Immunogenicity and Safety of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children

Hepatitis A Clinical Trial

Official title:

A Controlled Study of the Safety and Immunogenicity of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00621764
• Other study ID #: JEC01
• Status: Completed
• Phase: Phase 2
• First received: February 12, 2008
• Last updated: September 23, 2014
• Start date: March 2008
• Est. completion date: May 2013

Study information

• Verified date: September 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Safety:

To describe the safety profiles following vaccination.

Immunogenicity:

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2013
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 5 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese
• Hepatitis
• Hepatitis A
• Japanese Encephalitis

Intervention

Biological:
• Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)
=4.0 Log10 Plaque forming units (PFU), Subcutaneous (SC; Day 0); 0.5 mL intramuscular (IM; Day 28)
• Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)
0.5 mL IM (Day 0); =4.0 Log10 PFU SC (Day 28)
• Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)
=4.0 Log10 PFU SC (Day 0); 0.5 mL IM (Day 28)
• Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)
0.5 mL IM (Day 0); =4.0 Log10 PFU SC (Day 28)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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- t — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination	Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay.	Day 0 (pre-vaccination) up to 5 years after final vaccination	No
Other	Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine	Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay.	Day 0 (pre-vaccination) up to 5 years after final vaccination	No
Primary	Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection	12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, =5 cm; Fever, >39.5°C; Vomiting, = 6 times/day; Abnormal crying, >3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses =3 feeds/meals; Irritability, Inconsolable.; 2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, =5 cm; Fever, >39°C; Headache, Malaise, and Myalgia, Prevents activities.	Day 0 up to Day 14 post-vaccination	No
Primary	Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection	12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, =5 cm; Fever, >39.5°C; Vomiting, = 6 times/day; Abnormal crying, >3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses =3 feeds/meals; Irritability, Inconsolable.; 2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, =5 cm; Fever, >39°C; Headache, Malaise, and Myalgia, Prevents activities.	Day 0 up to Day 14 post-vaccination	No
Secondary	Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination	JE virus neutralizing antibody measurement was assessed by 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 4-fold increase from pre- to post-vaccination.	Day 0 (pre-vaccination) and Day 28 after final vaccination	No
Secondary	Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination	JE virus neutralizing antibody measurement was assessed by the PRNT50 assay.	Day 0 (pre-vaccination) and Day 28 after final vaccination	No