Phase I Study for SynGEM, an Intranasal Respiratory Syncytial Virus (RSV) Prefusion F Subunit Candidate Vaccine

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2016
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 μg F-protein/2mg BLPs) and a high dose level ( 350 μg 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.
Epistemonikos ID: 600a150fbcc2c73d76838ac4641c522c07e128c5
First added on: Mar 23, 2020