A Dose‐Escalation Safety and Immunogenicity Study of Live Attenuated Oral Rotavirus Vaccine 116E in Infants: A Randomized, Double‐Blind, Placebo‐Controlled Trial

Abstract

Three administrations of vaccine doses of 1 X 10(4) ffu and 1 X 10(5) ffu were safe. The 1 X 10(5)-ffu dose of 116E demonstrated a robust immune response after 3 administrations. These favorable results warrant further development of the vaccine candidate and provide optimism that vaccinating infants in the developing world will prevent serious sequelae of rotavirus infection. Clinical trials registration. NCT00439660 and ISRCTN57452882 .

Rotavirus Infection: A Perspective on Epidemiology, Genomic Diversity and Vaccine Strategies

“…This strain is a natural reassortant between a human rotavirus virus G9P [11] strain with the VP4 protein from a bovine rotavirus strain and was originally isolated from a neonate with an asymptomatic rotavirus infection [10]. A recent randomized double blinded placebo controlled trial for this stain has demonstrated that the vaccine elicits a strong immune response in Indian children [11]. This study, as well as previous studies, did not find any association with vaccination and adverse events [10,11].…”

“…A recent randomized double blinded placebo controlled trial for this stain has demonstrated that the vaccine elicits a strong immune response in Indian children [11]. This study, as well as previous studies, did not find any association with vaccination and adverse events [10,11]. Phase 3 trials of the 116E vaccine in India are in progress.…”

“…However, uncommon strains like G1P [4], G2P [8], G4P [4], G9P [6] and G9P [8] were found in smaller frequencies. In contrast, an epidemiological survey conducted in India from 1986 to 1988, showed that 70% of strains belonged to the unusual combination of G9P [11] [29,74]. A survey conducted in 1993 showed equal distribution of the common strain G2P [4] and the unusual strain G9P [6], which were found in 21 and 24% of isolates, respectively in India [4,74].…”

“…One candidate is based on a neonatal rotavirus strain, 116E, and is being developed by Bharat Biotech International Limited. This strain is a natural reassortant between a human rotavirus virus G9P [11] strain with the VP4 protein from a bovine rotavirus strain and was originally isolated from a neonate with an asymptomatic rotavirus infection [10]. A recent randomized double blinded placebo controlled trial for this stain has demonstrated that the vaccine elicits a strong immune response in Indian children [11].…”

Progress with rotavirus vaccines: summary of the Tenth International Rotavirus Symposium

“…This strain was originally isolated from a neonate with an asymptomatic rotavirus infection in New Delhi, India. The 116E vaccine demonstrated good immunogenicity in Indian children [18], and is currently in the late stages of a Phase III efficacy trial with results expected in 2013. Earlier in the pipeline are vaccines being developed by the Serum Institute of India and Shantha Biotechnics based on the UK bovine-human reassortant strains.…”