Boosterability of Live Attenuated Japanese Encephalitis (JE) Vaccine in Children Who Have Previously Received Inactivated JE Vaccine

NCT00463476 | Completed Phase 4 Results

• 1 other identifier: JEV04
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 3

Brief Summary

To facilitate introduction of live attenuated SA 14-14-2 Japanese encephalitis vaccine (LJEV) into the National Immunization Programme of Sri Lanka, we evaluated the safety and immunogenicity of co-administration of LJEV and measles vaccine in children at 2 and 5 years of age. The primary hypothesis was that the seropositivity rate at 28 days post vaccination of SA 14-14-2 in subjects 2 and 5 years of age who have already received at least two doses of mouse brain-derived inactivated JE vaccine is greater than 80%. Japanese encephalitis virus is the leading cause of viral neurological disease and disability in Asia. The severity of sequelae, together with the volume of cases, make JE the most important cause of viral encephalitis in the world. Approximately 3 billion people-including 700 million children-live in areas at risk in Asia for JE. JE most commonly infects children between the ages of 1 and 15 years, and can also infect adults in areas where the virus is newly introduced. More than 50,000 cases are reported annually and cause an estimated 10,000 to 15,000 deaths. This figure is believed to represent only a small proportion of the disease burden that actually exists.

Conditions

Japanese Encephalitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Demonstrated Seropositivity for Japanese Encephalitis (JE) Neutralizing Antibodies

  Blood serum was collected immediately before administration (Day 0), Day 28, and 1 year later. Serum neutralizing antibodies to the Beijing-1 JE strain were measured by plaque reduction neutralization test (PRNT) where the neutralizing titer was measured as the inverse dilution at which plaque counts were reduced by 50%. Seropositivity was defined as a titer of ≥ 1:10.

  Day 0 (pre-vaccination) and 28 days and 1 year post-vaccination

Secondary Outcomes (4)

• Geometric Mean Titer (GMT) of Japanese Encephalitis (JE) Neutralizing Antibodies

  Day 0 and 28 days and 1 year post-vaccination

• Number of Participants With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE)

  Day 0 and 28 days and 1 year post-vaccination

• Number of Participants Experiencing Solicited Local Reactions Up to 3 Days Post-vaccination

  3 days post-vaccination

• Number of Participants Experiencing Solicited Systemic Reactions up to 7 Days Post-vaccination

  7 days post-vaccination

Study Arms (2)

2-year olds

EXPERIMENTAL

Healthy children 2 years of age (±3 months) who had previously received all vaccinations recommended under the Sri Lankan childhood immunization schedule according to their age. Subjects must have previously received inactivated mouse brain-derived Japanese Encephalitis vaccine (IMBV) at the recommended 12 and 13 months of age. Subjects received one dose of Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine (LJEV).

Biological: Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine (LJEV)

5-year olds

EXPERIMENTAL

Healthy children 5 years of age (±3 months) that met all other eligibility criteria. Subjects must have previously received inactivated mouse brain-derived Japanese Encephalitis vaccine (IMBV) at the recommended 12, 13, and 24 months of age. Subjects received one dose of Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine (LJEV).

Biological: Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine (LJEV)

Interventions

Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine (LJEV) BIOLOGICAL

Manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China; batch 200611A078-1. Administered subcutaneously in the right upper arm using 23 gauge needles.

2-year olds; 5-year olds

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy child 2 years (±3 months) or 5 years (±3 months) of age at the enrollment visit.
• Subject was a full-term infant.
• Subject's parent or legal guardian is literate and willing to provide written informed consent.
• Subject is up-to-date for all vaccinations recommended in the Sri Lankan childhood immunization schedule.

You may not qualify if:

• Enrolled in another clinical trial involving any therapy.
• Subject and/or parent(s) or guardian(s) are unable to attend the scheduled visits or comply with the study procedures.
• Received any non-study vaccine within 2 weeks prior to enrolment or refusal to postpone receipt of such vaccines until 28 days after study entry.
• Prior or anticipated receipt of immune globulin or other blood products, or injected or oral corticosteroids or other immune modulator therapy except routine vaccines within 6 weeks of administration of study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \<7 days may be included in the trial as long as they have not received more than one course within the last 2 weeks prior to enrolment.
• History of documented or suspected encephalitis, encephalopathy, or meningitis.
• History of measles.
• History of Japanese encephalitis.
• Serious adverse event related (i.e., possible, probably, definite) to previous receipt of any JE vaccine, if applicable.
• Persistent inconsolable crying (\>3 hours) observed after previous receipt of any JE vaccine, if applicable.
• Hypotonic - hyporesponsiveness after past receipt of any JE vaccine, if applicable.
• Suspected or known hypersensitivity to any of the investigational or marketed vaccine components.
• History of serious chronic disease (cardiac, renal, neurologic, metabolic, or rheumatologic).
• Underlying medical condition such as inborn errors of metabolism, failure to thrive, bronchopulmonary dysplasia, or any major congenital abnormalities requiring surgery or chronic treatment.
• History of thrombocytopenic purpura.
• History of seizures, including history of febrile seizures, or any other neurologic disorder.

Sponsors & Collaborators

• PATH: lead

Study Sites (3)

Homagama MOH Division Medical Office

Homagama, District of Colombo, Sri Lanka

Location

Kolonnawa MOH Division Medical Office

Kolonnawa, District of Colombo, Sri Lanka

Location

Moratuwa MOH Division Medical Office

Moratuwa, District of Colombo, Sri Lanka

Location

MeSH Terms

Conditions

Encephalitis, Japanese

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Mosquito-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Results Point of Contact

• Title: Jorge Flores
• Organization: PATH

jeflores@path.org

(202) 822-0033

Study Officials

• Nihal Abeysinghe, MD, MSc

  Epidemiological Unit, Sri Lanka Ministry of Healthcare and Nutrition

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2007
• First Posted: April 20, 2007
• Study Start: July 9, 2007
• Primary Completion: November 1, 2007
• Study Completion: October 2, 2008
• Last Updated: March 31, 2020
• Results First Posted: March 31, 2020

Record last verified: 2018-09

Locations

SR (3)