title: Single-dose, live-attenuated Japanese encephalitis vaccine in children aged 12-18 months: randomized, controlled phase 3 immunogenicity and safety trial.
abstract: This trial in 1200 JE-vaccination naïve children (age 12-18 mo) in Thailand and the Philippines aimed to demonstrate consistency of three successive industrial scale manufacturing lots of live attenuated Japanese encephalitis chimeric virus vaccine (JE-CV) and consistency between industrial scale manufacturing lots and a fourth, development lot. Children received JE-CV from one of three successive industrial scale lots produced in Thailand (n = 899), or from a fourth development lot produced in the USA (n = 199), or hepatitis A control vaccine (n = 102). Antibodies were assessed by 50% plaque reduction neutralization test (PRNT(50)) at screening and Day 28. Seroconversion rates (titer of < 10 at baseline and ≥ 10 on Day 28, or a four-fold rise from a baseline titer of ≥ 10) were determined per group. Lot-to-lot consistency of seroconversion rate and GMT was demonstrated between the 3 industrial scale lots, and between these lots and the US lot. Seroconversion rate on pooled data 28 d after JE-CV vaccination (Thai lots) was 95.0% [95% confidence interval (CI); 93.3-96.3]. The safety profile of JE-CV was favorable and comparable with hepatitis A vaccine. There were no serious adverse events related to vaccination. This study demonstrated the consistency of three successive industrial scale JE-CV vaccine lots, as well as consistency with a development lot. The study also demonstrated that a single dose of JE-CV is well tolerated and elicits a high protective immune response, seroconverting 95% of JE-naïve Asian children aged 12-18 mo.
authors: Sanofi Pasteur Clinical Development Department, Marcy l'Etoile, France. Emmanuel.feroldi@sanofipasteur.com
authors: Emmanuel
authors: E
authors: Feroldi
authors: Chitsanu
authors: C
authors: Pancharoen
authors: Pope
authors: P
authors: Kosalaraksa
authors: Veerachai
authors: V
authors: Watanaveeradej
authors: Kerdpanich
authors: K
authors: Phirangkul
authors: Maria R
authors: MR
authors: Capeding
authors: Mark
authors: M
authors: Boaz
authors: Sophia
authors: S
authors: Gailhardou
authors: Alain
authors: A
authors: Bouckenooghe
mesh_terms: D057134:Antibodies, Neutralizing / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D004672:Encephalitis, Japanese / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007223:Infant; D022321:Japanese Encephalitis Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D008297:Male; D010679:Philippines; D013785:Thailand; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D010948:Viral Plaque Assay
chemical_list: D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D022321:Japanese Encephalitis Vaccines; D014613:Vaccines, Attenuated