An Open-Label, Single-Treatment, Single-Period, Single Dose, Clinical Phase 1 Study To Assess The Safety And Tolerability Of Recombinant Hepatitis E Vaccine (Adsorbed) Of M/S Cadila Healthcare Ltd., India In Healthy, Adult, Male, Human Subjects.

开始日期2020-03-23

申办/合作机构

Zydus Lifesciences Ltd.

100 项与重组戊肝疫苗（上海泽润）相关的临床结果

登录后查看更多信息

100 项与重组戊肝疫苗（上海泽润）相关的转化医学

登录后查看更多信息

100 项与重组戊肝疫苗（上海泽润）相关的专利（医药）

登录后查看更多信息

项与重组戊肝疫苗（上海泽润）相关的文献（医药）

2024-09-01·Veterinary Microbiology

Influence of bovine pestivirus heterogeneity on serological responses to 10 different commercial vaccine formulation

Article

作者: Camargo, Luana ; Gomes, Viviani ; Baccili, Camila Costa ; Resende da Silva, Gustavo Feliciano ; Flores, Eduardo Furtado

Bovine Pestivirus typically involves one or more organ systems, with clinical manifestations ranging from mild to severe fatal systemic illness that lead to significant reproductive, productive, and economic losses. Vaccines face the challenge of addressing the significant variability of pestiviruses, which affects the interaction between viral antigens and the immune system's ability to provide protection. This study aimed to evaluate the serological responses against bovine viral diarrhea virus 1 (Pestivirus A) and Pestivirus B induced by 10 commercial vaccines, including one recombinant (vaccine E), two modified live (MLV multivalent, vaccine I, and MLV monovalent, vaccine J), and seven killed vaccines (KLV, vaccines A to H). Additionally, we evaluated the cross-reactivity between Pestivirus A and B from vaccines and HoBi-like pestivirus (Pestivirus H). In Phase 1, guinea pigs were used to screen for non-MLVs. They were divided into nine groups (n=6 each) and received two doses (⅕ of bovine dose) of eight different non-MLV on Days 0 and 21. Serum samples were collected on Days 0 and 30 for serological analyse. In Phase 2, Holstein × Gir heifers (n= 45) were divided into five groups, comprising 6-9 animals. They were vaccinated either once with MLVs or twice with the top non-MLVs screened in Phase 1. Serum samples were harvested on d0 (vaccination day) and d60 (60 days after the first dose) for MLV and non-MLV. Specific antibody titers were assessed virus neutralization (VN) and transformed in log2 for statistical analysis using PROC-MIXED. Significant effects were observed for vaccine groups, time points, and their interactions concerning neutralizing antibodies against Pestivirus A and B in both Guinea pigs and heifers. The Phase 1 study revealed serological responses against Pestivirus A exclusively in non-MLV D (85.33±13.49) and E (72.00±19.26). In the bovine study, the KLD vaccine D (72.00±15.10), recombinant vaccine E (90.66±25.85), and MLV I (170.66±28.22) resulted in an average of neutralizing antibodies against Pestivirus A that exceeded the protective threshold (≥ 60). However,individual analysis of heifers showed a higher frequency of animals presenting titers of Pestivirus A Ab surpassing 32 following vaccination with MLV I and J. None of the vaccine formulations in either study elicited a protective immune response against Pestivirus B or demonstrated cross-reactivity against Pestivirus H.

2014-01-01·The Lancet1区 · 医学

Should we screen blood products for hepatitis E virus RNA ?

1区 · 医学

Letter

作者: Samuel, Didier ; Roque-Afonso, Anne-Marie ; Dhumeaux, Daniel ; Pawlotsky, Jean-Michel ; Féray, Cyrille

218 www.thelancet.com Vol 383 January 18, 2014 4 Coilly A, Haim-Boukobza S, Roche B, et al. Posttransplantation hepatitis E: transfusiontransmitted hepatitis rising from the ashes. Transplantation 2013; 96: e4–6. 5 Zhu FC, Zhang J, Zhang XF, et al. Effi cacy and safety of a recombinant hepatitis E vaccine in healthy adults: a large-scale, randomised, double-blind placebo-controlled, phase 3 trial. Lancet 2010; 376: 895–902. Since 2012, five cases of chronic hepatitis E transmitted through blood transfusions were diagnosed (out of 367 transplantations) in the Paul Brousse Centre (Villejuif, France) and Creteil liver transplant centre (Creteil, France). Treatment of chronic hepatitis E infection in liver transplant recipients is decreasing immunosuppression and ribavirin. In these patients, eradication of hepatitis E is not always obtained by antiviral drugs, and substantial liver damage might persist, even after viral clearance. Transfusion of blood products not screened for hepatitis E is associated with a risk of chronic hepatitis E infection in immunocompromised patients. Two recombinant hepatitis E vaccines have successfully gone through phase 3 trials, but they are not yet available and their effi cacy on hepatitis E genotype 3 is unknown. In view of the prevalence of hepatitis E infection in the general population (and therefore in potential blood donors) and the severe consequences of hepatitis E infection in immunocompromised patients, we believe that systematic screening of blood products for markers of hepatitis E infection should be implemented in countries where hepatitis E is endemic, including Germany, Sweden, and France. Because serological testing is poorly sensitive, hepatitis E nucleic acid testing should be considered.

2012-10-15·The Journal of Infectious Diseases2区 · 医学

A Phase 1/2 Clinical Trial Evaluating Safety and Immunogenicity of a Varicella Zoster Glycoprotein E Subunit Vaccine Candidate in Young and Older Adults

2区 · 医学

Article

作者: Ventzislav Vassilev ; Edouard Ledent ; Thomas C. Heineman ; Geert Leroux-Roels ; Isabel Leroux-Roels ; Pierre Vandepapelière ; Frédéric Clement

BACKGROUNDAn adjuvanted recombinant varicella zoster virus (VZV) subunit vaccine is being developed for the prevention of herpes zoster and its complications.METHODSIn a phase I/II, open-label, randomized, parallel-group study, older adults (50-70 years) received 2 doses 2 months apart of an adjuvanted recombinant glycoprotein E vaccine (HZ/su; n = 45), a live attenuated Oka strain VZV vaccine (OKA; n = 45), or HZ/su and OKA administered concomitantly (n = 45). To evaluate safety prior to administration in older adults, young adults (18-30 years) were vaccinated with 2 doses 2 months apart of HZ/su (n = 10) or OKA (n = 10). Safety and immunogenicity were assessed up to 42 months for older adults immunized with HZ/su and up to 12 months for all others.RESULTSFew grade 3 events and no severe adverse events were reported. Fatigue, myalgia, headache, and injection site pain were the most common solicited reactions for HZ/su and occurred more frequently than with OKA. CD4(+) T-cell and humoral immune responses were much higher with HZ/su than with OKA and remained elevated until 42 months. Addition of OKA to HZ/su did not increase immunogenicity.CONCLUSIONSIn this study, HZ/su adjuvanted subunit vaccine was well tolerated and more immunogenic than a live attenuated VZV vaccine. Clinical Trial registration. NCT00492648 and NCT00492648.

100 项与重组戊肝疫苗（上海泽润）相关的药物交易

登录后查看更多信息