Safety of and Immune Response to Recombinant Live Attenuated Parainfluenza Type 3 Virus Vaccine in Healthy Infants and Children
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 primary 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 approximately 28 weeks. Infants and children 6 months to 36 months
      of age will be randomly assigned to one of two groups. Group 1 participants will receive 2
      immunizations of rHPIV3cp45. Group 2 participants will receive 2 doses of rHPIV3cp45 placebo.
      Immunizations will be given as nose drops and administered at study entry and approximately
      22 to 27 weeks after study entry.

      On the day of immunization, a physical exam and blood collection will occur. Participants
      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 child'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 daily from Day 1 to
      Day 18 after each immunization.

      Parents or guardians will need to record their child's temperature daily for at least 17 days
      immediately following immunization. During this 17-day period, study visits will occur on
      Days 3, 6, and 12 after each dose of vaccine or placebo. Participants will undergo a nasal
      wash for a viral culture at all study visits. There will be additional follow-up visits
      occurring sometime between 49 and 63 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.
    

Intervention name(s): rHPIV3cp45; rHPIV3cp45 placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10^5 TCID50 nasal drops; 1X-L15 nasal drops
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Respiratory Tract Infection