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

NCT01805921 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2016-04-26

No results posted yet for this study

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.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

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

Sponsors & Collaborators

  • ReiThera Srl

    lead INDUSTRY

Principal Investigators

  • Andrew J Pollard, FRCPCH PhD · University of Oxford. Department of Paediatrics

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01805921 on ClinicalTrials.gov