Safety of and Immune Response to a Cow/Human Parainfluenza Virus Vaccine (rB/HPIV3) in Healthy Infants, Children, and Adults
Condition: Paramyxoviridae Infections; Virus Diseases
MeSH terms: Virus Diseases; Paramyxoviridae Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Human parainfluenza viruses (HPIVs) are a major health concern in infants and young children
      under 5 years of age, causing serious respiratory tract disease. The purpose of this study is
      to test the safety of and immune response to a new HPIV vaccine in healthy infants, children,
      and adults.
    

Detailed description: 
      HPIV type 3 (HPIV3) ranks second only to respiratory syncytial virus as the most common cause
      of bronchiolitis and pneumonia in infants less than 6 months of age. HPIV3 can cause severe
      disease in the first 2 years of life and is responsible for 11% of hospitalizations for
      respiratory diseases in children. This study will evaluate the safety and immunogenicity of a
      live, chimeric bovine/human, attenuated intranasal HPIV3 vaccine, rB/HPIV3. This vaccine
      combines modified human HPIV3 with a related, modified cow virus, bovine parainfluenza type 3
      virus (BPIV3). Vaccinations will be given as nose drops to healthy adults, children
      seropositive for HPIV3, and infants and children seronegative for HPIV3.

      There are four groups in this study. Group 1 will consist of adults who will receive the
      higher dose of rB/HPIV3. Group 2 will consist of seropositive children who will be randomly
      assigned to receive the higher dose of rB/HPIV3 or placebo. Group 2 will not begin enrollment
      until the completion of Group 1 safety data review. Participants of both Groups 1 and 2 will
      be monitored for 10 days post vaccination for respiratory illness and for fever by
      self-reported temperature logs; these participants will be followed for a maximum of 28 days.
      Blood collection will occur at study entry and on Day 28; additional blood collection may
      occur up to 28 days prior to vaccination. Clinical assessments and nasal washes will occur at
      study entry and selected study visits. Group 1 participants will be contacted by phone on Day
      180; Group 2 participants' parents or guardians will be contacted by phone on Days 1, 2, 8,
      9, 11, and 180; study staff will ask about any illnesses or adverse events that may have
      occurred.

      Groups 3 and 4 will consist of seronegative infants and children. Group 3 will not begin
      enrollment until the completion of Group 2 safety data review. Children in Group 3 will be
      randomly assigned to receive the lower dose of rB/HPIV3 or placebo. Group 4 will not begin
      enrollment until the completion of Group 3 safety data review. Children in Group 4 will be
      randomly assigned to receive the higher dose of rB/HPIV3 or placebo. Participants of both
      Groups 3 and 4 will be monitored closely for 28 days postvaccination for respiratory illness
      and for fever by self-reported temperature logs; these participants will be followed for a
      maximum of 56 days. Blood collection will occur at study entry and on Day 56. Clinical
      assessments and nasal washes will occur at study entry and most study visits. Participants'
      parents or guardians will be contacted by phone periodically post vaccination; study staff
      will ask about any illnesses or adverse events they may have observed in their infants or
      children.
    

Intervention name(s): rB/HPIV3; rB/HPIV3; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Live attenuated rB/HPIV3 vaccine given at a dose of 10^6 TCID50; Live attenuated rB/HPIV3 vaccine given at a dose of 10^5 TCID50; Placebo for rB/HPIV3 vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Respiratory Tract Disease; Bovine; Chimeric Vaccine