Safety of and Immune Response to Recombinant Live-Attenuated Parainfluenza Type 1 Virus Vaccine
Condition: Parainfluenza; Virus Diseases
MeSH terms: Virus Diseases; Paramyxoviridae Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Human Parainfluenza Virus Type 1 (HPIV1) is a leading cause of viral respiratory infections
      in children, the elderly, and those with compromised immune systems. HPIV1 is also the
      leading cause of viral croup in children under 6 years old. The purpose of this study is to
      determine the safety of and immune response to a HPIV1 vaccine, rHPIVI1 84/del170/942A, in 2
      groups of adults and then in children who have been previously exposed to HPIV1. Once the
      safety of this vaccine has been established in these groups, an additional 2 groups of
      infants and children who have not been previously exposed to HPIV1 will be vaccinated. Naïve
      infants and children are the most vulnerable to naturally circulating HPIV1 and are the
      target population of this vaccine.
    

Detailed description: 
      HPIV1 infection can result in severe respiratory illness that often leads to the
      hospitalization of infants and young children. HPIV1 is responsible for approximately 6% of
      all pediatric hospitalizations for respiratory tract diseases and is a main cause of severe
      lower respiratory tract diseases, including pneumonia and bronchiolitis in children less than
      6 years old. The purpose of this study is to determine the safety of and immune response to a
      HPIV1 vaccine, rHPIVI1 84/del170/942A, in 5 main volunteer group: first in adults (group 1
      and 2), and then in seropositive children (group 3). The last 2 groups will be seronegative
      infants and children that are split into 2 dosing groups; one group of seronegative infants
      and children will receive a lower dose of vaccine (group 4) and a second group of
      seronegative infants and children (group 5) will receive a higher dose of vaccine. This study
      will last approximately 8 weeks per group. Additional information about each of the groups is
      as follows:

      Groups 1 and 2 will consist of 35 adults total, 18 to 49 years of age. These groups will
      receive one immunization with rHPIV1 84/del170/942A at study entry. Immunization will be
      given as nose drops. Study visits will occur on Days 3, 4, 5, 6, 7, 10, and 28. Medical
      history, vital signs, clinical assessment, and nasal wash will occur at most visits. Blood
      and urine tests will occur at selected visits. A urine pregnancy test will occur for females
      at study entry. Follow-up phone reports will also be required on Day 56.

      Enrollment into Group 3 will begin only after safety data from Groups 1 and 2 are evaluated.
      Group 3 will consist of 15 seropositive children, 15 to 59 months of age. This group will
      receive either one immunization of rHPIV1 84/del170/942A or placebo at study entry.
      Immunization will be given as nose drops. Study visits will occur on Days 3, 4, 5, 6, 7, 10,
      and 28. Medical history, vital signs, clinical assessment, and nasal wash will occur at most
      visits. Blood and urine tests will occur at selected visits. Parents will be required to
      submit reports over the phone throughout the study. These reports will include the temporal
      temperature from the previous day.

      Enrollment into Group 4 will begin only after safety data from Group 3 are evaluated. Group 4
      will consist of 21-30 seronegative infants and children, 6 to 59 months of age. This group
      will receive either one immunization of rHPIV1 84/del170/942A or placebo at study entry.
      Immunization will be given as nose drops. Study visits will occur on Days 3, 5, 7, 10, 12,
      14, 17, 19, 21, 28, and 56. Medical history, vital signs, clinical assessment, and nasal wash
      will occur at most visits. Blood tests will occur at selected visits. Parents will be
      required to submit reports over the phone throughout the study. These reports will include
      the temporal temperature from the previous day.

      Enrollment into Group 5 will begin only after safety data from Group 4 are evaluated. Group 5
      will consist of 21-30 seronegative infants and children 6 to 59 months of age. This group
      will receive either one immunization of rHPIV1 84/del170/942A or placebo at study entry. The
      immunization will be given as nose drops. The vaccine dosage that participants receive in
      Group 5 will be greater than the dose in Group 4. Study visits will occur on Days 3, 5, 7,
      10, 12, 14, 17, 19, 21, 28, and 56. Medical history, vital signs, clinical assessment, and
      nasal wash will occur at most visits. Blood tests will occur at selected visits. Parents will
      be required to submit reports over the phone throughout the study. These reports will include
      the temporal temperature from the previous day.
    

Intervention name(s): rHPIV1 84/del170/942A, Lot PIV1 #104A vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Live attenuated Human Parainfluenza Type 1 Virus Vaccine; Placebo for rHPIVI1 84/del170/942A, Lot PIV1 #104A vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention