RSV Infection Clinical Trial
Official title:
A Phase I, Randomized, Observer-Blinded, Parallel-Controlled, Dose Escalation Study to Evaluate the Safety and Immunogenicity of Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell), LYB005, in Healthy Adults Aged 18 Years and Older
A phase 1, randomized, observer-blinded, parallel-controlled, dose escalation study in Australia will evaluate the safety and immunogenicity of the RSV vaccine candidate LYB005 with or without adjuvant in healthy adults aged 18 years and older.
The study design includes an age- and dose-escalation (low/middle/high dose) in two adult age groups (young adults [18-59 years] and older adults [≥60 years]). Study will be conducted in two parts, part 1 will enrolled young adults and part 2 will enroll older adults. A sentinel dosing approach will be used for close monitoring of safety to minimize risk to participants. Participants will be divided into the sentinel cohort and the remainder of cohort. Participants in part 1 will receive of one of two RSV vaccine formulations at one of 3 antigen dose levels or placebo. Participants in part 2 will receive of one of two RSV vaccine formulations at one of 3 antigen dose levels or positive control AREXVY. Detailed characterization of safety (including safety laboratory evaluation) and immune responses will be observed. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03698084 -
RESCEU: Defining the Burden of RSV Disease
|
||
| Recruiting |
NCT05550545 -
Infant RSV Infections and Health-related Quality of Life of Families
|
||
| Completed |
NCT05587478 -
A Study of EDP-323 in Healthy Subjects
|
Phase 1 | |
| Recruiting |
NCT06180993 -
Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization
|
||
| Suspended |
NCT03909867 -
Emission Patterns of Respiratory Syncytial Virus
|
||
| Recruiting |
NCT06259487 -
Coordinated Vaccination Against RSV and Influenza in Patients With Chronic Heart Failure and Its Impact on Prognosis.
|
N/A | |
| Not yet recruiting |
NCT04144816 -
Predictors of Respiratory Syncytial Virus (RSV) Hospitalizations in Infants
|
||
| Completed |
NCT01090557 -
Exhaled Nitric Oxide in Respiratory Syncytial Virus (RSV) Bronchiolitis: a Pilot Study
|
N/A | |
| Terminated |
NCT01475305 -
Intranasal Challenge of Healthy Adults With Respiratory Syncytial Virus (RSV)
|
Phase 1 | |
| Not yet recruiting |
NCT05928507 -
FINDER® Instrument and FINDER® FLU A/B, RSV, SARS-CoV-2 Test Clinical Evaluation Protocol
|
||
| Completed |
NCT03062917 -
Nasal and Bronchial Absorption Sampling in RSV Bronchiolitis
|
N/A | |
| Completed |
NCT03691623 -
A Phase 2a Study to Evaluate EDP-938 in the Virus Challenge Model
|
Phase 2 | |
| Completed |
NCT03387137 -
Evaluating the Infectivity, Safety, and Immunogenicity of a Respiratory Syncytial Virus Vaccine (RSV 6120/∆NS2/1030s) in RSV-Seropositive Children and RSV-Seronegative Infants and Children
|
Phase 1 | |
| Completed |
NCT05070975 -
Severity of RSV Infections in Twins
|
||
| Active, not recruiting |
NCT04938830 -
Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)
|
Phase 3 | |
| Recruiting |
NCT05568706 -
A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications.
|
Phase 2 | |
| Completed |
NCT03755778 -
Drug-Drug Interaction Study Between EDP-938, Itraconazole, Rifampin, and Quinidine in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01483911 -
ALX-0171 Phase I Study, Evaluating Single Ascending Dose and Multiple Dose in Healthy Male Volunteers
|
Phase 1 | |
| Recruiting |
NCT06170242 -
A Controlled Phase 2a Study to Evaluate the Efficacy of EDP-323 Against Respiratory Syncytial Virus Infection in a Virus Challenge Model
|
Phase 2 | |
| Completed |
NCT03750383 -
Drug-Drug Interaction Study Between EDP-938, Cyclosporine and Prednisone in Healthy Adult Subjects
|
Phase 1 |