Safety of and Immune Response to a Human Parainfluenza Virus Vaccine (rHPIV3cp45) in Healthy Infants
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 and
      children.
    

Detailed description: 
      HPIV type 3 (HPIV3) ranks second only to respiratory syncytial virus as the most important
      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 recombinant attenuated intranasal HPIV3 vaccine, rHPIV3cp45.

      This study will last for a maximum of 180 days. Infants will be enrolled into one of two
      study groups, Group 1 or Group 2. Depending on the study location, groups will enroll either
      sequentially or concurrently. Within each group, infants will be randomly assigned to receive
      2 immunizations of rHPIV3cp45 or placebo. Immunizations will be given as nose drops.
      Immunizations will be given at study entry and approximately 4 to 10 weeks after study entry.

      On the day of immunization, a physical exam, vital signs measurement, blood collection, and
      medical history will occur. Infants will be observed for 15 minutes after immunization for
      any immediate adverse effects. Parents or guardians will be given a thermometer to take with
      them and will be instructed on how to take their infant's temperature. They will be given the
      study schedule and will need to provide contact phone numbers so study personnel can contact
      them by phone during the days after immunization. Parents and guardians will be contacted by
      telephone on days without study visits, from Day 1 to Day 19 and on Day 180 after
      immunization, and asked about any illnesses or adverse effects they have observed in their
      immunized infants.

      Parents or guardians will need to record their infant's temperature daily for at least the 17
      days immediately following immunization. During this 17-day period, there will be at least 6
      study visits associated with each immunization; visits will occur on the day of immunization
      and approximately 3, 7, 10, 14, and 17 days after immunization. At all study visits, infants
      will undergo a physical exam and vital signs measurement. Group 1 participants will also
      undergo a nasal wash for a viral culture. There will be additional follow-up visits occurring
      sometime between 28 and 70 days after the first dose and 28 to 35 days after the second dose;
      blood collection will occur at the follow-up visits. Additional visits may be required on
      selected days during the month after immunization. Infants who experience illness or side
      effects may be asked to return to the clinic for examination. Parents or guardians will be
      made aware of whether their infant received the HPIV vaccine or placebo 18 days after the
      second immunization or in the event of a lower respiratory tract illness.
    

Intervention name(s): rHPIV3cp45; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Placebo for rHPIV3cp45 vaccine is 1X L-15.; Placebo for rHPIV3cp45 vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Respiratory Tract Infection