Determining Long-Term Safety and Efficacy of Japanese Encephalitis Vaccine When Given With Measles Vaccine

NCT00412516 | Completed Phase 3 Results

• 1 other identifier: JEV02
• Study Type: interventional
• Target: 519
• Locations: 1 country
• Sites: 1

Brief Summary

The previously conducted JEV01 study looked at the immunogenicity and safety of the concurrent administration of Japanese Live Attenuated SA 14-14-2 and measles vaccines at the one month post vaccination time point. The purpose of the JEV01 study was to help ensure the safety of SA 14-14-2 simultaneously administered with measles vaccine, paving the way for its use in routine EPI programs. As a follow-on to JEV01, this study will enroll those infants who received both vaccines and completed the JEV01 study. This study, however, will provide crucial data to help ensure the long-term immunogenicity of the concurrent administration of these vaccines and provide valuable information to determine the use of these vaccines in routine immunization programs. This study is planned because in the original protocol for JEV01, long-term data points were not included. The hypothesis is that children who receive JE live attenuated SA 14-14-2 vaccine and measles vaccine at the same time have long-term (24 and 36 months post vaccination) protection against these diseases at the same level as those who receive the vaccines at different intervals.

Conditions

Encephalitis, Japanese B

Keywords

Japanese Encephalitis; Japanese B Encephalitis; Japanese B Viral Encephalitis; Viral Encephalitis, Japanese B

Outcome Measures

Primary Outcomes (1)

• Measles Seropositivity at 24 and 36 Months

  Seropositivity defined as an anti-MV IgG concentration of 120 mIU/mL determined with the Siemens ELISA

  24, 36 months post vaccination

Secondary Outcomes (3)

• Measles Seropositivity at 12 Months

  12 months post vaccination

• Seropositive Rate for Japanese Encephalitis (JE) Antibody in Infants in the Philippines Who Received Measles Vaccine (MV) Before, With, or After SA 14-14-2 JE Vaccination by Month After JE Vaccination.

  12 months, 24 months, and 36 months post vaccination

• Geometric Mean Neutralizing Antibody Titer to Japanese Encephalitis (JE) Virus in Infants in the Philippines Who Received Measles Vaccine (MV) Before, With, or After SA 14-14-2 JE Vaccination by Month After JE Vaccination.

  12, 24, 36 months post-JE vaccination

Study Arms (3)

Group 1

OTHER

JE live attenuated SA 14-14-2 vaccine then measles vaccine after one month

Biological: Live attenuated SA 14-14-2 vaccine

Group 2

EXPERIMENTAL

JE live attenuated SA 14-14-2 vaccine and measles vaccine concurrently

Biological: Live attenuated SA 14-14-2 vaccine

Group 3

OTHER

Measles vaccine then JE live attenuated SA 14-14-2 vaccine after one month

Biological: Live attenuated SA 14-14-2 vaccine

Interventions

Live attenuated SA 14-14-2 vaccine BIOLOGICAL

Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 20 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participant was enrolled in the JEV01 study previously conducted at RITM.
• Participant completed his/her vaccination schedule for the JEV01 study previously conducted at RITM.
• Participant's blood test results from JEV01 study indicate that he/she had seroconverted to measles vaccination.
• Participant's parents or legal guardian are/is willing to provide signed informed consent.

You may not qualify if:

• Participant was withdrawn from the JEV01 study for any reason.
• Receipt of immune globulin or other blood products within 6 months of study (JEV02) entry or receipt of injected or oral corticosteroids or other immune modulator therapy (except routine vaccines) within 4 weeks of study (JEV02) entry.
• Any condition that in the opinion of the investigator, would interfere with the evaluation of the study objectives.

Sponsors & Collaborators

• PATH: lead

Study Sites (1)

Research Institute for Tropical Medicine (RITM)

Manila, Philippines

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: Anthony A Marfin, Director Japanese Encephalitis Vaccine Introduction and Sustainability Project
• Organization: PATH

aamarfin@path.org

2062853500

Study Officials

• Salvacion Gatchalian, MD

  Research Institute for Tropical Medicine (RITM)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2006
• First Posted: December 18, 2006
• Study Start: December 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: October 13, 2014
• Results First Posted: October 6, 2014

Record last verified: 2014-10

Locations

PH (1)