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最高研发阶段临床2期 |
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非在研适应症- |
最高研发阶段临床1期 |
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Randomized, Doubleblind, Placebo-controlled Trial in Healthy Adults of Safety and Immunogenicity of 2 Intranasal Doses of SynGEM®, an RSV Candidate Vaccine Containing F Glycoprotein Linked to a Bacterium-like-Particle (BLP) Carrier
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.
A Phase 1, randomized, double-blind, controlled trial to evaluate the safety and immunogenicity of increasing intranasal doses or of three intramuscular doses of the adjuvant Gram-positive Enhancer Matrix (GEM) administered with a standard dose of trivalent inactivated influenza vaccine (TIV) antigens, compared to a standard dose of TIV antigens administered either intranasally or intramuscularly in healthy adult volunteers; followed by a randomized, double-blind, controlled evaluation of safety - FluGem in healthy adult and elderly volunteers
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