title: A Japanese Encephalitis Vaccine From India Induces Durable and Cross-protective Immunity Against Temporally and Spatially Wide-ranging Global Field Strains.
abstract: BACKGROUND
  Japanese encephalitis (JE) is a vaccine-preventable acute disease. We report the results of a phase 2/3 trial of JENVAC, a Vero cell-derived vaccine developed using an Indian strain of JE virus (JEV).
  
  
  METHODS
  JENVAC was administered in 2 doses 28 days apart, and immunogenicity was compared to that from a single dose of SA-14-14-2, the only approved JE vaccine and regimen at the time in India.
  
  
  RESULTS
  After both the doses, seroconversion and seroprotection were >90% for JENVAC. For SA-14-14-2, seroconversion and seroprotection were 57.69% and 77.56%, respectively, on day 28 and 39.74% and 60.26%, respectively, on day 56. The geometric mean titers at day 28 and day 56 were 145.04 and 460.53, respectively, for JENVAC and 38.56 and 25.29, respectively, for SA-14-14-2. With a single dose of JENVAC, seroprotection titers lasted at least 12 months in >80% of the subjects. Following receipt of 2 doses, 61.17% of subjects retained seroprotection titers at 24 months, and immunogenicity criteria were higher than that for SA-14-14-2 at 12, 18, and 24 months each. Sera from JENVAC subjects neutralized JEV genotypes I, II, III, and IV equally well. Adverse events were not significantly different between the 2 vaccines.
  
  
  CONCLUSIONS
  JENVAC elicits long-lasting, broadly protective immunity.
  
  
  BACKGROUND
  CTRI/2011/07/001855.
authors.affiliation: Bharat Biotech International Limited.
authors.forename: Anit
authors.initials: A
authors.lastname: Singh
authors.affiliation: Institute of Child Health, Kolkata.
authors.forename: Monjori
authors.initials: M
authors.lastname: Mitra
authors.affiliation: Institute of Preventive Medicine.
authors.forename: Gadey
authors.initials: G
authors.lastname: Sampath
authors.affiliation: King George Hospital, Visakhapatnam.
authors.forename: P
authors.initials: P
authors.lastname: Venugopal
authors.affiliation: Gandhi Medical College, Secunderabad.
authors.forename: J Venkateswara
authors.initials: JV
authors.lastname: Rao
authors.affiliation: Mysore Medical College.
authors.forename: B
authors.initials: B
authors.lastname: Krishnamurthy
authors.affiliation: Mahatma Gandhi Medical College, Jaipur.
authors.forename: Mukesh Kumar
authors.initials: MK
authors.lastname: Gupta
authors.affiliation: Mahavir Hospital and Research Centre.
authors.forename: S
authors.initials: S
authors.lastname: Sri Krishna
authors.affiliation: Priya Children's Hospital.
authors.forename: B
authors.initials: B
authors.lastname: Sudhakar
authors.affiliation: Sri Sreenivasa Children's Hospital, Vijayavada.
authors.forename: N Bhuvaneswara
authors.initials: NB
authors.lastname: Rao
authors.affiliation: Bharat Biotech International Limited.
authors.forename: Yashpal
authors.initials: Y
authors.lastname: Kaushik
authors.affiliation: Bharat Biotech International Limited.
authors.forename: K
authors.initials: K
authors.lastname: Gopinathan
authors.affiliation: Ella Foundation, Hyderabad.
authors.forename: Nagendra R
authors.initials: NR
authors.lastname: Hegde
authors.affiliation: Gorakhpur Unit, National Institute of Virology, India.
authors.forename: Milind M
authors.initials: MM
authors.lastname: Gore
authors.affiliation: Bharat Biotech International Limited.
authors.forename: V
authors.initials: V
authors.lastname: Krishna Mohan
authors.affiliation: Bharat Biotech International Limited.
authors.forename: Krishna M
authors.initials: KM
authors.lastname: Ella
mesh_terms: D000293:Adolescent; D000328:Adult; D057134:Antibodies, Neutralizing / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002675:Child, Preschool; D003429:Cross Reactions; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D004664:Encephalitis Virus, Japanese / Q000145:classification / Q000235:genetics / Q000276:immunology*; D005260:Female; D006801:Humans; D064789:Immunity, Heterologous; D007194:India; D007223:Infant; D022321:Japanese Encephalitis Vaccines / Q000008:administration & dosage / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D008969:Molecular Sequence Data; D012367:RNA, Viral / Q000235:genetics; D017422:Sequence Analysis, DNA; D014611:Vaccination / Q000379:methods; D055815:Young Adult
chemical_list: D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D022321:Japanese Encephalitis Vaccines; D012367:RNA, Viral
keywords: Japanese encephalitis; cross-protection; durable immunity; genotype; indigenous strain; vaccine