Immunogenicity of SA 14-14-2 JE Vaccine

NCT01635816 | Completed Phase 4 DMC

• 1 other identifier: PR-11050
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Healthy Infants

Keywords

Immunogenicity; SA 14-14-2 JE vaccine; Bangladesh

Outcome Measures

Primary Outcomes (1)

• 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.

  8 months

Study Arms (4)

JE Vaccine existing facilities

ACTIVE COMPARATOR

will receive JE live attenuated SA 14-14-2 vaccine manufactured in the existing facility (250 infants).

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).

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).

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).

Biological: JE vaccine new plant lot 3

Interventions

JE Vaccine existing facility BIOLOGICAL

Will receive JE live attenuated SA 14-14-2 vaccine manufactured in the existing facility (250 infants).

JE Vaccine existing facilities

JE vaccine new plant lot 1 BIOLOGICAL

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 1

JE vaccine new plant lot 2 BIOLOGICAL

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 2

JE vaccine new plant lot 3 BIOLOGICAL

Will receive will receive Lot 3 JE live attenuated SA 14-14-2 vaccine manufactured in the new GMP facility (250 infants).

JE vaccine new plant lot 3

Eligibility Criteria

• Age: 10 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

Matlab

Chāndpur, Bangladesh

Location

Related Publications (1)

• 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.

  PMID: 25239483 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2012
• First Posted: July 10, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 29, 2016

Record last verified: 2012-07

Locations

BA (1)