RSV Study in Adults 60 to 75 Years of Age
Condition: RSV Infection
MeSH terms: Infections; Respiratory Syncytial Virus Infections
Study type: Interventional

Summary: 
      The purpose of this study is to infect healthy volunteers aged 60-75 years old with
      Respiratory Syncytial Virus (RSV) to confirm how safe and well tolerated the use of an
      experimental RSV virus is in a population that has not previously received the virus.
      Additionally, this study will also look at various components of the volunteers' blood, the
      lining of their noses and other samples in order to measure the effects of the virus on the
      body, in particularly the immune system before, during and after viral infection.
    

Detailed description: 
      RSV is a common virus that affects all human age groups. Typical RSV illness is identified by
      symptoms such as runny nose, stuffy nose, sneezing, sore throat, earache, malaise or
      tiredness, cough, shortness of breath, headache, muscle ache, joint ache or stiffness,
      chilliness and feverishness. RSV spreads easily from person to person through the eyes, nose
      or mouth when droplets containing the virus, such as those from coughing or sneezing, are
      inhaled or passed to others. Adults with risk factors, like another illness or disease, may
      experience an RSV illness that is more severe or lasts longer. RSV may also start a worsening
      of health in frail adults, people with weak immune systems, and those with chronic
      cardio-pulmonary disease.

      No treatment or vaccine to treat or prevent RSV disease is available in the UK. Vaccination
      against RSV has the potential to be a highly beneficial and effective approach to reduce RSV
      disease in older adults as well as other high-risk adult and paediatric populations. The use
      of RSV human viral challenge model provides an important tool to evaluate the effectiveness
      of new RSV vaccines. Specifically, a RSV human viral challenge in 60 to 75-year-old
      individuals would enable measuring the effectiveness of RSV vaccines in a population that is
      thought to be less responsive to vaccines than the 18-45-year-old population.

      The purpose of this study is to infect up to 74 healthy subjects aged 60 to 75 years old with
      RSV in a controlled quarantine environment to confirm how safe and well tolerated the use of
      an experimental RSV virus infection is in a population that has not previously received the
      virus. Additionally, the investigators will also look at various components of the subjects'
      blood, the lining of their noses and other samples in order to measure the effects of the
      virus on the body, in particularly the immune system before, during and after viral
      infection.

      The study will consist of 3 phases: 1) Screening, 2) Quarantine and 3) Follow-up.

      The enrolment of the subjects will be staggered with safety data reviews performed between
      groups. Each volunteer will be in the study for approximately 3 months from screening to
      their last scheduled clinic visit.
    

Intervention name(s): Challenge virus RSV-A Memphis 37b
Intervention type(s): Other
Intervention description(s): Each subject will receive one titre of virus, which will be up to approximately 4.5 log10 PFU.
Intervention model: Single Group Assignment
Intervention model description: Each subject will receive one titre of the Challenge Virus intranasally.
Masking: None (Open Label)
Primary purpose: Basic Science