Japanese EncephalitisPhase 3NCT00595270

Long Term Persistence and Effect of a Booster Dose 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 the long term persistence the Japanese encephalitis vaccine IC51 and the need of a booster dose 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: 349 participants
Where: No sites listed yet
Study dates: Oct 2005to Apr 2009
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
Subjects correctly included in and having completed study IC51-304 according to the protocol.

Who cannot join

Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period
Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
Pregnancy, lactation or unreliable contraception in female subjects

About this study

The study investigates the long term persistence the Japanese encephalitis vaccine IC51 and the need of a booster dose

Read the detailed description

This is an open label, non-randomized multi-center phase 3 follow-up study. All volunteers having completed trial IC51-304 (NCT00595790) will be enrolled into this trial at 2 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 NCT00595270
Study group	Role	What they receive
IC51	Other	In study IC51-305, subjects who had received IC51 in study IC51-304 were tested for seroconversion 6 months after the first vaccination. Subjects who had protective titers were again tested for persistence of immunity at 12 months after the first immunization,whereas subjects who had titers below the seroconversion threshold by Month 6 received a booster dose of 1x6 mcg IC51 at Month 11. Their immune response was also assessed at Month 12. Thereafter, subjects who had no protective titer by Month 12 received a booster dose of 1x6 mcg IC51 at Month 23, regardless of prior treatment; and neutralizing antibody titers were reassessed at Month 24. Subjects who had protective titers at month 12 did not receive a booster at Month 23, and their neutralizing antibody titer was also assessed at Month 24. Receives: Biological: IC51

What is being measured

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

Long Term Immunogenicity of IC51 Vaccine 24 Months After the Primary Vaccination
Seroprotection rate (SPR) (anti-JEV neutralizing antibody titer ≥ 1:10) 24 months (M24) after the primary vaccination - imputed; Persistence of immunogenicity (SPR) at M24 defined as:
- pos. (positive) (persistent): Subjects
- with a non-missing, pos. seroconversion at D56 (Study IC51-304) and
- without booster at M11 or M23 and
- with non-missing, seroprotection (SP) pos. PRNT50 at M6 or M12 and
- with non-missing, SP pos. PRNT50 at M24
- neg. (negative) (non-persistent): Subjects with
- missing or neg. seroconversion at D56 (Study IC51-304) or
- booster at M11 or at M23, or
- non-missing, SP neg. PRNT50 at M6 or M12 or
- missing PRNT50 at both M6 and M12 or
- missing or SP neg. PRNT50 (serum dilution giving 50% reduction in plaques in a Plaque Reduction Neutralization Test) at M24
Measured: - 24 months

Secondary outcomes (6)

SPR 24 Months After the Primary Vaccination (Observed)
Persistence of immunogenicity (SPR) at M24 (observed) defined as :
- positive (persistent): Subjects
- with a non-missing, positive seroconversion at D56 (Study IC51-304), and
- who did not receive a booster dose at Visit 2 (M11) or Visit 4 (M23), and
- with a non-missing, SP positive PRNT50 result at Visit 1 (M6) or Visit 3 (M12), and
- with a non-missing, SP positive PRNT50 result at Visit 5 (M24)
- negative (non-persistent): Subjects
- with missing or negative seroconversion at D56 (Study IC51-304), or
- who did receive a booster dose at Visit 2 (M11) or at Visit 4 (M23), or
- with a non-missing, SP negative PRNT50 result at Visit 1 (M6) or Visit 3 (M12), or
- with a missing PRNT50 result at both Visit 1 (M6) and Visit 3 (M12), or
- with a non-missing, SP negative PRNT50 result at Visit 5 (M24)
Measured: 24 months
Persistent and Actual SPR 6, 12 and 24 Months After Primary Vaccination
Measured: - 24 months
Persistent and Actual GMT 6, 12 and 24 Months After Primary Vaccination
Measured: 24 months
SCR 1 Month After the Booster Doses
Measured: 1 month
GMT 1month After Booster Doses
Measured: 1 month
Safety Profile of IC51
Measured: study duration

Timeline

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

Oct 2005Apr 2009

First posted16 Jan 2008 (estimated)
Study startOct 2005
Primary completionSep 2007
Study completionApr 2009

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 349 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00595270
Sponsor's protocol ID: IC51-305
Status last verified: Feb 2014
First submitted: 4 Jan 2008
Last updated: 7 Mar 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 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51
ClinicalTrials.gov ID: NCT00595270
Acronym / sponsor ID: IC51-305
Conditions: Japanese Encephalitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 349 participants (actual)
Lead sponsor: Valneva Austria GmbHIndustry (pharma, biotech, devices)
Study start: Oct 2005
Primary completion: Sep 2007 (actual)
Study completion: Apr 2009 (actual)
First posted: 16 Jan 2008 (estimated)
Results: Posted 7 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 the long term persistence the Japanese encephalitis vaccine IC51 and the need of a booster dose

Detailed description

This is an open label, non-randomized multi-center phase 3 follow-up study. All volunteers having completed trial IC51-304 (NCT00595790) will be enrolled into this trial at 2 sites

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
IC51	Other	Biological: IC51In study IC51-305, subjects who had received IC51 in study IC51-304 were tested for seroconversion 6 months after the first vaccination. Subjects who had protective titers were again tested for persistence of immunity at 12 months after the first immunization,whereas subjects who had titers below the seroconversion threshold by Month 6 received a booster dose of 1x6 mcg IC51 at Month 11. Their immune response was also assessed at Month 12. Thereafter, subjects who had no protective titer by Month 12 received a booster dose of 1x6 mcg IC51 at Month 23, regardless of prior treatment; and neutralizing antibody titers were reassessed at Month 24. Subjects who had protective titers at month 12 did not receive a booster at Month 23, and their neutralizing antibody titer was also assessed at Month 24.

Who may qualify

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

Key inclusion criteria (3 listed)

At least 18 years of age
Written informed consent obtained prior to study entry
Subjects correctly included in and having completed study IC51-304 according to the protocol.

Key exclusion criteria (3 listed)

Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period
Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
Pregnancy, lactation or unreliable contraception in female subjects

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

Primary outcome

Long Term Immunogenicity of IC51 Vaccine 24 Months After the Primary Vaccination
Time frame: - 24 months
Seroprotection rate (SPR) (anti-JEV neutralizing antibody titer ≥ 1:10) 24 months (M24) after the primary vaccination - imputed; Persistence of immunogenicity (SPR) at M24 defined as: * pos. (positive) (persistent): Subjects * with a non-missing, pos. seroconversion at D56 (Study IC51-304) and * without booster at M11 or M23 and * with non-missing, seroprotection (SP) pos. PRNT50 at M6 or M12 and * with non-missing, SP pos. PRNT50 at M24 * neg. (negative) (non-persistent): Subjects with * missing or neg. seroconversion at D56 (Study IC51-304) or * booster at M11 or at M23, or * non-missing, SP neg. PRNT50 at M6 or M12 or * missing PRNT50 at both M6 and M12 or * missing or SP neg. PRNT50 (serum dilution giving 50% reduction in plaques in a Plaque Reduction Neutralization Test) at M24

6 secondary outcomes

SPR 24 Months After the Primary Vaccination (Observed)
Time frame: 24 months
Persistent and Actual SPR 6, 12 and 24 Months After Primary Vaccination
Time frame: - 24 months
Persistent and Actual GMT 6, 12 and 24 Months After Primary Vaccination
Time frame: 24 months
SCR 1 Month After the Booster Doses
Time frame: 1 month
GMT 1month After Booster Doses
Time frame: 1 month
Safety Profile of IC51
Time frame: study duration

Results and safety

Results posted to the registry on 7 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 µg	116	110
IC51 1 x 12 µg	117	107
IC51 1 x 6 µg	116	108

Primary outcome: Long Term Immunogenicity of IC51 Vaccine 24 Months After the Primary Vaccination

Time frame: - 24 months. Number (95% Confidence Interval). Unit: percentage of participants

Measure	IC51 2 x 6 µg n = 116	IC51 1 x 12 µg n = 117	IC51 1 x 6 µg n = 116
Value	56 (39.4 to 57.3)	7 (3.0 to 11.9)	5 (1.8 to 9.6)

Population analysed: ITT (Intent-To-Treat) Population: included all subjects rolled over from study IC51-304; analyzed according to treatment to which they were randomized in IC51-304

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IC51 2 x 6 µg	4 of 116 (3.4%)	61 of 116 (52.6%)	Not reported
IC51 1 x 12 µg	4 of 117 (3.4%)	69 of 117 (59%)	Not reported
IC51 1 x 6 µg	3 of 116 (2.6%)	64 of 116 (55.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 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 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 3 inclusion and 3 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 7 Mar 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 7 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?

Long Term Immunogenicity of IC51 Vaccine 24 Months After the Primary Vaccination (time frame: - 24 months). 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 NCT00595270.

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 7 Mar 2014.