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

Japanese Encephalitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02821221
• Other study ID #: 2015-JEC13-BR
• Secondary ID: U1111-1143-8142
• Status: Recruiting
• Phase: Phase 3
• First received: June 29, 2016
• Last updated: June 30, 2016
• Start date: June 2015
• Est. completion date: December 2016

Study information

• Verified date: June 2016
• Source: National Institute of Hygiene and Epidemiology, Vietnam
• Contact: Thiem D Vu, MD., PhD.
• Phone: 84913304649
• Email: vdt[@]nihe.org.vn
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Months to 60 Years

Eligibility

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 IEC/IRB 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 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese
• Japanese Encephalitis

Intervention

Biological:
• Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)
0.5 mL, Subcutaneous

Locations

Country	Name	City	State
Vietnam	Hoa Binh Preventive Medicine Center	Hoa Binh

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Hygiene and Epidemiology, Vietnam	Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects reporting solicited injection site reactions, solicited systemic reactions, unsolicited systemic reactions, and serious adverse events occurring throughout the trial	Solicited injection site reactions: Aged < 23 Months Tenderness, Redness, and Swelling. Aged 2 Years and above: Pain Redness and swelling; Solicited systemic reactions: Aged < 23 Months Fever (Temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and Irritability; and unsolicited adverse events. Aged 2 Years and above Fever (Temperature), Headache, Malaise and Myalgia	Day 0 up to Day 28 post-vaccination	Yes
Secondary	Neutralizing antibody titers at baseline and following as IMOJEV® vaccination	The presence of neutralizing antibodies will be measured in all available sera using a JE chimeric virus 50% plaque reduction neutralization test (PRNT50)	Day 0 and Day 28 post vaccination	No
Secondary	Number of participants with seroconversion following IMOJEV® primary vaccination	Seroconversion is defined as JE virus neutralizing antibody titers = 10 (1/dil) in subjects who are seronegative (< 10 [1/dil]) at baseline and by a = 4 fold rise in neutralizing antibody titers in subjects who are seropositive (= 10 [1/dil]) at baseline	Day 0 and Day 28 post vaccination	No
Secondary	Seroprotection status for antibody levels against JE virus before and after primary IMOJEV® vaccination	Seroprotection defined as IMOJEV® neutralizing antibody titer = 10 (1/dil)	Day 0 and Day 28 post vaccination	No