NCT01805921

RSV001 - A New Vaccine to Prevent Severe Viral Chest Infections.

A Phase I Study to Assess Safety and Immunogenicity of a New Respiratory Syncytial Virus (RSV) Vaccine Based on the RSV Viral Proteins F, N and M2-1 Encoded by Simian Adenovirus (PanAd3-RSV) and Modified Vaccinia Virus Ankara (MVA-RSV)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: ReiThera Srl · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
BIOLOGICAL	PanAd3-RSV given intra-nasally (high dose)	High dose = 5x10\^10 vp
BIOLOGICAL	MVA-RSV given by intra-muscular injection (high dose)	High dose = 1x10\^8 pfu
BIOLOGICAL	PanAd3-RSV given by intra-muscular injection (high dose)	High dose = 5x10\^10 vp
BIOLOGICAL	PanAd3-RSV given intranasally (low dose)	Low dose = 5x10\^9 vp
BIOLOGICAL	MVA-RSV given by intra-muscular injection (low dose)	Low dose = 1x10\^7 pfu
BIOLOGICAL	PanAd3-RSV given by intra-muscular injection (low dose)	Low dose = 5x10\^9 vp

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2013-03-06
• Last updated: 2016-04-26

Locations

1 site across 1 country: United Kingdom