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 IMPAACT 2000.
    

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. 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 27), 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