Boffito M.,Chelsea and Westminster Hospital NHS Foundation Trust |
Fox J.,Guys and St Thomas Hospital NHS Trust |
Bowman C.,Royal Hallamshire Hospital |
Fisher M.,University of Sussex |
And 7 more authors.
Vaccine | Year: 2013
Background: Combination antiretroviral therapy (cART) is the main therapeutic management tool for HIV/AIDS. Despite its success in controlling viral load and disease progression, cART is expensive, associated with a range of significant side effects and depends for its efficacy on the patient's life-long commitment to high levels of treatment adherence. Immunotherapeutic agents can provide potential solutions to these shortcomings. Here we describe a Phase Ib trial of HIV-v, a synthetic immunotherapy that elicits T- and B-cell effector responses against HIV infected cells. Methods: Fifty-nine cART-naive HIV-infected males aged 18-50 years with viral load of 5000-500,000. copies/ml and CD4 counts >350/μl were recruited for this multi-centre, randomised, double blind study. Volunteers received one low (250. μg) or high (500. μg) dose of HIV-v, either alone or adjuvanted (ISA-51). Safety, immunogenicity, CD4 count and viral load were monitored over 168 Days. Results: HIV-v was well tolerated and the adjuvanted formulations elicited IgG responses in up to 75% of volunteers. The high adjuvanted dose also elicited cellular responses in 45% of tested volunteers. In these responding subjects viral loads were reduced by over 1. log ( p= 0.04) compared to Placebo and non-responders. No changes in CD4 count were observed. Conclusions: HIV-v is safe and can elicit T- and B-cell responses in ART-naive HIV patients that significantly reduce viral load. Improved dosing regimens and further research on long term efficacy are required, but HIV-v appears to have potential as an immunotherapeutic anti-viral agent.Trial registered as EudraCT-2009-010593-37 (ClinicalTrials.gov Identifier: NCT01071031). © 2013 Elsevier Ltd.
News Article | February 21, 2017
BOSTON--(BUSINESS WIRE)--Halloran Consulting Group, a national consultancy that helps medical device, biotech, & pharma companies with FDA clinical, quality & regulatory compliance projects, announces the successful submission of an Investigational New Drug (IND) application by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, for a novel vaccine designed to prevent infection of mosquito-transmitted disease, such as Zika, malaria, West Nile virus and dengue, and to hinder transmission of such infections. NIAID has initiated a Phase 1 clinical trial to test the safety of the investigational universal mosquito-borne disease vaccine and its ability to prompt an immune response. The investigational vaccine, called AGS-v, was developed by the London-based SEEK Group, who sought Halloran’s expertise and guidance with regard to US regulatory support and strategy for approval through the US Food & Drug Administration (FDA). Halloran represented SEEK in meetings with NIAID and FDA and co-presented the clinical trial program to the FDA. Working in tandem with SEEK scientists, Halloran developed the justification for a safe starting dose in humans, based on the prior experience with the technology currently being utilized by SEEK in clinical stage products for Flu (FLU-v) and HIV (HIV-v) under development in Europe. Additionally, Halloran provided assistance to SEEK regarding a phase-appropriate GMP framework for the chemistry, manufacturing and controls (CMC) section of the planned IND with FDA. During the IND submission process, Halloran brought years of experience to assist SEEK in the development of the CMC IND section. “ Mosquito-borne diseases cause millions of deaths every year according to the World Health Organization. In 2015, malaria alone caused 438,000 deaths. Outbreaks of Zika virus disease have been reported in Africa, the Americas, Asia and the Pacific. Since 2015, 62 countries and territories have reported mosquito transmitted Zika virus. Halloran is pleased to have successfully supported SEEK with the regulatory activities required to initiate a Phase 1 study of their vaccine which may protect populations against multiple mosquito-borne diseases,” said Halloran principal consultant, Michelle Rose. The technology behind AGS-v identifies antigenic targets in mosquito saliva that facilitate the transfer of pathogens from host (mosquito) to target (human) and uses those targets as a vaccine in humans. According to NIAID, the vaccine contains four synthetic protein fractions from mosquito salivary glands. The proteins are designed to induce antibodies and to change the response against mosquito saliva that can prevent infection when mosquitoes carrying disease take a blood meal (bite). “ Halloran has provided invaluable regulatory support and guidance in taking a very novel product into humans for the first time in an unprecedented accelerated program that was fitting given the magnitude of public health threats caused by the Zika pandemic and mosquito diseases in general,” said Gregory Stoloff, CEO of SEEK Group. The trial will enroll up to 60 healthy adults aged 18-50 years and take place at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland. Investigators expect to enroll all participants by August 2017 and to complete the study around June 2018. For further information on trial parameters, visit the NIAID website, here. Halloran Consulting Group is a management consulting firm that partners with life science companies to optimize their development. Halloran works with industry organizations of all types, including biotech, pharma, medical device, and service providers, to identify gaps and implement solutions to achieve excellence in regulatory, quality, and clinical development. Halloran is certified by the Women’s Business Enterprise National Council as a woman-owned business. For more information, please visit www.hallorancg.com.
News Article | February 21, 2017
Vaccine could protect against diseases such as Zika and Malaria; hVIVO's joint venture investment with SEEK in a new company, Imutex, was formed to accelerate the development of this vaccine LONDON, UNITED KINGDOM--(Marketwired - Feb 21, 2017) - hVIVO plc ( : HVO), a specialty biopharma company with discovery and clinical testing capabilities, notes the announcement from the US National Institute of Health (NIH) that it has initiated a Phase I clinical trial of AGS-v, an investigational mosquito-borne disease vaccine. AGS-v is intended to provide broad protection against a range of mosquito-transmitted diseases, such as Zika, malaria, West Nile fever and dengue fever, and to hinder the ability of mosquitoes to transmit such infections. The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, is leading the trial, which will enrol up to 60 healthy adults ages 18-50 years, and is designed to test the safety of the investigational vaccine, as well as its ability to prompt an immune response in human subjects. In 2016, hVIVO formed a joint venture with London-based SEEK Group (SEEK) in a new company, Imutex Limited (Imutex), to accelerate the development of SEEK's AGS-v vaccine and broad-spectrum influenza vaccine (BIV), FLU-v. Such vaccines are key public health priorities identified by the Centers for Disease Control and Prevention (CDC), the NIH, and other international health authorities. SEEK, through its parent company PepTcell Limited, has a clinical trial agreement with NIAID to conduct the Phase I study at the NIH Clinical Center in Bethesda, Maryland under the direction of Matthew J. Memoli, M.D., Director of the Clinical Studies Unit in NIAID's Laboratory of Infectious Diseases. Unlike other vaccines targeting specific mosquito-borne diseases, AGS-v is designed to trigger an immune response to mosquito saliva rather than a specific virus or parasite carried by mosquitoes. The test vaccine contains four synthetic proteins from mosquito salivary glands. The proteins are designed to induce antibodies in a vaccinated individual and to cause a modified allergic response that can prevent infection when a person is bitten by a disease-carrying mosquito. Kym Denny, CEO of hVIVO, commented, "This vaccine has the potential to shift the balance of power in the fight against mosquito-borne disease, and is an excellent example of the UK's ability to translate insightful science into a potentially ground-breaking product. We are excited to commence the Phase I study with our partners at SEEK under the excellent stewardship of the team at NIAID, and I look forward to reporting progress on the trial in the coming year." The full NIH press release can be found here: About hVIVO plc hVIVO plc ("hVIVO"), a specialty biopharma company with discovery and clinical testing capabilities, is pioneering a human-based analytical platform to accelerate drug discovery and development in respiratory and infectious diseases. Leveraging human disease models in flu, RSV and asthma exacerbation, the hVIVO platform captures disease in motion, illuminating the entire disease life cycle from healthy to sick and back to health. Based in the UK, market leader hVIVO has conducted more than 45 clinical studies, inoculated over 2000 volunteers and has three first-in-class therapies currently in development with a growing pre-clinical pipeline.