Date: 2016-11-07
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Mucosis (The Netherlands)
Product: SynGEM®
Action
mechanism: vaccine. SynGEM® is based on a unique prefusion version of the F subunit of RSV, shown to raise more potent serum neutralizing antibodies against RSV compared with the postfusion F antigen approach others have used. Delivered via the mucous membranes in the nose, the Mucosis vaccine candidate is also able to recruit antibodies produced in the mucosal linings of the body, with the potential to effectively stop the virus from entering the body via the mucosal pathways, where over 90% of pathogens enter the body. SynGEM® is based on Mucosis’ patented Mimopath® technology, which uses bacterium-like particles (BLP) derived from food-grade bacteria, to deliver the antigen in a more natural conformation and boost the body’s immune response to the virus.
Disease: Respiratory Syncytial Virus (RSV) infection
Therapeutic area: Infectious diseases
Country: UK
Trial
details: The study is a double-blind (within dose level), placebo-controlled Phase I study to assess the safety, reactogenicity and tolerability of two intranasal dose levels of SynGEM®: a low dose level (140 ?g F-protein/2mg BLPs) and a high dose level ( 350 ?g F-protein/5mg BLPs), each administered twice according to a prime-boost schedule 28 days apart at Day 1 and Day 29. The two dose levels will be recruited sequentially. Immunogenicity end-points will include assessment of humoral and cellular responses at selected time-points. (NCT02958540)
Latest
news: * On November 7, 2016, Mucosis announced the start of a first-in-human study of its intranasal Respiratory Syncytial Virus (RSV) vaccine candidate, SynGEM®, at Imperial College London’s Clinical Research Facility. The first trial will recruit 48 healthy adults (36 vaccinated, 12 placebo) to assess the safety and immunogenicity of a prime-boost regime of two different intranasal doses of SynGEM®, in a randomised, double-blind Phase I study. Phase I is completed at day 180 post prime vaccine administration, with interim data readout expected in the first half of 2017. Phase II, due to start mid-2017, will recruit 108 adults (54 vaccinated, 54 placebo). The Wellcome Trust awarded Mucosis with a €3.44 million (£2.77 million) translational fund earlier in the year to progress SynGEM® into phase I and IIa human clinical trials. On completion of the phase I study, a phase IIa study will involve a live viral challenge to assess the efficacy of SynGEM against RSV.
