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The study in 48 healthy adults will assess the safety and immunogenicity of a prime-boost regime of two different intranasal doses of the RSV vaccine, SynGem.
Biotech company, Mucosis, announced that it has initiated a first-in-human study of its intranasal respiratory syncytial virus (RSV) vaccine candidate, SynGem, at Imperial College London’s Clinical Research Facility in the United Kingdom.
The randomized, double-blind study, which involves 48 healthy adults (36 vaccinated, 12 placebo), will assess the safety and immunogenicity of a prime-boost regime of two different intranasal doses of SynGem. Phase I will be completed at day 180 post prime vaccine administration, with interim data expected in the first half of 2017. Mucosis plans begin Phase II evaluation in mid 2017 and will recruit 108 adults (54 vaccinated, 54 placebo) for the trial.
SynGem is based on a unique pre-fusion version of the F subunit of RSV, which has shown to raise more potent serum neutralizing antibodies against RSV compared with the post-fusion F antigen approach used by other companies. The Mucosis vaccine is delivered via the mucous membranes in the nose. According to Mucosis, its 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, which is thought to the entry route for more than 90% of pathogens into 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.
The Wellcome Trust awarded Mucosis with a €3.44 million (£2.77 million) translational fund earlier in 2016 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.