RSV001 - A New Vaccine to Prevent Severe Viral Chest Infections.
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Infections; Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): PanAd3-RSV given intra-nasally (high dose); MVA-RSV given by intra-muscular injection (high dose); PanAd3-RSV given by intra-muscular injection (high dose); PanAd3-RSV given intranasally (low dose); MVA-RSV given by intra-muscular injection (low dose); PanAd3-RSV given by intra-muscular injection (low dose)
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 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
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Respiratory Syncytial Virus; RSV; Vaccine