Safety and immunogenicity of a novel intranasal RSV vaccine
Research type
Research Study
Full title
A Phase 1, First-in-Humans, randomized, double-blind (within dose level), placebo-controlled trial to evaluate the safety and immunogenicity of two intranasal doses of SynGEM®, an intranasal Respiratory Syncytial Virus (RSV) subunit candidate vaccine based on the F glycoprotein linked to an immunostimulatory Bacterium-like-Particle (BLP) carrier administered 28 days apart in adult healthy volunteers
IRAS ID
209391
Contact name
Christopher Chiu
Contact email
Sponsor organisation
Mucosis B.V
Eudract number
2015-003814-25
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
Respiratory syncytial virus (RSV) is one of the most important causes of infection of the upper airway and lung in the world. In children older than 5 years of age and young adults, RSV disease typically causes a mild-to-moderate cold. However, in the elderly, patients with chronic lung disease or problems with their immune system, and in very young infants (under 2 years of age), RSV disease is much more common and may lead to severe lung infection, with often serious life-threatening complications. This leads to an estimated 199,000 deaths in children every year. While vaccines are likely to be the best way to control this disease worldwide, no vaccine against RSV is currently available.
The main aim of this study is to find out if the experimental new RSV vaccine SynGEM® is safe and well tolerated. This vaccine is delivered by a spray in the nose and will be studied at two dose levels. The study will also look at the development of antibodies and other immune responses in the blood and nose following vaccination.
This study will be performed in healthy volunteers, aged 18 to 49 years. Forty-eight participants will be enrolled at one site in the UK. Two different doses of the vaccine will be tested. Participants will either receive a high dose or a low dose, or a placebo. Participants will be in the trial for approximately 7 months.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
16/SC/0441
Date of REC Opinion
30 Aug 2016
REC opinion
Favourable Opinion