Respiratory Syncytial Virus (RSV) Clinical Trial
Official title:
A RANDOMISED, PHASE 1B, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND ANTIVIRAL ACTIVITY OF RV299 AGAINST RESPIRATORY SYNCYTIAL VIRUS IN THE VIRAL CHALLENGE MODEL
The purpose of the study is to learn about the safety, pharmacokinetics and antiviral activity of the study medicine (RV299) for the potential treatment of respiratory syncytial virus (RSV). RSV is a highly contagious virus that can lead to serious lung infections in patients with reduced ability to fight infection. Most vulnerable populations include babies, the elderly and patients that have received a bone marrow transplant.
This study is seeking healthy participants who are: Healthy adult male and female participants aged between 18 to 55 years, with a total body weight ≥50 kg and body mass index (BMI) ≥18 kg/m2 and ≤35kg/m2 and who have been screened to be sero-suitable for infection with the RSV-A Memphis 37b virus challenge virus. A total of 80 participants is planned: 40 participants on RV299 and 40 participants on placebo. The study is divided into 3 phases: - Screening phase: from Day -90 to Day-3 pre-human viral challenge (HVC). - Inpatient phase: Participants will be resident in the quarantine unit for approximately 15 days (from Day -2 to Day 12). - Post RSV-A Memphis 37b virus inoculation on Day 0, participants will be randomized to receive RV299 or matched placebo. - Administration of RV299 or placebo will be twice daily (~12 hours interval) for 5 consecutive days and will start on confirmation of RSV infection. - Outpatient phase: Day 28 (±3 days) ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02593071 -
Safety and Immunogenicity of the RSV-F Vaccine in Older Adults Previously Treated With the Same Vaccine or Placebo in the Prior Year.
|
Phase 2 | |
| Completed |
NCT02266628 -
Placebo- Controlled Study to Evaluate the Safety and Immunogenicity of the RSV-F Vaccine in Elderly Adults
|
Phase 2 | |
| Completed |
NCT02282982 -
Observational Program to Assess Respiratory Syncytial Virus (RSV) Hospitalization Rate in Population of Children at High-risk of Serious RSV Illness Who Received Palivizumab Immunoprophylaxis
|
N/A | |
| Completed |
NCT01704365 -
RSV-F Vaccine Dose Ranging Study in Young Women
|
Phase 2 | |
| Completed |
NCT01709019 -
RSV-F Vaccine and Influenza Vaccine Co-Administration Study in the Elderly
|
Phase 1 | |
| Recruiting |
NCT06185647 -
Evaluation in Practice of the Impact of NIrsevimab on EmeRgency Use for BRONCHIOlitis
|
||
| Recruiting |
NCT04925310 -
Infection With Respiratory Syncytial Virus in Infants
|
||
| Completed |
NCT02968173 -
A Study to Assess the Safety and Effectiveness of Palivizumab Administered to Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infection in the Russian Federation and the Republic of Belarus
|
Phase 3 | |
| Active, not recruiting |
NCT06077149 -
Immunogenicity of RSV Vaccines in Residents of Long-Term Care Facilities (LTCF)
|
Phase 4 | |
| Completed |
NCT02608502 -
A Study to Evaluate the Efficacy of an RSV F Vaccine in Older Adults
|
Phase 3 | |
| Recruiting |
NCT05047549 -
Community-based RSV Surveillance in Infant Mortality: Minimally Invasive Tissue Sampling Study in Karachi, Pakistan
|
||
| Terminated |
NCT04225897 -
A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection.
|
Phase 2 | |
| Not yet recruiting |
NCT06392451 -
LIAISON NES Influenza (FLU) A/B, Respiratory Syncytial Virus (RSV), & Coronavirus Disease 2019 (COVID-19) in Symptomatic Patients in Australia
|
N/A | |
| Recruiting |
NCT06216093 -
Phase I, First-In Human Study to Evaluate Safety and Tolerability of EuRSV in Healthy Adults Aged Between 19 Years and 80 Years
|
Phase 1 | |
| Completed |
NCT04927793 -
Absorption, Metabolism, and Excretion (AME) Study of [14C]EDP-938 in Healthy Male Subjects
|
Phase 1 | |
| Active, not recruiting |
NCT05443607 -
Transplacental Transmission of RSV (TTRSV)
|
||
| Recruiting |
NCT04896853 -
Treatment of Respiratory Complications Associated With COVID19,Influenza ,Metapneumovirus,RSV Infection Using ProTrans®
|
Phase 1 | |
| Completed |
NCT03916185 -
Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age
|
Phase 1/Phase 2 | |
| Completed |
NCT05842967 -
A Study to Assess the Safety, Tolerability, and Immunogenicity of RSVpreF in Adults at High Risk of Severe RSV Disease
|
Phase 3 | |
| Recruiting |
NCT04909021 -
Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seronegative Children 6-36 Months
|
Phase 1 |