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

Summary

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.

Timeline

Start

2016-10

Primary completion

2017-07

Completion

2017-12

Publications

• Ascough S, Vlachantoni I, Kalyan M, Haijema BJ, Wallin-Weber S, Dijkstra-Tiekstra M, Ahmed MS, van Roosmalen M, Grimaldi R, Zhang Q, Leenhouts K, Openshaw PJ, Chiu C. Local and Systemic Immunity against Respiratory Syncytial Virus Induced by a Novel Intranasal Vaccine. A Randomized, Double-Blind, Placebo-controlled Clinical Trial. Am J Respir Crit Care Med. 2019 Aug 15;200(4):481-492. doi: 10.1164/rccm.201810-1921OC.

Drugs

Indications