Safety and immunogenicity of Bio Pox™, a live varicella vaccine (Oka strain) in Indian children: A comparative multicentric, randomized phase II/III clinical trial. Issue 9 (2nd September 2017)

• Record Type: Journal Article
• Authors: Dubey, Anand Prakash; Faridi, Mohammad Moonis Akbar; Mitra, Monjori; Kaur, Iqbal Rajinder; Dabas, Aashima; Choudhury, Jaydeep; Mukherjee, Mallar; Mishra, Devendra
• Is Part Of: Human vaccines & immunotherapeutics. Volume 13:Issue 9(2017)
• Page Start: 2032
• Page End: 2037
• Publication Date: 2017-09-02
• Subjects: chickenpox -- Glycoprotein Enzyme Linked Immunoassay (Gp ELISA) -- immunogenicity -- seroconversion -- safety -- Varicella; Vaccines -- Periodicals; 615.372
• DOI: 10.1080/21645515.2017.1318236
• Languages: English
• ISSNs: 2164-5515

Abstract

ABSTRACT: Varicella or chickenpox is a highly contagious disease with a high secondary attack rate. Almost 30% of Indian adolescents lack protective antibodies against varicella, emphasizing the need of routine varicella immunization. The Oka VZV is a well-established, safe and efficacious vaccine strain that is highly immunogenic and produces lifelong protective immunity. The present multicentric, open label, randomized, controlled Phase II/III study, compared the Bio Pox™ (indigenous investigational vaccine) with a licensed vaccine, Varivax™ [a], for its safety and immunogenicity profile in 252 healthy subjects in the age group of 1–12 y (cohort I: 6–12 years, II:1–6 years) in 3 tertiary medical institutions. Antibodies were measured by VZV Glycoprotein Enzyme Linked Immunoassay (IgG ELISA) kit. Seroconversion percentage in children having pre-vaccination anti VZV IgG titer <10 mIU/mL (< 5 gp ELISA units/mL) were 80% for Bio Pox™ and 77% for Varivax™ ( p = 0.692). The seroconversion rate in the group receiving Bio Pox™ was non-inferior to the group that received Varivax™. There were mild local reactions for both the vaccines; none of the patient had fever or required hospitalization or medication. The Bio Pox™ was found to be safe and immunogenic in children against VZV infection.