title: Safety and immunogenicity of single dose live attenuated varicella vaccine (VR 795 Oka strain) in healthy Indian children: a randomized controlled study.
abstract: Varicella, an acute viral systemic infection that may cause lifelong latent infection with the potential for causing clinical reactivation, may be prevented by immunization. The present study was an open label, randomized, controlled, phase III, multicentre trial, conducted to evaluate and compare the safety, tolerability and immunogenicity of a freeze dried live attenuated Oka strain Varicella Vaccine (VR 795 Oka strain) with Varilrix (Oka-RIT strain) in children. A total of 268 healthy Indian children aged 12 months to 12 y with baseline VZV IgG antibody (<100 mIU/ mL) were enrolled, and 256 children completed the study. The extent of rise of VZV IgG antibody titer assessed as 3-fold and 4-fold rise from baseline was found to be significantly higher (89.1% and 85.2%) in the test group as compared to control group (73.4% and 61.7%). The post-vaccination GMT of the test group was significantly higher (112.5 mIU/mL) as compared with the control group (67.8 mIU/mL) (P < 0.001). The seroconversion rate considering the 5 gp ELISA units/ml equivalent to 10mIU/ml were similar in the control (96.5%) and the test (98.3%) groups. The adverse events were not different in the control and test groups (P > 0.05). The test live attenuated vaccine was found to be highly immunogenic, safe and comparable to Varilrix used in control arm.
authors.affiliation: a Institute of Child Health ; Kolkata , India.
authors.forename: Monjori
authors.initials: M
authors.lastname: Mitra
authors.forename: Mma
authors.initials: M
authors.lastname: Faridi
authors.forename: Apurba
authors.initials: A
authors.lastname: Ghosh
authors.forename: Nitin
authors.initials: N
authors.lastname: Shah
authors.forename: Raju
authors.initials: R
authors.lastname: Shah
authors.forename: Suparna
authors.initials: S
authors.lastname: Chaterjee
authors.forename: Manish
authors.initials: M
authors.lastname: Narang
authors.forename: Nisha
authors.initials: N
authors.lastname: Bhattacharya
authors.forename: Gandhali
authors.initials: G
authors.lastname: Bhat
authors.forename: Harish
authors.initials: H
authors.lastname: Choudhury
authors.forename: Ganesh
authors.initials: G
authors.lastname: Kadhe
authors.forename: Amey
authors.initials: A
authors.lastname: Mane
authors.forename: Sucheta
authors.initials: S
authors.lastname: Roy
mesh_terms: D000914:Antibodies, Viral / Q000097:blood*; D019433:Chickenpox Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D002648:Child; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D007194:India; D007223:Infant; D008297:Male; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D019433:Chickenpox Vaccine; D007074:Immunoglobulin G; D014613:Vaccines, Attenuated
keywords: AE, Adverse events; CBC, Complete blood count; Chicken pox; GMT, Geometric mean titer; IIT, Intention- to- treat; Oka Strain; PP, Per protocol; SAE, Serious AE; SST, Serum-separating tube; VZV, Varicella Zoster Virus; Varicella vaccine; immunogenicity; live attenuated vaccine