NCT03919591

RSV Study in Adults 60 to 75 Years of Age

An Exploratory Pilot Study to Evaluate the Clinical Safety and Virologic Profile of an Experimental RSV Infection in Adults 60 to 75 Years of Age

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Hvivo · Industry
• Sex: All
• Age: 60 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• RSV Infection

Interventions

Type	Name	Description
OTHER	Challenge virus RSV-A Memphis 37b	Each subject will receive one titre of virus, which will be up to approximately 4.5 log10 PFU.

Timeline

• Start date: 2019-03-12
• Primary completion: 2019-07-11
• Completion: 2019-07-11
• First posted: 2019-04-18
• Last updated: 2019-10-14

Locations

1 site across 1 country: United Kingdom