Healthy InfantsPhase 4NCT01635816
Immunogenicity of SA 14-14-2 JE Vaccine
A Phase 4 study testing JE Vaccine existing facility, JE vaccine new plant lot 1 and JE vaccine new plant lot 2 in people with Healthy Infants, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
The proposed Japanese Encephalitis (JE)Vaccine 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 JE live attenuated SA 14-14-2 vaccine manufactured in a new GMP facility, and to… Read more about this study
- Who is it for?
- Ages 10 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy Infants
- What is being tested?
- JE Vaccine existing facility, JE vaccine new plant lot 1 and JE vaccine new plant lot 2
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteBangladesh
- Study dates
- May 2012to Dec 2012
- Phase
- Phase 4
- 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 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 enrollment residing in Matlab HDSS intervention area who have completed all doses of EPI immunizations (BCG, DPT, HBV, Hib, OPV and measles) at least 4 weeks prior to enrollment.
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 enrollment.
- 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).
Show all 17Show fewer
- 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 Manufactured in a New Good Manufacturing Practices Facility and Non-inferiority With Respect to an Earlier Product.
The proposed Japanese Encephalitis (JE)Vaccine 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 JE live attenuated SA 14-14-2 vaccine manufactured in a new 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 will enroll a total of 1,000 Bangladeshi infants aged 10 to 12 months. In addition to providing immunogenicity data, JEV05 will provide local safety data of JE live attenuated SA 14-14-2 vaccine among Bangladeshi children. This will be 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.
Read the detailed description
Vaccination is the most effective intervention to prevent JE and its associated morbidity and mortality (http://www.who.int.nuvi/Je/en). JE live attenuated SA 14-14-2 vaccine has been used in Asia for more than two decades in over 400 million children. Chengdu Institute of Biological Products (CDIBP), a Chinese manufacturer, has been producing JE live attenuated SA 14-14-2 vaccine since 1988. It has been demonstrated to be both safe and immunogenic in several observational and case-control studies providing protection for at least 5 years following a single dose. JE live attenuated SA 14-14-2 vaccine is licensed for use in China, India, Nepal, South Korea, Sri Lanka, and Thailand. Countries that have introduced JE vaccine into their national immunization programs have experienced dramatic reductions in JE incidence, leading WHO to declare vaccination the preferred JE control strategy.4
In order for JE live attenuated SA 14-14-2 vaccine to be available for purchase through UNICEF and GAVI for broader international use, including in Bangladesh, JE live attenuated SA 14-14-2 vaccine needs to undergo WHO prequalification. With technical support from PATH, CDIBP has established a new GMP facility, Building 208 JE production unit, maintaining WHO standards. A GMP Certificate for the new facility was issued on 11/16/2011. This certificate provides market authorization to distribute the new vaccine in China. To achieve WHO prequalification, JE live attenuated SA 14-14-2 vaccine produced in this new GMP facility needs to be shown to be similarly safe and immunogenic to JE live attenuated SA 14-14-2 vaccine produced in the existing facility, the JE viral vaccine production plant, and needs to demonstrate lot-to-lot consistency.
The proposed JEV05 study is a four-arm double-blind randomized controlled single center trial testing the immunogenicity of four lots of JE live attenuated SA 14-14-2 vaccine - three lots manufactured in the new GMP facility and one lot from the existing facility - in a total of 1000 Bangladeshi infants aged 10 to 12 months. The study will be conducted in the Matlab Health and Demographic Surveillance System (HDSS) intervention area, a rural site where many vaccine trials have been conducted.
A 5 ml blood sample will be collected from each child before vaccination and at 28 days post-vaccination. The sera will be tested using a plaque reduction neutralization test (PRNT) with JE neutralizing antibody titers > 1:10 considered seroprotective. The JEV05 trial will provide immunogenicity data on the three vaccine lots produced in the new GMP facility compared to a vaccine lot produced in the prior existing plant. It will also provide local immunogenicity and safety data of JE live attenuated SA 14-14-2 vaccine among Bangladeshi children. This will be 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
- Healthy Infants
- Being tested
- JE Vaccine existing facility, JE vaccine new plant lot 1, JE vaccine new plant lot 2, JE vaccine new plant lot 3
- Keywords
- Immunogenicity, SA 14-14-2 JE vaccine, Bangladesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JE Vaccine existing facilityBiological
Will receive JE live attenuated SA 14-14-2 vaccine manufactured in the existing facility (250 infants).
JE vaccine new plant lot 1Biological
Will receive Lot 1 JE live attenuated SA 14-14-2 vaccine manufactured in the new GMP facility (250 infants).
JE vaccine new plant lot 2Biological
Will receive Lot 2 JE live attenuated SA 14-14-2 vaccine manufactured in the new GMP facility (250 infants).
JE vaccine new plant lot 3Biological
Will receive will receive Lot 3 JE live attenuated SA 14-14-2 vaccine manufactured in the new GMP facility (250 infants).
| Study group | Role | What they receive |
|---|---|---|
| JE Vaccine existing facilities | Active comparator | will receive JE live attenuated SA 14-14-2 vaccine manufactured in the existing facility (250 infants). Receives: Biological: JE Vaccine existing facility |
| JE vaccine new plant lot 1 | Active comparator | Will receive Lot 1 JE live attenuated SA 14-14-2 vaccine manufactured in the new GMP facility (250 infants). Receives: Biological: JE vaccine new plant lot 1 |
| JE vaccine new plant lot 2 | Active comparator | Will receive Lot 2 JE live attenuated SA 14-14-2 vaccine manufactured in the new GMP facility (250 infants). Receives: Biological: JE vaccine new plant lot 2 |
| JE vaccine new plant lot 3 | Active comparator | Will receive will receive Lot 3 JE live attenuated SA 14-14-2 vaccine manufactured in the new GMP facility (250 infants). Receives: Biological: JE vaccine new plant lot 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity of different lots of vaccines
JE immunogenicity will be parameterized as the percentage of children with demonstrated seroprotection (defined as a serum antibody titer of ≥ 1:10 as measured by PRNT) at 28 days post-immunization with JE live attenuated SA 14-14-2 vaccine.
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 posted10 Jul 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy InfantsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635816
- Sponsor's protocol ID
- PR-11050
- Status last verified
- Jul 2012
- First submitted
- 4 Jul 2012
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zaman K, Naser AM, Power M, Yaich M, Zhang L, Ginsburg AS, Luby SP, Rahman M, Hills S, Bhardwaj M, Flores J. Lot-to-lot consistency of live attenuated SA 14-14-2 Japanese encephalitis vaccine manufactured in a good manufacturing practice facility and non-inferiority with respect to an earlier product. Vaccine. 2014 Oct 21;32(46):6061-6. doi: 10.1016/j.vaccine.2014.09.012. Epub 2014 Sep 18.
PubMed 25239483
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. 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 Manufactured in a New Good Manufacturing Practices Facility and Non-inferiority With Respect to an Earlier Product.
- ClinicalTrials.gov ID
- NCT01635816
- Acronym / sponsor ID
- PR-11050
- Conditions
- Healthy Infants
- Keywords
- Immunogenicity, SA 14-14-2 JE vaccine, Bangladesh
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 10 Jul 2012 (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 proposed Japanese Encephalitis (JE)Vaccine 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 JE live attenuated SA 14-14-2 vaccine manufactured in a new 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 will enroll a total of 1,000 Bangladeshi infants aged 10 to 12 months. In addition to providing immunogenicity data, JEV05 will provide local safety data of JE live attenuated SA 14-14-2 vaccine among Bangladeshi children. This will be 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.
Detailed description
Vaccination is the most effective intervention to prevent JE and its associated morbidity and mortality (http://www.who.int.nuvi/Je/en). JE live attenuated SA 14-14-2 vaccine has been used in Asia for more than two decades in over 400 million children. Chengdu Institute of Biological Products (CDIBP), a Chinese manufacturer, has been producing JE live attenuated SA 14-14-2 vaccine since 1988. It has been demonstrated to be both safe and immunogenic in several observational and case-control studies providing protection for at least 5 years following a single dose. JE live attenuated SA 14-14-2 vaccine is licensed for use in China, India, Nepal, South Korea, Sri Lanka, and Thailand. Countries that have introduced JE vaccine into their national immunization programs have experienced dramatic reductions in JE incidence, leading WHO to declare vaccination the preferred JE control strategy.4
In order for JE live attenuated SA 14-14-2 vaccine to be available for purchase through UNICEF and GAVI for broader international use, including in Bangladesh, JE live attenuated SA 14-14-2 vaccine needs to undergo WHO prequalification. With technical support from PATH, CDIBP has established a new GMP facility, Building 208 JE production unit, maintaining WHO standards. A GMP Certificate for the new facility was issued on 11/16/2011. This certificate provides market authorization to distribute the new vaccine in China. To achieve WHO prequalification, JE live attenuated SA 14-14-2 vaccine produced in this new GMP facility needs to be shown to be similarly safe and immunogenic to JE live attenuated SA 14-14-2 vaccine produced in the existing facility, the JE viral vaccine production plant, and needs to demonstrate lot-to-lot consistency.
The proposed JEV05 study is a four-arm double-blind randomized controlled single center trial testing the immunogenicity of four lots of JE live attenuated SA 14-14-2 vaccine - three lots manufactured in the new GMP facility and one lot from the existing facility - in a total of 1000 Bangladeshi infants aged 10 to 12 months. The study will be conducted in the Matlab Health and Demographic Surveillance System (HDSS) intervention area, a rural site where many vaccine trials have been conducted.
A 5 ml blood sample will be collected from each child before vaccination and at 28 days post-vaccination. The sera will be tested using a plaque reduction neutralization test (PRNT) with JE neutralizing antibody titers > 1:10 considered seroprotective. The JEV05 trial will provide immunogenicity data on the three vaccine lots produced in the new GMP facility compared to a vaccine lot produced in the prior existing plant. It will also provide local immunogenicity and safety data of JE live attenuated SA 14-14-2 vaccine among Bangladeshi children. This will be 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| JE Vaccine existing facilities | Active comparator | Biological: JE Vaccine existing facilitywill receive JE live attenuated SA 14-14-2 vaccine manufactured in the existing facility (250 infants). |
| JE vaccine new plant lot 1 | Active comparator | Biological: JE vaccine new plant lot 1Will receive Lot 1 JE live attenuated SA 14-14-2 vaccine manufactured in the new GMP facility (250 infants). |
| JE vaccine new plant lot 2 | Active comparator | Biological: JE vaccine new plant lot 2Will receive Lot 2 JE live attenuated SA 14-14-2 vaccine manufactured in the new GMP facility (250 infants). |
| JE vaccine new plant lot 3 | Active comparator | Biological: JE vaccine new plant lot 3Will receive will receive Lot 3 JE live attenuated SA 14-14-2 vaccine manufactured in the new GMP facility (250 infants). |
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 enrollment residing in Matlab HDSS intervention area who have completed all doses of EPI immunizations (BCG, DPT, HBV, Hib, OPV and measles) at least 4 weeks prior to enrollment.
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 enrollment.
- 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 |
|---|---|---|
| JE Vaccine existing facilityWill receive JE live attenuated SA 14-14-2 vaccine manufactured in the existing facility (250 infants). | Biological | JE Vaccine existing facilities |
| JE vaccine new plant lot 1Will receive Lot 1 JE live attenuated SA 14-14-2 vaccine manufactured in the new GMP facility (250 infants). | Biological | JE vaccine new plant lot 1 |
| JE vaccine new plant lot 2Will receive Lot 2 JE live attenuated SA 14-14-2 vaccine manufactured in the new GMP facility (250 infants). | Biological | JE vaccine new plant lot 2 |
| JE vaccine new plant lot 3Will receive will receive Lot 3 JE live attenuated SA 14-14-2 vaccine manufactured in the new GMP facility (250 infants). | Biological | JE vaccine new plant lot 3 |
Primary outcome
Immunogenicity of different lots of vaccines
Time frame: 8 months
JE immunogenicity will be parameterized as the percentage of children with demonstrated seroprotection (defined as a serum antibody titer of ≥ 1:10 as measured by PRNT) at 28 days post-immunization with JE live attenuated SA 14-14-2 vaccine.
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 29 Nov 2016.
- Derived from this study: PubMed 25239483Zaman K, Naser AM, Power M, Yaich M, Zhang L, Ginsburg AS, Luby SP, Rahman M, Hills S, Bhardwaj M, Flores J. Lot-to-lot consistency of live attenuated SA 14-14-2 Japanese encephalitis vaccine manufactured in a good manufacturing practice facility and non-inferiority with respect to an earlier product. Vaccine. 2014 Oct 21;32(46):6061-6. doi: 10.1016/j.vaccine.2014.09.012. Epub 2014 Sep 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 JE Vaccine existing facility, JE vaccine new plant lot 1 and JE vaccine new plant lot 2 in people with Healthy Infants, run by International Centre for Diarrhoeal Disease Research, Bangladesh 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 29 Nov 2016. 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?
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?
Immunogenicity of different lots of vaccines (time frame: 8 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 NCT01635816, which also lists 1 linked publication.
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 Nov 2016.