Japanese EncephalitisPhase 4NCT01567865
Lot-to-lot Consistency Trial of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine
A Phase 4 study testing Vaccine produced in existing facility and Vaccine produced in new facility in people with Japanese Encephalitis, run by PATH at 1 site in Bangladesh.
Trial summary
The proposed study is a four-arm double-blind randomized controlled single center trial to evaluate, by examining post-vaccination seroprotection titers, the lot-to-lot consistency of three lots of Japanese Encephalitis live attenuated SA 14-14-2 vaccine (LJEVac) manufactured in a new good manufacture practice (GMP)… Read more about this study
- Who is it for?
- Ages 10 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Japanese Encephalitis
- What is being tested?
- Vaccine produced in existing facility and Vaccine produced in new facility
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 818 participants
- Where
- 1 siteBangladesh
- Study dates
- May 2012to Dec 2012
- Phase
- Phase 4
- 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 10 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infant's parent(s) or legal guardian(s) willing to provide signed informed consent.
- Healthy infants aged 10 to 12 months at enrolment residing in Matlab Health and Demographic Surveillance System (HDSS) intervention area who have completed all doses of Expanded Programme on Immunization (EPI) immunizations at least 4 weeks prior to enrolment: Bacillus Calmette-Guerin vaccine (BCG), Diphtheria-pertussis-tetanus vaccine (DPT), Hepatitis B (HBV), Haemophilus influenzae type (Hib), oral polio vaccine (OPV) and measles
Who cannot join
- Acute medical illness with or without fever within the last 72 hours or an axillary temperature (≥ 37.5°C ) at the time of vaccination.
- Use of antibiotics or antipyretics within the last 72 hours prior to enrolment.
- Severely or moderately malnourished infants (<-3 Z score).
- History of prematurity (< 36 weeks of pregnancy).
- Underlying medical condition such as failure to thrive, inborn errors of metabolism, bronchopulmonary dysplasia, or any major congenital abnormalities requiring surgery or chronic treatment.
- History of serious chronic disease (e.g., cardiac, renal, neurologic, metabolic, rheumatologic, hematologic, or bleeding disorder).
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- Known or suspected impairment of immunologic function.
- History of documented or suspected encephalitis or meningitis.
- History of seizures, including history of febrile seizures, or any other neurologic disorder.
- History of JE infection.
- Prior receipt of a JE vaccine.
- Received measles vaccine within 4 weeks prior to, or scheduled to receive a vaccination during, the conduct of this trial.
- Prior or anticipated receipt of immune globulin or other blood products, or injected or oral corticosteroids or other immune modulator therapy within 6 weeks of administration of the study vaccine.
- Serious adverse reactions (e.g. urticaria, angioedema, shock, breathlessness following vaccination or any life threatening condition) with any previous EPI vaccine.
- Unable to attend the scheduled visits or comply with the study procedures.
- Enrolled in another clinical trial involving any therapy.
- Any condition that in the opinion of the investigator, would pose a health risk to the child, or interfere with the evaluation of the study objectives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Trial in Healthy Infants to Assess Lot-to-lot Consistency of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine and Non-inferiority With Respect to an Earlier Product.
The proposed study is a four-arm double-blind randomized controlled single center trial to evaluate, by examining post-vaccination seroprotection titers, the lot-to-lot consistency of three lots of Japanese Encephalitis live attenuated SA 14-14-2 vaccine (LJEVac) manufactured in a new good manufacture practice (GMP) facility, and to establish non-inferiority of the new vaccine in comparison to a single lot of the same vaccine manufactured in the existing facility. The study aimed to enroll a total of 1,000 Bangladeshi infants aged 10 to 12 months. In addition to providing immunogenicity data, this study provided local safety data of JE live attenuated SA 14-14-2 vaccine among Bangladeshi children. This is the first step to secure licensure for this life-saving vaccine in Bangladesh as well as provide data to support WHO prequalification of JE live attenuated SA 14-14-2 vaccine.
- Conditions
- Japanese Encephalitis
- Being tested
- Vaccine produced in existing facility, Vaccine produced in new facility
- Medical subject headings
- Encephalitis, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine produced in existing facilityBiological
Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
Vaccine produced in new facilityBiological
Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
| Study group | Role | What they receive |
|---|---|---|
| Reference Lot | Active comparator | Lot of Vaccine produced in existing facility Receives: Biological: Vaccine produced in existing facility |
| New Lot #1 | Experimental | First lot of vaccine produced in new facility Receives: Biological: Vaccine produced in new facility |
| New Lot #2 | Experimental | Second lot of vaccine produced in new facility Receives: Biological: Vaccine produced in new facility |
| New Lot #3 | Experimental | Third lot of vaccine produced in new facility Receives: Biological: Vaccine produced in new facility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number/Percentage of Subjects With Demonstrated Seroprotection
Seroprotection was defined as a serum antibody titer equal to or greater than 1:10, as measured by Plaque reduction neutralization test (PRNT). The end point for neutralization was the highest dilution of serum reducing the number of plaques by 50%, compared with a negative serum control.
In 2004, a group of experts under the leadership of the WHO recommended that seroprotection (SP) against JEV be defined as a neutralizing anti-JEV antibody serum titer ≥1:10 as determined by PRNT [Hombach et al. 2005]. Accordingly, a titer of ≥1:10 was adopted as an indicator of seroprotection in this study.
Measured: 28 days post-vaccination
Geometric Mean Titers (GMT)
Geometric Mean Titers of Neutralizing anti-JEV antibody
Measured: 28 days post-vaccination
Secondary outcomes (3)
Number/Percentage of Subjects With an Immediate Solicited Local or Systemic Reactogenicity Event (RE)
Subjects were monitored for the following adverse events and categorized as events almost certainly related to receipt of the vaccine:
Redness Swelling Tenderness Dyspnea Cyanosis Loose Stools Vomiting Convulsion Fever (37 degrees Celsius or greater, axillary) Hives (urticaria) Angioedema
Measured: Within 30 minutes of vaccination
Number/Percentage of Subjects With a Solicited Local or Systemic Reactogenicity Event Within 7 Days After Vaccination
Collected by a home visit to observe the subject and interview his/her parent or guardian occurrence and severity of solicited injection site reactogenicity events (REs) related to vaccination and solicited systemic REs or other AEs that might or might not be related to the prior receipt of vaccine
Measured: Within 7 days of vaccination
Number/Percentage of Subjects With Other Adverse Events (AE) During the Study
Adverse events other than solicited reactogenicities were obtained through review of medical history when subject returned to clinic. They were graded for severity and rated by the PI for possible relationship to vaccination throughout the 28 days study period.
Measured: Between 7 and 28 days of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2012
- Study completionDec 2012
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 818 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- K Zaman, MD, Principal investigator, ICCDR,B
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567865
- Sponsor's protocol ID
- JEV05 (VAC004)
- Status last verified
- Nov 2018
- First submitted
- 28 Mar 2012
- Last updated
- 5 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial in Healthy Infants to Assess Lot-to-lot Consistency of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine and Non-inferiority With Respect to an Earlier Product.
- ClinicalTrials.gov ID
- NCT01567865
- Acronym / sponsor ID
- JEV05 (VAC004)
- Conditions
- Japanese Encephalitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 818 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Mar 2012 (estimated)
- Results
- Posted 13 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is a four-arm double-blind randomized controlled single center trial to evaluate, by examining post-vaccination seroprotection titers, the lot-to-lot consistency of three lots of Japanese Encephalitis live attenuated SA 14-14-2 vaccine (LJEVac) manufactured in a new good manufacture practice (GMP) facility, and to establish non-inferiority of the new vaccine in comparison to a single lot of the same vaccine manufactured in the existing facility. The study aimed to enroll a total of 1,000 Bangladeshi infants aged 10 to 12 months. In addition to providing immunogenicity data, this study provided local safety data of JE live attenuated SA 14-14-2 vaccine among Bangladeshi children. This is the first step to secure licensure for this life-saving vaccine in Bangladesh as well as provide data to support WHO prequalification of JE live attenuated SA 14-14-2 vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Reference Lot | Active comparator | Biological: Vaccine produced in existing facilityLot of Vaccine produced in existing facility |
| New Lot #1 | Experimental | Biological: Vaccine produced in new facilityFirst lot of vaccine produced in new facility |
| New Lot #2 | Experimental | Biological: Vaccine produced in new facilitySecond lot of vaccine produced in new facility |
| New Lot #3 | Experimental | Biological: Vaccine produced in new facilityThird lot of vaccine produced in new facility |
Who may qualify
- Ages
- 10 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infant's parent(s) or legal guardian(s) willing to provide signed informed consent.
- Healthy infants aged 10 to 12 months at enrolment residing in Matlab Health and Demographic Surveillance System (HDSS) intervention area who have completed all doses of Expanded Programme on Immunization (EPI) immunizations at least 4 weeks prior to enrolment: Bacillus Calmette-Guerin vaccine (BCG), Diphtheria-pertussis-tetanus vaccine (DPT), Hepatitis B (HBV), Haemophilus influenzae type (Hib), oral polio vaccine (OPV) and measles
Key exclusion criteria (17 listed)
- Acute medical illness with or without fever within the last 72 hours or an axillary temperature (≥ 37.5°C ) at the time of vaccination.
- Use of antibiotics or antipyretics within the last 72 hours prior to enrolment.
- Severely or moderately malnourished infants (<-3 Z score).
- History of prematurity (< 36 weeks of pregnancy).
- Underlying medical condition such as failure to thrive, inborn errors of metabolism, bronchopulmonary dysplasia, or any major congenital abnormalities requiring surgery or chronic treatment.
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 |
|---|---|---|
| Vaccine produced in existing facilityLive attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China | Biological | Reference Lot |
| Vaccine produced in new facilityLive attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China | Biological | New Lot #1, New Lot #2, New Lot #3 |
Primary outcome
Number/Percentage of Subjects With Demonstrated Seroprotection
Time frame: 28 days post-vaccination
Seroprotection was defined as a serum antibody titer equal to or greater than 1:10, as measured by Plaque reduction neutralization test (PRNT). The end point for neutralization was the highest dilution of serum reducing the number of plaques by 50%, compared with a negative serum control. In 2004, a group of experts under the leadership of the WHO recommended that seroprotection (SP) against JEV be defined as a neutralizing anti-JEV antibody serum titer ≥1:10 as determined by PRNT [Hombach et al. 2005]. Accordingly, a titer of ≥1:10 was adopted as an indicator of seroprotection in this study.
Geometric Mean Titers (GMT)
Time frame: 28 days post-vaccination
Geometric Mean Titers of Neutralizing anti-JEV antibody
3 secondary outcomes
Number/Percentage of Subjects With an Immediate Solicited Local or Systemic Reactogenicity Event (RE)
Time frame: Within 30 minutes of vaccination
Number/Percentage of Subjects With a Solicited Local or Systemic Reactogenicity Event Within 7 Days After Vaccination
Time frame: Within 7 days of vaccination
Number/Percentage of Subjects With Other Adverse Events (AE) During the Study
Time frame: Between 7 and 28 days of vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
K Zaman, MD principal investigator
ICCDR,B
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vaccine produced in existing facility and Vaccine produced in new facility in people with Japanese Encephalitis, run by PATH at 1 site in Bangladesh.
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 17 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 5 Dec 2018. 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 Bangladesh. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 13 Nov 2018). 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?
Number/Percentage of Subjects With Demonstrated Seroprotection (time frame: 28 days post-vaccination). The study lists 2 primary outcomes in all. 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 5 Dec 2018.