In this study we are testing a new vaccine against Respiratory Syncytial Virus (RSV). This virus can cause respiratory infections such as bronchiolitis and pneumonia. It affects all ages, but especially infants, adults with a suppressed immune system, and the elderly. RSV only infects humans and occurs in epidemics each winter. It is the single most common cause of severe respiratory illness in children. There is no effective anti-viral medication to treat RSV infections. There is a monoclonal antibody, which can be given to 'at-risk' children given by injection on a monthly basis during winter to provide short term protection against infection, but it is only partially effective and prohibitively expensive. Currently, there is no licensed vaccine to prevent RSV infection and there remains a real need to develop a vaccine as a cost-effective method to save lives and reduce the cost of disease caused by RSV.
We are testing two new RSV vaccines, given in different combinations and by different routes of administration. Each vaccine uses the same RSV proteins to stimulate immune responses. These proteins are the F (Fusion), N (Nucleocapsid) and M2-1 (Matrix) proteins. The F protein sits on the surface of the virus and is needed to infect human cells. Antibodies to this protein are an important mechanism to prevent infection. The N and M2-1 proteins are needed for viral replication and are targets of immune recognition. The two vaccines in this study contain all three of these proteins. However, they are delivered into the body using different 'vectors', which are harmless carrier viruses. In this study, we have employed two different vectors:a simian adenoviruses (PanAd3) and Modified Vaccinia virus Ankara (MVA). We administer these vaccines using a 'prime-boost' strategy, in which one of these vaccines is used to 'prime' the immune system, which is then 'boosted' 4 or 8 weeks later, depending on the groups, by administration of an alternative vaccine or the same vaccine given by a different route.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
72
High dose = 5x10\^10 vp
High dose = 1x10\^8 pfu
High dose = 5x10\^10 vp
Low dose = 5x10\^9 vp
Low dose = 1x10\^7 pfu
Low dose = 5x10\^9 vp
Centre for Clinical Vaccinology & Tropical Medicine (CCVTM)
Oxford, Oxfordshire, United Kingdom
Safety
The recording and assessment of local and systemic adverse events following administration of each vaccine dose; * Fever * Headache * Nausea and/or vomiting * Malaise * Myalgia * Arthralgia * Injection site adverse events (for IM administered vaccine); pain or tenderness, induration, redness and swelling * Nasal site adverse events (for IN administered vaccine); pain or tenderness, irritation and discharge * Blood parameters * Any unsolicited symptom(s) not listed above
Time frame: 52 Weeks
Immunogenicity
Immunological assays to study immune responses to each vaccine, including: * Serum antibody response to RSV F antigen * Serum antibody response capable of RSV neutralization * Quantification of circulating vaccine-induced B-cell secreting antibodies (IgA and IgG) against RSV F antigen * Quantification of circulating vaccine-induced T-cell responses against RSV antigens F, N and M2-1 * Any further exploratory immunology to detect vaccine related immune responses
Time frame: 52 weeks
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