A Phase 1 Randomized, Placebo-controlled, Observer-blind Trial to Assess the Safety and Immunogenicity of a Nipah Vaccine, HeV-sG-V (Hendra Virus Soluble Glycoprotein Vaccine), in Healthy Adults

A first-in-human, phase 1 trial is to be conducted in a healthy adult population in the US to assess the safety and immunogenicity of three ascending Nipah vaccine (HeV-sG-V; Hendra virus soluble glycoprotein vaccine) dosages. Different dosing regimens and number of doses will also be explored.

开始日期2020-02-18

申办/合作机构

Auro Vaccines LLC初创企业

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100 项与 HeV sG V 相关的临床结果

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100 项与 HeV sG V 相关的转化医学

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100 项与 HeV sG V 相关的专利（医药）

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123

项与 HeV sG V 相关的文献（医药）

2024-12-01·Vaccine

Raising the case of hepatitis E: Report from the 2nd international HEV symposium

Article

作者: Hong, Chloe ; Marks, Florian ; Kirkwood, Carl D. ; Aziz, Asma Binte ; Chung, Eun ; Kang, Sophie ; Kirkwood, Carl D

The 2nd International Hepatitis E Virus Symposium was held on April 28 and 29, 2023, in London, UK. The conference was hosted by the International Vaccine Institute and brought together key clinicians, researchers, and private and public stakeholders for a dedicated forum on hepatitis E virus (HEV). The scientific program spanned multiple facets of HEV, from updates on clinical research and diagnostic advances to vaccine development. The conference highlighted presentations on several critical HEV vaccine studies that will greatly impact the field, including the largest effectiveness study of Hecolin vaccine outside of China and the first reactive mass-vaccination campaign in South Sudan. This report summarizes information shared at the convening and offers perspectives on the steps forward for hepatitis E.

2024-09-01·Gastroenterology

An Immunocompetent Mongolian Gerbil Model for Hepatitis E Virus Genotype 1 Infection

Article

作者: Xia, Changyou ; Zheng, Liwei ; Yuan, Disen ; Lu, Fengmin ; Zhang, He ; Yang, Xinyue ; Li, Yuebao ; Wang, Lin ; Lu, Qinghui ; Liu, Tianxu ; He, Qiyu ; Yin, Xin ; Tang, Tianyu ; Chen, Xiangmei ; Wei, Guochao ; Guan, Guiwen

BACKGROUND & AIMSHepatitis E virus (HEV), primarily genotype 1 (HEV-1), causes approximately 20.1 million infections, 44,000 deaths, and 3000 stillbirths annually. Current evidence indicates that HEV-1 is only transmitted in humans. Here, we evaluated whether Mongolian gerbils can serve as animal models for HEV-1 infection.METHODSMongolian gerbils were used for HEV-1 and hepatitis E virus genotype 3 infection experiments. HEV infection parameters, including detection of HEV RNA and HEV antigen, liver function assessment, and histopathology, were evaluated.RESULTSWe adapted a clinical isolate of HEV-1 for Mongolian gerbils by serial passaging in feces of aged male gerbils. The gerbil-adapted strain obtained at passage 3 induced a robust, acute HEV infection, characterized by stable fecal virus shedding, elevated liver enzymes, histopathologic changes in the liver, and seroconversion to anti-HEV. An infectious complementary DNA clone of the adapted virus was generated. HEV-1-infected pregnant gerbils showed a high rate of maternal mortality and vertical transmission. HEV RNA or antigens were detected in the liver, kidney, intestine, placenta, testis, and fetus liver. Liver and placental transcriptomic analyses indicated activation of host immunity. Tacrolimus prolonged HEV-1 infection, whereas ribavirin cleared infection. The protective efficacy of a licensed HEV vaccine was validated using this model.CONCLUSIONSHEV-1 efficiently infected Mongolian gerbils. This HEV-1 infection model will be valuable for investigating hepatitis E immunopathogenesis and evaluating vaccines and antivirals against HEV.

2024-08-01·The Lancet Global Health

Safety and effectiveness of a recombinant hepatitis E vaccine in women of childbearing age in rural Bangladesh: a phase 4, double-blind, cluster-randomised, controlled trial

Article

作者: Stene-Johansen, Kathrine ; Zaman, Khalequ ; Øverbø, Joakim ; Clemens, John D ; Qadri, Firdausi ; Aziz, Asma Binte ; Rahman, Mustafizur ; Laake, Ida ; Yunus, Md ; Khanam, Mahbuba ; Haque, Warda ; Sandbu, Synne ; Gurley, Emily S ; Bhuiyan, Taufiqur R ; Dembinski, Jennifer L ; Dudman, Susanne ; Julin, Cathinka Halle

BACKGROUNDHepatitis E virus (HEV) leads to high mortality in pregnant women in low-income countries. We aimed to evaluate the safety of a HEV vaccine and its effectiveness in preventing hepatitis E during pregnancy.METHODSIn this phase 4, double-blind, cluster-randomised trial, 67 villages in Matlab, Bangladesh, were randomised 1:1 to receive HEV239 (a recombinant HEV vaccine) or a control vaccine (Hepa-B, a hepatitis B vaccine), using block randomisation with random number tables and blocks of size eight, stratified by cluster population size. Eligible non-pregnant women (aged 16-39 years) were vaccinated intramuscularly on day 0, at 1 month, and at 6 months, and followed up for 2 years after the last immunisation. The primary endpoint was hepatitis E in the pregnant, per-protocol population (those who received all three doses within 2 days of the scheduled dates), while safety was a secondary endpoint, assessed in the intention-to-treat (ITT) population (participants who received at least one dose). Solicited adverse events were recorded for the first 7 days after each dose, and unsolicited events until 2 years after a participant's final dose. Pregnancy-related safety outcomes were assessed in the pregnant ITT population. This study is registered with ClinicalTrials.gov (NCT02759991).FINDINGSBetween Oct 2, 2017, and Feb 28, 2019, 19 460 participants were enrolled and received either HEV239 (9478 [48·7%] participants, 33 clusters) or Hepa-B (9982 [51·3%] participants, 34 clusters), of whom 17 937 (92·2%) participants received three doses and 17 613 (90·5%) were vaccinated according to protocol (8524 [48·4%] in the HEV239 group and 9089 [51·6%] in the control group). No pregnant participants were confirmed to have hepatitis E in either treatment group. HEV239 showed a mild safety profile, similar to Hepa-B, with no difference in the proportion of solicited adverse events between groups and no severe solicited events. Pain was the most common local symptom (1215 [12·8%] HEV239 recipients and 1218 [12·2%] Hepa-B recipients) and fever the most common systemic symptom (141 [1·5%] HEV239 recipients and 145 [1·5%] Hepa-B recipients). None of the serious adverse events or deaths were vaccine related. Among pregnant participants, the HEV239 group had a higher risk of miscarriage (136 [5·7%] of 2407 pregnant participants) compared with the control group (102 [3·9%] of 2604; adjusted odds ratio 1·54 [95% CI 1·15-2·08]).INTERPRETATIONThe effectiveness of HEV239 in pregnant women remains uncertain. HEV239 was safe and well tolerated in non-pregnant women, but findings regarding miscarriage warrant further investigation.FUNDINGResearch Council of Norway; Innovax.

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适应症	最高研发状态	国家/地区	公司	日期
亨尼巴病毒感染	临床1期	美国	Auro Vaccines LLC初创企业	2020-02-18
病毒感染	临床1期	澳大利亚	Commonwealth Scientific & Industrial Research Organisation	-
病毒感染	临床1期	美国	Profectus BioSciences, Inc.	-