Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants
      and children. This study will evaluate the safety and immune response to an RSV vaccine in
      healthy RSV-naïve children.
    

Detailed description: 
      RSV is the most common viral cause of serious acute lower respiratory illness (LRI) in
      infants and children under 5 years of age around the world. RSV illness can range from mild
      upper respiratory tract illness (URI) to severe LRI, including bronchiolitis and pneumonia.
      This study will evaluate the safety and immunogenicity of an RSV vaccine in healthy RSV-naïve
      children.

      At study entry, participants will undergo a medical history review, physical examination,
      blood collection, and a nasal wash. Participants will be randomly assigned to receive the RSV
      vaccine or placebo at a 2:1 ratio, to be administered as nose drops. Subjects will be
      actively monitored for 28 days following administration of vaccine or placebo; monitoring
      will include medical history reviews, clinical assessments, and at some visits, nasal washes.
      On the days when no study visit is scheduled, study researchers will contact participants'
      parents or guardians for medical follow-up. At a study visit on Day 56, participants will
      undergo a medical history review, blood collection, and a nasal wash procedure.

      From November through March following each subject's study participation, parents or
      guardians will report respiratory and/or febrile illnesses on a weekly basis via telephone
      calls to study researchers. Participants may have additional study visits that may include
      blood collection and/or nasal wash procedures during this follow-up period.

      This protocol is a companion study to P1114; a study being conducted by the Center for
      Immunization Research (CIR, Johns Hopkins, Baltimore), and the Laboratory of Infectious
      Diseases (NIAID, Bethesda). The protocols have identical primary and secondary objectives;
      immunization schedules; evaluation assays and schedules; safety monitoring and reporting. The
      protocols will vary slightly in site selection requirements, eligibility requirements and
      site monitoring. These are all operational issues modified to account for the IMPAACT sites'
      operations and infrastructure.
    

Intervention name(s): RSV cps2 Vaccine; Placebo Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 10^5.3 plaque forming units (PFUs) of RSV cps2 vaccine will be administered as nose drops (0.25 mL per nostril, for a total of 0.5 mL).; Placebo vaccine will be administered as nose drops (0.25 mL per nostril, for a total of 0.5 mL).
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention