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28 active trials for Respiratory Syncytial Virus Infections

Study of the Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seropositive Children

This study evaluates an investigational vaccine that is designed to protect humans against infection with respiratory syncytial virus (RSV) and is administered as drops in the nose. Specifically, the study analyzes the safety of, and the immune response to, the vaccine when administered to healthy children between the ages of 15 and 59 months who are seropositive to RSV.

Start: June 2020

RESCEU: Defining the Burden of RSV Disease

This observational study will determine the burden of RSV disease in at least 2000 healthy infants over 3 years from September 2017 to September 2020. The study will determine the incidence of acute respiratory tract infection (ARTI) associated with RSV, of medically attended ARTI and RSV related hospitalisation. Mortality (RSV associated and all-cause) through all RSV seasons and the health care costs, resource use and Health Related Quality of Life will also be determined. The study also aims to determine important risk factors for RSV infection (by severity and healthcare utilisation.

Start: September 2017

Evaluation of a Single Use Point of Care Device for the Diagnosis of Respiratory Pathogens

This study evaluates a single use point of care diagnostic test in the diagnosis of influenza and other respiratory viral infections in adults. Participants will have a sample taken from their nose using a swab. The swab will be gently mixed in a liquid solution which will then be transferred into the device for testing.

Start: February 2020

Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in Infants and Children

Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants and children around the world. This study will evaluate the safety and immune response to a RSV vaccine in three groups of participants: healthy children who have already had an RSV infection (RSV seropositive), healthy infants and children who have not already had an RSV infection (RSV seronegative), and healthy younger infants who have not been screened for prior RSV infection.

Start: June 2013

Evaluating the Infectivity, Safety, and Immunogenicity of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ?NS2/?1313/I1314L or RSV 276 in RSV-Seronegative Infants and Children 6 to 24 Months of Age

The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines RSV ?NS2/?1313/I1314L or RSV 276 or placebo when delivered as nose drops to RSV-seronegative infants and children 6 to 24 months of age. This study is a companion study to IMPAACT 2018.

Start: October 2017

Inpatient Challenge Study of rRSV A/Maryland/001/11, a Human Respiratory Syncytial Virus Challenge Strain, Administered to Healthy Adult Volunteers

The purpose of this study is to evaluate the safety, infectivity and replication, and immunogenicity of a recombinant respiratory syncytial virus (rRSV A/Maryland/001/11) challenge virus administered intranasally to healthy adults.

Start: July 2018

Predictors of Respiratory Syncytial Virus (RSV) Hospitalizations in Infants

The VRS (Respiratory Syncytial Virus) study group in Lyon is a working that aims to understand, predict and prevent the burden of disease caused by human respiratory syncytial virus (RSV) infection in infants. Incidence of RSV-associated hospitalization in the first year of life was estimated at 14.5 (95% CI 13.4-15.6) per 1000 births in a cohort study in Lyon, France. Related direct medical annual costs were estimated for this cohort at 364,269€, mostly attributed to children born during the RSV season (231,959€) and children born premature (108,673€). This study will combine existing hospital specimens and databases to determine the respective role of socio demographic factors, clinical risk factors, level of cord specific antibody at birth, and virus characteristic in the Respiratory Syncytial Virus (RSV) Hospitalization outcome in Infants. Regarding the introduction of a new RSV vaccine and RSV-specific neutralizing antibodies, these data are of prime importance to guide future vaccine policies.

Start: October 2019

RESCEU Study, Defining the Burden of Disease of RSV in Older Adults

The REspiratory Syncytial virus Consortium in EUrope (RESCEU) is an Innovative Medicine Initiative (IMI) funded by the EU under the H2020 framework to define and understand the burden of disease caused by human respiratory syncytial virus (RSV) infection. RSV causes severe disease in individuals at the extremes of the age spectrum and in high risk groups. It was estimated that RSV was associated with 34 million cases of acute respiratory tract infection (ARTI), 3.4 million ARTI hospitalizations and 55,000 to 199,000 deaths in children <5 years in 2005 worldwide. The estimated burden of disease in older adults is comparable with non-pandemic influenza A (for which a vaccine is available). These estimates were based on limited data and there is a substantial gap in knowledge on morbidity and associated healthcare and social costs in Europe. New vaccines and therapeutics against RSV are in development and could soon be available on the European market. RESCEU will deliver knowledge of the incidence and burden of RSV disease in young children and older adults in Europe, which is essential for stakeholders (governments, etc.) to take decisions about prophylaxis and treatment. Objective: To determine the burden of disease due to RSV in older adults. Study design: Prospective epidemiological, observational, multi-country, multicenter cohort study. Study population: Adults aged 60 years and up (n=1,000) of which approximately 50% is above 75 years of age. Main study parameters/endpoints: The primary endpoints of the study are; The incidence of RSV infection-associated ARTI. RSV associated medically attended (MA) ARTI. RSV related hospitalization.

Start: August 2017