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
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Respiratory Syncytial Virus Infections
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Prevention
Participation Requirements
- Age
- Younger than 624 years
- Gender
- Both males and females
Description
Human respiratory syncytial virus (RSV) is the most common viral cause of serious acute lower respiratory illness (LRI) in infants and children under 5 years of age worldwide. This study will evaluate the infectivity, safety, and immunogenicity of two recombinant live-attenuated RSV vaccines: RSV ?N...
Human respiratory syncytial virus (RSV) is the most common viral cause of serious acute lower respiratory illness (LRI) in infants and children under 5 years of age worldwide. This study will evaluate the infectivity, safety, and immunogenicity of two recombinant live-attenuated RSV vaccines: RSV ?NS2/?1313/I1314L and RSV 276. The vaccines will be delivered as nose drops to RSV-seronegative infants and children 6 to 24 months of age. Participants will be randomly assigned to receive a single dose of the RSV ?NS2/?1313/I1314L vaccine, the RSV 276 vaccine, or placebo at study entry (Day 0). Participants will be enrolled in the study outside of RSV season, i.e., between April 1 and October 31. All participants will remain on study until they complete the post-RSV season visit between April 1 and April 30 in the calendar year following enrollment. Participants' total study duration is between 6 and 13 months, depending on when they enroll in the study. Participants will attend several study visits throughout the study, which may include physical examinations, blood collection, nasal washes, and nasal adsorption (nasosorption) specimen collection. Participants' parents or guardians will be contacted by study staff at various times during the study to monitor participants' health.
Tracking Information
- NCT #
- NCT03422237
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Ruth A. Karron, MD Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health (JHSPH)
Get Well Soon