Live Attenuated Japanese Encephalitis (JE) Vaccine Coadministered With Measles Vaccine in Infants 9 Months of Age

NCT00463684 | Completed Phase 4 Results

• 1 other identifier: JEV03
• Study Type: interventional
• Target: 278
• 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 at 9 months of age. The primary hypothesis was that the seropositivity rate at 28 days post vaccination in Japanese Encephalitis (JE) and measles concomitantly vaccinated subjects 9 months of age is greater than 80% for JE and greater than 90% for measles.

Conditions

Japanese Encephalitis

Outcome Measures

Primary Outcomes (3)

• Number and Percentage of Subjects With Demonstrated Seropositivity for Japanese Encephalitis (JE) Neutralizing Antibodies

  Blood serum was collected immediately before administration (Day 0), Day 28, six months post-administration, 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.

  1 year

• Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Manufacturer Definition

  Blood serum was collected immediately before administration (Day 0), Day 28, six months post-administration, and 1 year later. Serum anti-measles immunoglobulin class G (IgG) antibodies were measured by enzyme-linked immunosorbent assay (ELISA) (Serion ELISA classic Measles Virus IgG, Serion GmbH, Würzburg,Germany). For anti-measles IgG, two definitions of seropositivity were used: per manufacturer's instruction (concentration of\>200 mIU/mL, this table) and when including those with "borderline" results (≥150 mIU/mL).

  1 year

• Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Including Borderline Subjects

  Blood serum was collected immediately before administration (Day 0), Day 28, six months post-administration, and 1 year later. Serum anti-measles immunoglobulin class G (IgG) antibodies were measured by enzyme-linked immunosorbent assay (ELISA) (Serion ELISA classic Measles Virus IgG, Serion GmbH, Würzburg,Germany). For anti-measles IgG, two definitions of seropositivity were used: per manufacturer's instruction (concentration of\>200 mIU/mL) and when including those with "borderline" results (≥150 mIU/mL, this table).

  1 year

Secondary Outcomes (9)

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

  1 year

• Geometric Mean Titer (GMT) of Anti-measles Immunoglobulin G (IgG)

  1 year

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

  1 year

• Number of Solicited Local Reactions to LJEV: Days 0-3

  3 days

• Number of Solicited Local Reactions to LJEV: Days 4-7

  4 days

Study Arms (1)

All subjects

EXPERIMENTAL

Healthy infants 9 months of age (plus or minus 2 weeks) that met the eligibility criteria. Subjects received one dose of Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine (LJEV) and one dose of live, attenuated measles vaccine.

Biological: Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine; Biological: Live, attenuated measles vaccine

Interventions

Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine BIOLOGICAL

Manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China; batch 200611A078-1. Administered subcutaneously in the right brachium.

All subjects

Live, attenuated measles vaccine BIOLOGICAL

Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium.

All subjects

Eligibility Criteria

• Age: 9 Months - 9 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy child 9 months (±2 weeks) 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
• Ministry of Health of Sri Lanka: collaborator
• Mahidol University: collaborator
• Quintiles Singapore: collaborator

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: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 18, 2007
• First Posted: April 20, 2007
• Study Start: July 7, 2007
• Primary Completion: November 7, 2007
• Study Completion: October 6, 2008
• Last Updated: February 8, 2019
• Results First Posted: February 8, 2019

Record last verified: 2018-09

Locations

SR (3)