Dataset Information

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, multicentre, 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 two years (day 720) post-vaccination, 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 inter-changeability study, children receiving two doses of JENVAC® reported significantly higher response compared to two doses of SA 14-14-2. No difference in adverse events was observed. These corroborate with excellent seroprotection post the first dose of an earlier JENVAC® study. CONCLUSIONS:A single dose vaccination with JENVAC® induces protective titres that persist up to one 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 JE vaccine. CLINICAL TRIALS REGISTRATION:(CTRI/2014/02/004386 and CTRI/2016/05/006909).

SUBMITTER: Vadrevu KM

PROVIDER: S-EPMC7529014 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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

Vadrevu Krishna Mohan KM Potula Venugopal V Khalatkar Vasant V Mahantshetty Niranjana S NS Shah Atish A Ella Raches R

The Journal of infectious diseases 20201001 9

<h4>Background</h4>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.<h4>Methods</h4>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 ...[more]

PMID: 31858116

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Project description:Japanese encephalitis (JE) caused by mosquito-borne Flavivirus is one of the leading causes of viral encephalitis in Asia. Control strategies include vector control and human vaccination. Due to lack of immunization programmes in endemic regions, there are still high mortality and morbidity. A live-attenuated SA 14-14-2 JE vaccine (LAJEV) has been licensed and used in Asian countries, including India. We report the assessment of immunogenicity and safety of the vaccine in adults during the first mass adult vaccination campaign carried out in Assam, India.One thousand and seventy five adults (aged ?15 yr) who received LAJEV were monitored for adverse events following immunization for one year. The safety assessment of vaccinated population was evaluated till 28 days and at 6 and 12 months. Blood samples collected from the enrolled participants were tested by plaque reduction neutralization test (PRNT 50 ) to assess the neutralizing antibody titres (NATs) before vaccination and 28 days, six and 12 months post-vaccination (PV).Among the 1075 vaccinated individuals, four reported minor adverse effects from 30 min to 28 days PV. Based on the pre-vaccination NAT, the study participants were categorized as seronegative, moderately seropositive and strongly seropositive. Nearly 85.5 per cent of JE seronegative participants seroconverted by 28 days PV. The geometric mean titre (GMT) in all the three groups increased by 28 days and decreased by six and 12 months PV. Nearly 60 per cent of the moderately positive individuals exhibited four-fold rise in GMT, 28 days PV. Almost 95.5 per cent of the participants in the study population remained seroprotected at the end of 12 months PV.This study on immunogenicity and safety of LAJEV in adults showed that a single dose of the live-attenuated vaccine was safe and induced protective immunity to both JE seronegative and naturally seropositive adults. Further study is required to find out long term protective efficacy of this vaccine.

Project description:BackgroundThe performance of live attenuated Japanese Encephalitis SA 14-14-2 vaccine (CD-JEV) among children previously given inactivated mouse brain-derived JE vaccine (IMBV) is unknown. We evaluated the safety and immunogenicity of CD-JEV administered to 2- and 5-year-old children in Sri Lanka.MethodsIn this open-label, single arm trial in the Colombo District of Sri Lanka, generally healthy children 2 and 5years of age who had previously received two and three doses of IMBV, respectively, were administered one dose of CD-JEV subcutaneously. Participants were monitored for adverse events for one year post-vaccination. Serum neutralizing antibody responses were evaluated pre and 28 and 365days post-vaccination using JE plaque reduction neutralization test and characterized as the proportion of participants seroconverting. Seroconversion was defined as either reaching a titer considered seroprotective (⩾1:10) among participants with a baseline titer <1:10 or achieving at least a 4-fold rise in titer among participants with a baseline titer ⩾1:10.ResultsOf 305 children given CD-JEV, 294 were included in the primary analysis of immunogenicity. Prior to vaccination, 144/147 (98.0%) 2-year-olds and 146/147 (99.3%) 5-year-olds had seroprotective levels. 28days post-vaccination, 79/147 [53.7% (95% CI, 45.3-62.0)] 2-year olds and of 60/147 [40.8% (95% CI, 32.8-49.2)] 5-year olds achieved seroconversion. Among 2-year-olds, geometric mean titers (GMTs) rose from 697 to 3175 28days post-vaccination. Among 5-year-olds, GMTs rose from 926 to 2776. Most adverse reactions were mild, and no serious adverse events were related to study vaccination.ConclusionAdministration of CD-JEV to these children with pre-existing neutralizing JE antibody titers was safe and resulted in substantial boosting of antibody levels. These results may inform other countries in Asia considering switching from IMBV to now WHO-prequalified CD-JEV vaccine to combat this disease of public health importance.

Dataset Information

Persistence of Immune responses with an Inactivated Japanese Encephalitis single-dose vaccine JENVAC® and interchangeability with a live-attenuated vaccine.

Publications

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

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