Respiratory Syncytial Virus Clinical Trial
Official title:
Characterization of the Immune Response and Viral Shedding to Experimental Infection With Respiratory Syncytial Virus, Strain A-2, in Healthy Adults Ages 21 to 40 Years Old
The purpose of this study is to measure the immune response (how the body fights infection) to an experimental preparation of live Respiratory Syncytial Virus (RSV). A better understanding of this virus may be useful in development of vaccines and treatments. Participants will include 20 healthy adults age 21-40. Study procedures will include drawing blood, urine samples, respiratory exams, vital signs and temperature, diary cards, nasal mucus weight and nasal washes and swabs. All participants will receive vaccine via nose drops. Patients will participate in the study for about 2 months.
Respiratory infections are a major cause of morbidity and mortality in the elderly. Recently, respiratory syncytial virus (RSV) has been shown to account for a significant portion of these illnesses. The causative factors associated with severe RSV disease in the elderly are not well understood. The contribution of viral load, host inflammatory responses and the cellular immune response to disease pathogenesis are unknown. A better understanding of these processes may be useful in the development of vaccines and therapeutics for RSV disease. Although the adult groups at highest risk for serious RSV disease are elderly and high-risk adults, we propose to use the challenge model in young healthy adults to determine optimal timing of specimen collection and the feasibility of performing certain tests before moving ahead to the target groups with natural infection. The purpose of this study is to measure the immune response (how the body fights infection) to an experimental preparation of live Respiratory Syncytial Virus (RSV. Participants will include 20 healthy adults age 21-40. Study procedures will include drawing blood, urine samples, respiratory exams, vital signs and temperature, diary cards, nasal mucus weight and nasal washes and swabs. All participants will receive vaccine via nose drops. Patients will participate in the study for about 2 months. ;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04528719 -
A Dose Escalation Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1345 in Healthy Adults and in Children Who Are Respiratory Syncytial Virus (RSV)-Seropositive
|
Phase 1 | |
Terminated |
NCT02508194 -
A Study to Evaluate the Efficacy of MEDI7510 in Older Adults
|
Phase 2 | |
Active, not recruiting |
NCT06060457 -
A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age
|
Phase 3 | |
Terminated |
NCT01757496 -
Cough Assist in Bronchiolitis
|
N/A | |
Completed |
NCT03524118 -
Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT05572658 -
Moderna Vaccine mRNA-1345 Observational Respiratory Syncytial Virus (RSV) Study
|
||
Recruiting |
NCT06067230 -
A Study to Investigate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in High-risk Adults
|
Phase 3 | |
Completed |
NCT00246480 -
RSV Disease in the Elderly
|
||
Active, not recruiting |
NCT06097299 -
A Study of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus
|
Phase 2 | |
Completed |
NCT00889070 -
Respiratory Events Among Premature Infants
|
N/A | |
Unknown status |
NCT00613184 -
Comparison of Nylon Flocked Swabs and Saline Aspirates for Detection Respiratory Viruses
|
N/A | |
Completed |
NCT05559905 -
Respiratory Syncytial Virus (RSV) Human Challenge Study of Molnupiravir in Healthy Participants (MK-4482-017)
|
Phase 2 | |
Active, not recruiting |
NCT05127434 -
A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age
|
Phase 2/Phase 3 | |
Terminated |
NCT04978337 -
A Study of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection
|
Phase 2 | |
Recruiting |
NCT06143046 -
A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated Mothers
|
Phase 2 | |
Active, not recruiting |
NCT05397223 -
A Study of Modified mRNA Vaccines in Healthy Adults
|
Phase 1 | |
Completed |
NCT02472548 -
A Study to Evaluate the Safety and Reactogenicity of DPX-RSV(A), a Respiratory Syncytial Virus Vaccine
|
Phase 1 | |
Completed |
NCT01562938 -
MEDI-557 Adult Dosing
|
Phase 1 | |
Completed |
NCT01734668 -
Sofia RSV FIA Field Study
|
N/A | |
Recruiting |
NCT06325657 -
A Study to Learn About the Vaccine RSVpreF In Pregnant Participants With HIV and Their Infants
|
Phase 3 |