A Phase IV Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Inactivated Japanese Encephalitis Vaccine in healthy volunteers. - JENVAC

Start Date24 Feb 2020

Sponsor / Collaborator

Bharat Biotech International Ltd.

100 Clinical Results associated with Inactivated Japanese encephalitis vaccine(Biological E. Ltd.)

100 Translational Medicine associated with Inactivated Japanese encephalitis vaccine(Biological E. Ltd.)

100 Patents (Medical) associated with Inactivated Japanese encephalitis vaccine(Biological E. Ltd.)

Literatures (Medical) associated with Inactivated Japanese encephalitis vaccine(Biological E. Ltd.)

01 Jun 2024·Heliyon

Novel envelope protein time-resolved fluoroimmunoassay as an alternative in vitro potency assay for quality control of inactivated Japanese encephalitis virus vaccine

Article

Author: Lin, Guanfeng ; Cao, Yue ; Li, Zhaoyue ; Zhai, Xiangming ; Gao, Xuzhe ; Liu, Shiyuan ; Wu, Yingsong ; Zhang, Zhigao ; Sun, Feifei ; Zhao, Hui

Japanese encephalitis (JE) vaccination is the most effective way to prevent JE. Plaque reduction neutralization test (PRNT) as the standard method for potency testing for inactivated JE vaccine could not provide the exact potency value. Envelope (E) protein of JE virus induces the body to create neutralizing antibodies. There is a potential for using the determination of E protein to assess the immunogenicity and efficacy of JE vaccine. In this study, an automatic time-resolved fluoroimmunoassay for detection of E protein in JE vaccine was established as a simple and rapid in vitro potency assay to complement PRNT, including the expression and paired screening of monoclonal antibodies, the establishment of assay method and performance verification. A pair of anti-E protein neutralizing antibodies (L022 and L034) were screened to construct the sandwich detection pattern. After pre-treating the vaccine sample, the entire analysis was performed using a fully automated machine, which had a little detection time and eliminated manual error. The results of the validation experiment met the requirements for quality control. The linear range was from 0.78125 U/mL to 25 U/mL, the sensitivity was 0.01 U/mL, the intra-assay coefficient of variation was less than 5 %, and the inter-assay coefficient of variation was less than 10 %. The recovery from the dilution was between 90 % and 110 %. This present TRFIA shown good stability and effectiveness in quality control for samples related to JE vaccine production. The outcomes demonstrated that the present TRFIA could be an alternative in vitro potency assay in quality control for inactivated JE vaccine.

01 Apr 2022·HLA

Association of HLA‐DM and HLA class II genes with antibody response induced by inactivated Japanese encephalitis vaccine

Article

Author: Liang, Jiangli ; Han, Xue ; Shi, Li ; Chen, Jun ; He, Jihong ; Sun, Mingbo ; Yao, Yufeng ; Liu, Shuyuan ; Gu, Qin

HLA class II molecules, HLA‐DR, DP and DQ, together with HLA II‐like protein DM, play a dominant role in the processing and presentation of antigens, which may influence vaccine effectiveness. We previously demonstrated that variations in the HLA‐DRB1, DPB1 and DQB1 genes may affect the neutralising antibody (NAb) response induced by the inactivated Japanese encephalitis vaccine (IJEV). In the present study, we genotyped HLA‐DPA1, DQA1, DMA and DMB genes and used previous HLA‐DRB1, DPB1 and DQB1 data to evaluate the association of these genes with IJEV‐induced NAbs, at both the seroconversion and geometric mean titres (GMTs). We confirmed the seropositive association of DQB1*02:01 and NAbs (0.156 vs. 0.075, p_adj = 0.018; OR = 2.270; 95% CI = 1.285–3.999) and seronegative association of DQB1*02:02 (0.014 vs. 0.09, p_adj = 0.0002; OR = 0.130; 95% CI = 0.047–0.400). Furthermore, the DMB*01:03–DMA*01:01–DPA1*01:03–DPB1*04:01 haplotype was associated with a negative response (0.020 vs. 0.074; p_adj = 0.03; OR = 0.250; 95% CI = 0.097–0.649), whereas DRB1*15:02–DMB*01:01–DMA*01:01 was associated with a positive response (0.034 vs. 0; p_adj = 0.044). In addition, DRB1*12:02, DRB1*13:02, DPB1*04:01, DPB1*05:01, DPB1*09:01, DQA1*06:01 and DQA1*01:02 were associated with a higher GMT of NAbs, whereas DRB1*11:01, DPB1*13:01 and DQA1*05:05 were associated with a lower GMT of NAbs. In conclusion, the present study suggests that variations in the HLA‐DM and HLA class II genes, as well as their combined allotypes, may influence the IJEV NAbs at seroconversion and GMT levels.

01 Feb 2022·The Lancet Microbe

Safety and dose-sparing effect of Japanese encephalitis vaccine administered by microneedle patch in uninfected, healthy adults (MNA-J): a randomised, partly blinded, active-controlled, phase 1 trial

Article

Author: Oyamada, Takayoshi ; Kakita, Kosuke ; Iwata, Hiroaki ; Yamaguchi, Yasuyuki ; Takashima, Shota ; Imafuku, Keisuke ; Taguchi, Kenji ; Haga, Naoya

BACKGROUNDIt is unclear whether microneedle vaccinations of Japanese encephalitis virus can induce sufficient neutralising antibodies and reduce the amount of vaccine needed. We aimed to assess the safety and dose-sparing effect of a microneedle vaccine patch against Japanese encephalitis in healthy individuals who are naive to both the vaccine and natural infection.METHODSThe MNA-J study was a randomised, partly blinded, active-controlled, phase 1 clinical trial at Hokkaido University (Sapporo, Japan) that enrolled healthy adults aged 20-34 years with no history of Japanese encephalitis vaccination nor of infection as confirmed by seronegativity. We excluded individuals who had been infected with or vaccinated against Japanese encephalitis. Eligible participants were randomly assigned (1:1:1) to one of three groups to receive inactivated Japanese encephalitis vaccine administered twice, 3 weeks apart, by either 2·5 μg per injection by subcutaneous injection, 0·63 μg per patch by high-dose microneedle array (MNA-25%), or 0·25 μg per patch by low-dose microneedle array (MNA-10%). The randomisation sequence, using stratification by cohort and blocks of six, was computer-generated by a statistician who was unaware of group assignment. After administration, the remaining amount of unadministered vaccine was measured by ELISA and calculated as the delivered amount of vaccine. The primary outcome was the neutralising antibody titre at day 42 after first immunisation. Successful seroconversion was defined as post-vaccination titres of 1·3 (log₁₀) or higher in individuals whose pre-vaccination titres had been less than 1 (log₁₀). This study is registered with the Japan Registry of Clinical Trials (s011190004).FINDINGSBetween Aug 31 and Sept 2, 2019, 39 participants were enrolled and each was randomly assigned to a group (n=13 per group). No serious adverse events were observed. All participants in the microneedle array groups had a localised erythematous reaction. The amount of vaccine delivered by microneedle array to each participant was 0·63-1·15 μg (50-92%) of the full 1·26 μg for the MNA-25% group and 0·25-0·41 μg (51-84%) of the full 0·50 μg for the MNA-10% group. All participants demonstrated seroconversion at day 42, and the mean titres (log₁₀) were 2·55 for MNA-25%, 2·04 for MNA-10%, and 2·08 for subcutaneous injection.INTERPRETATIONA microneedle patch of the Japanese encephalitis vaccine is safe, well tolerated, and immunogenically effective. The dose-sparing effect suggests a significant potential to reduce the amount of immunogens needed. However, improved delivery is needed to make it more tolerable and user friendly.FUNDINGFUJIFILM.

100 Deals associated with Inactivated Japanese encephalitis vaccine(Biological E. Ltd.)

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Encephalitis, Viral	-	Biological E. Ltd.	01 Feb 2015

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