Persistence of Immune Responses With an Inactivated Japanese Encephalitis Single-Dose Vaccine, JENVAC and Interchangeability With a Live-Attenuated Vaccine

Abstract

Background This study reports immunogenicity, safety, and interchangeability of a single-dose, inactivated, Vero-cell derived, JENVAC to the live-attenuated SA 14-14-2 vaccine in healthy children. Methods This phase 4, multicenter, open-label, randomized, control trial enrolled 360 children who were equally randomized to receive a single dose of either JENVAC or SA 14-14-2. Children were followed at various time points, until 2 years (day 720) postvaccination, upon which a subset from each group was divided and allocated to a receive a booster dose or the other vaccine. Results At all time points, immunological measures were statistically higher in the JENVAC group. In the interchangeability study, children receiving 2 doses of JENVAC reported significantly higher response compared with 2 doses of SA 14-14-2. No difference in adverse events was observed. These corroborate with excellent seroprotection after the first dose of an earlier JENVAC study. Conclusions A single-dose vaccination with JENVAC induces protective titers that persist up to 1 year. We report appreciable interchangeability between both vaccines, with JENVAC/JENVAC combination exhibiting the highest immune response. JENVAC is now licensed as a single-dose Japanese encephalitis vaccine.

Retention of neutralizing antibodies to Japanese encephalitis vaccine in age groups above fifteen years in Korea

“…Neutralizing antibody titer prevalence is proposed to be related to the persistence of antibodies (Dubischar et al, 2017;Vadrevu et al, 2019). The current study was conducted in a JE endemic country where natural exposure to JEV may have affected the outcomes and confirmed high NAb persistence in 1605 participants aged >15 years in South Korea.…”

“…The World Health Organization (WHO) recommends the use of JE vaccine in national immunization programs (NIPs) in all areas where JE is recognized as a public health priority (Heffelfinger et al, 2017). Currently, there are 15 JE vaccines in use globally (Vadrevu et al, 2019).…”

Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial

“… 10 Biosafety level 3 manufacturing facilities and a well established Vero cell manufacturing platform (with proven safety in other licensed live and inactivated vaccines) were used for the rapid development of BBV152. 11 , 12 , 13 , 14 , 15 , 16 …”

Safety and immunogenicity trial of an inactivated SARS-CoV-2 vaccine-BBV152: a phase 1, double-blind, randomised control trial

“…Whole-virion inactivated vaccines have been used for decades and have a well-established safety profile. Bharat Biotech manufactures several Vero cell-derived whole-virion inactivated licensed vaccines (5-7) and two investigational candidates (Zika and Chikungunya). We have accumulated safety data from 4,700 participants across phase 1-3 clinical trials and conducted pharmacovigilance reports on all licensed vaccines (approximately 100 million doses administered).…”

“…The virus strain (NIV-2020-770) isolated from a COVID-19 patient and sequenced at the Indian Council of Medical Research-National Institute of Virology (NIV) was provided to Bharat Biotech. Bio-Safety Level-3 manufacturing facilities and a well-established Vero cell manufacturing platform (with proven safety in other licensed live and inactivated vaccines) aided in the rapid development of BBV152 (3)(4)(5)(6)(7).…”