97.3 (94.4 to 100.0)	25.6 (17.7 to 33.6)

IC51 1 x 12 mcg vs IC51 2x6 mcg: p >0.99, Mantel Haenszel

Population analysed: The Participant Flow shows all study participants randomized. The Primary Outcome is based on the Per-Protocol-Population (all randomized subjects without major protocol deviation

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IC51 2 x 6 mcg	0 of 125 (0%)	78 of 125 (62.4%)	Not reported
IC51 1 x 12 mcg	1 of 125 (0.8%)	82 of 125 (65.6%)	Not reported
IC51 1 x 6 mcg	0 of 124 (0%)	78 of 124 (62.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Japanese Encephalitis

Active, not recruitingPhase 4
Immunogenicity, Safety, and Antibody Persistence of Different Immunization Strategies Against Japanese Encephalitis
Japanese Encephalitis Vaccine
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
Not yet recruitingObservational study
Diagnostics and Surveillance of Acute Meningo-encephalitis Among Children in Cambodia With a Focus on Japanese Encephalitis Virus
Japanese Encephalitis
Active, not recruitingPhase 4
Monitoring JE Antibody Levels in Healthy Populations and Immunization Strategy in Low-Prevalence Areas
Japanese Encephalitis

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.

Susanne Eder, Mag. study director

Valneva Austria GmbH

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IC51 in people with Japanese Encephalitis, run by Valneva Austria GmbH.

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 2 inclusion and 9 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 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

SCR (Seroconversion Rate) at Day 56 (time frame: day 56). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00595790.

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 29 Apr 2014.