Halloran provided US regulatory guidance for first universal mosquito saliva vaccine to be tested in humans in the US
BOSTON, February 21, 2017 – 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.
About Halloran Consulting Group
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.
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