Clinical trial NCT00621764: Immunogenicity and Safety of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children
Official title: A Controlled Study of the Safety and Immunogenicity of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Japanese Encephalitis
Hepatitis A
Keywords: Japanese encephalitis (JE)
Hepatitis A
Inactivated Mouse-Brain
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-02-22
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Safety:

To describe the safety profiles following vaccination.

Immunogenicity:

To describe the immune response after a single dose of vaccine.

Detailed description: This is a randomized, cross-over, open, active controlled, multi-center trial in toddlers and children in Thailand. Stepwise enrollment of children in 2 age cohorts. Subjects will be followed for 5 years.

Eligibility criteria: Inclusion Criteria:

* Provision of consent form signed by at least one parent or another legally acceptable representative, and by at least one independent witness.
* Completion of vaccinations according to the national immunization schedule
* Subject and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
* Previous receipt of two doses of a mouse-brain-derived JE vaccine at 12 to 15 months of age according to the national immunization schedule and aged 2 to 5 years on the day of inclusion.
* Aged 12 to 24 months on the day of inclusion and have not received any JE vaccine.

Exclusion Criteria:

* Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
* Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances.
* Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
* Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response.
* Receipt of hepatitis A vaccine.
* History of flavivirus infection (confirmed either clinically, serologically or microbiologically).
* Administration of any anti-viral within 2 months preceding the screening visit.
* History of central nervous system disorder or disease.
* Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
* Planned participation in another clinical trial during the present trial period.
* Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
* Planned receipt of any vaccine in the 4 weeks following any trial vaccination.
* Personal human immunodeficiency virus, hepatitis B or hepatitis C seropositivity in the blood sample taken at screening.
* Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination.
* Previous vaccination against flavivirus disease at any time before the trial other than a mouse-brain-derived JE vaccine given in a two-dose regimen at 12 to 15 months of age in accordance with the national immunization schedule.
* Febrile illness or any acute illness/infection on the day of vaccination, according to investigator judgment
* History of seizures.
* Previous vaccination against flavivirus disease.

Primary outcomes:
measure: Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection
timeFrame: Day 0 up to Day 14 post-vaccination
measure: Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection
timeFrame: Day 0 up to Day 14 post-vaccination
Secondary outcomes:
measure: Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination
timeFrame: Day 0 (pre-vaccination) and Day 28 after final vaccination
measure: Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination
timeFrame: Day 0 (pre-vaccination) and Day 28 after final vaccination
Other outcomes:
measure: Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination
timeFrame: Day 0 (pre-vaccination) up to 5 years after final vaccination
measure: Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine
timeFrame: Day 0 (pre-vaccination) up to 5 years after final vaccination
Locations:
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
Study officials:
affiliation: Sanofi Pasteur SA
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Chokephaibulkit K, Sirivichayakul C, Thisyakorn U, Sabchareon A, Pancharoen C, Bouckenooghe A, Gailhardou S, Boaz M, Feroldi E. Safety and immunogenicity of a single administration of live-attenuated Japanese encephalitis vaccine in previously primed 2- to 5-year-olds and naive 12- to 24-month-olds: multicenter randomized controlled trial. Pediatr Infect Dis J. 2010 Dec;29(12):1111-7. doi: 10.1097/INF.0b013e3181f68e9c.
citation: Feroldi E, Boaz M, Yoksan S, Chokephaibulkit K, Thisyakorn U, Pancharoen C, Monfredo C, Bouckenooghe A. Persistence of Wild-Type Japanese Encephalitis Virus Strains Cross-Neutralization 5 Years After JE-CV Immunization. J Infect Dis. 2017 Jan 15;215(2):221-227. doi: 10.1093/infdis/jiw533.
citation: Chokephaibulkit K, Sirivichayakul C, Thisyakorn U, Pancharoen C, Boaz M, Bouckenooghe A, Feroldi E. Long-term follow-up of Japanese encephalitis chimeric virus vaccine: Immune responses in children. Vaccine. 2016 Nov 4;34(46):5664-5669. doi: 10.1016/j.vaccine.2016.09.018. Epub 2016 Sep 27.