Safety and Immune Response to a Live-Attenuated 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: 
      Respiratory syncytial virus (RSV) is a common cause of illness in infants and children around
      the world. This study will evaluate the safety and immune response to an RSV vaccine in
      RSV-seronegative infants and children.

      This study is a companion study to CIR 291.
    

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 in the world. RSV illness can range from mild upper
      respiratory tract illness (URI) to severe LRI, including bronchiolitis and pneumonia. Severe
      RSV disease in infancy may also predispose children to develop reactive airway disease during
      childhood. The purpose of this study is to evaluate the safety and immunogenicity of an RSV
      vaccine (RSV LID ΔM2-2) in RSV-seronegative infants and children at least 6 months and
      through 24 months of age.

      To determine study eligibility, the screening process will include a blood collection.
      Screening may begin after the RSV season (i.e., as of April 1) and enrollment must precede
      the RSV season (no later than October 14). At study entry, eligible participants will be
      randomly assigned to receive one dose of either the RSV vaccine or placebo, which will be
      delivered as nose drops. Participants will also undergo a review of medical history, clinical
      assessment, and a nasal wash. They will then receive their assigned vaccine and will remain
      under observation for monitoring for 30 minutes after receiving the vaccine. Additional study
      visits will occur at Days 3, 5, 7, 10, 12, 14, 17, 19, 21, 28, and 56. These visits will
      include clinical assessments and nasal washes; on Day 56, a blood collection will also occur.
      On days where no study visit is scheduled (through Day 29), participants' parents or
      guardians will report participants' temperatures and signs of illness to researchers by
      e-mail or phone.

      In October following vaccination, participants may have a pre-RSV season blood collection
      visit. During RSV season, November through March following vaccination, researchers will
      contact participants' parents or guardians on a weekly basis for follow-up monitoring. During
      this time frame, participants seen by a medical provider for fever, respiratory illness, or
      otitis media will have a study visit, which will include a nasal wash and clinical
      assessment. In April following vaccination, participants will undergo a final blood
      collection.
    

Intervention name(s): RSV LID ΔM2-2 Vaccine; Placebo Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 10^5.0 plaque forming units (PFU); 0.5 mL dose delivered as nose drops (approximately 0.25 mL per nostril); 0.5 mL dose delivered as nose drops (approximately 0.25 mL per nostril)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention