Study of a Single Primary Dose Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) in Healthy Subjects

Immunogenicity and Safety of a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®) Given to Healthy Subjects in Vietnam

The purpose of this study is to describe the immunogenicity and safety of IMOJEV® in adult and pediatric populations in Vietnam and serve a bridging study to compare immunogenicity, reactogenicity, and safety data obtained with IMOJEV® in the Vietnamese population with data from other Asian pediatric populations.

Primary objective:

- To describe the safety profile of a single dose of IMOJEV®.

Secondary objectives:

• To evaluate the immune response to JE 28 days after the administration of a single dose of IMOJEV® in healthy Vietnamese subjects aged from 9 months to 60 years.

Study Overview

• Status: Completed
• Conditions: Japanese Encephalitis
• Intervention / Treatment: Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)

Detailed Description

Study participants will be enrolled by age group and will each receive one injection of IMOJEV® on Day 0 given as primary vaccination. They will be assessed for immunogenicity and safety, post-vaccination.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 3

Contacts and Locations

Study Locations

• Vietnam
  • Hoa Binh, Vietnam
    • Preventive Medicine Centre of Hoa Binh Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 58 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged 9 months through 60 years on the day of inclusion.
• For adults: Informed consent form has been signed and dated by the subject. For minors: Informed consent form has been signed and dated by the parent or legally acceptable representative. In addition, in accordance with the Institution Ethics Committee / Institution Review Board requirements and as appropriate for the age of the subject, the subject may be required to sign and date the informed consent form if aged 12 to 17 years or assent form if aged 8 to 11 years.
• Subject and parent(s)/legally acceptable representative(s) are able to attend all scheduled visits and comply with all study procedures.

Exclusion Criteria:

• Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination).
• Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or a medical procedure.
• Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following the study vaccination, except for inactivated influenza vaccination, which may be received at least 2 weeks before the study vaccine
• Previous vaccination against flavivirus disease, including Japanese Encephalitis (JE), dengue, and yellow fever.
• Receipt of immune globulins, blood, or blood-derived products in the past 3 months that might interfere with the assessment of the immune response.
• Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy (for more than 2 consecutive weeks within the 4 weeks preceding vaccination).
• History of flavivirus infection (confirmed either clinically, serologically, or virologically).
• History of central nervous system disorder or disease, including seizures.
• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the study or to a vaccine containing any of the same substances.
• Known thrombocytopenia, contraindicating vaccination.
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating vaccination.
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
• Current alcohol abuse or drug addiction.
• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion.
• Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment. A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
• Receipt of any chronic anti-viral in the 2 months preceding the study vaccination or planned receipt of any anti-viral in the 4 weeks following the study vaccination. Short-term antiviral drugs for flu or herpes can be administered provided there is a wash-out period of 1 week before the administration of the vaccine.
• Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Age 9 Months through 4 Years Group; Participants age 9 Months through 4 Years old at enrollment	Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®); 0.5 mL, Subcutaneous; Other Names: IMOJEV®
Experimental: Age 5 Years through 11 Years Group; Participants age 5 Years through 11 Years old at enrollment	Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®); 0.5 mL, Subcutaneous; Other Names: IMOJEV®
Experimental: Age 12 Years through 17 Years Group; Participants age 12 Years through 17 Years old at enrollment	Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®); 0.5 mL, Subcutaneous; Other Names: IMOJEV®
Experimental: Age 18 Years through 60 Years Group; Participants age 18 Years through 60 Years old at enrollment	Biological: Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®); 0.5 mL, Subcutaneous; Other Names: IMOJEV®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)	Solicited injection-site: ≤ 23 months age: Tenderness, Erythema, and Swelling. For ≥ 2 years age: Pain, Erythema, and Swelling. Solicited systemic reactions: ≤ 23 months age, Fever (temperature) Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability, For ≥ 2 years age, Fever (temperature) Headache, Malaise, and Myalgia. Grade 3: Tenderness, Cries when injected limb is moved; Pain, Incapacitating, unable to perform usual activities or Significant; prevents daily activity (≥ 12 years); Erythema and Swelling (≤23 months to 11 years), ≥50 mm or >100 mm (≥ 12 years). Grade 3 Fever, > 39.5°C (≤ 23 months) or ≥39.0°C (≥ 2 years); Vomiting, ≥ 6 episodes per 24 hours; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time; Appetite loss, Refuses ≥ 3 feeds / meals; Irritability, Inconsolable. Headache, Malaise, and Myalgia, Significant; prevents daily activity.	Day 0 up to Day 14 post-vaccination
Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)	Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroprotection was defined as antibody titer levels ≥10 (1/dil).	Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of Participants With Japanese Encephalitis Seroconversion Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)	Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dil) and post-vaccination titer ≥10 (1/dil) or participants with pre vaccination titer ≥10 (1/dil) and a ≥4-fold increase from pre- to post-vaccination.	Day 0 (pre-vaccination) and Day 28 post-vaccination
Summary of Geometric Mean Titers of Japanese Encephalitis Antibodies Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)	Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50).	Day 0 (pre-vaccination) and Day 28 post-vaccination

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company
• Collaborators: National Institute of Hygiene and Epidemiology, Vietnam

Publications and helpful links

General Publications

• Vu TD, Nguyen QD, Tran HTA, Bosch-Castells V, Zocchetti C, Houillon G. Immunogenicity and safety of a single dose of a live attenuated Japanese encephalitis chimeric virus vaccine in Vietnam: A single-arm, single-center study. Int J Infect Dis. 2018 Jan;66:137-142. doi: 10.1016/j.ijid.2017.10.010. Epub 2017 Nov 27.

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: July 5, 2015
• First Submitted That Met QC Criteria: July 5, 2015
• First Posted (Estimate): July 8, 2015

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Japanese Encephalitis; IMOJEV®; Japanese encephalitis chimeric virus vaccine; Live attenuated vaccine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Encephalitis, Japanese; Encephalitis; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: JEC13; U1111-1143-8142 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org