Evaluating the Safety and Immunogenicity of a Human Parainfluenza Type 3 (HPIV3) Virus Vaccine in Infants and Children
Condition: Parainfluenza Virus 3, Human
MeSH terms: Paramyxoviridae Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Human parainfluenza virus type 3 (HPIV3) is a major cause of pneumonia and other respiratory
      diseases in infants and children. This study will evaluate the safety and immune response of
      an HPIV3 vaccine in infants and young children.
    

Detailed description: 
      Human parainfluenza viruses can cause serious respiratory tract disease in infants and
      children under 5 years of age, and approximately 25% of children under 5 years of age have
      experienced a clinically significant parainfluenza virus infection. HPIV3, one of the four
      types of the parainfluenza virus, can cause pneumonia, bronchiolitis, croup, and bronchitis,
      and virtually all children have experienced primary HPIV3 infections by the time they are 3
      to 4 years of age. In the United States, HPIV3 is responsible for approximately 11% of
      hospitalizations for respiratory diseases in children. Because HPIV3-associated lower
      respiratory illness typically occurs in the first year of life, the need exists for an HPIV3
      vaccine that is safe and effective in infants. The purpose of this study is to evaluate the
      safety and immunogenicity of two doses of a live attenuated HPIV3 vaccine in infants and
      young children.

      This study will enroll healthy, HPIV3 seronegative infants and children 6 months to 36 months
      of age. Participants will be randomly assigned to receive either the HPIV3 vaccine or a
      placebo vaccine. At a baseline study visit, all participants will undergo a medical history
      review, physical examination, vital sign measurements, and a nasal wash procedure. They will
      then receive their assigned vaccine in the form of nose drops. Participants will remain in
      the study clinic for 30 minutes after the vaccination for monitoring. Participants' parents
      will receive a thermometer and will record participants' temperature for 18 days after the
      vaccination. Study staff will call participants' parents on Days 1-18, 84, 112, and 140 to
      monitor participants' temperature and medical status. Study visits will occur 3, 6, 12, and
      56 days after the vaccination, and participants will undergo similar tests and procedures as
      at the vaccination visit; a blood collection will also occur at Day 56. Six months after the
      first vaccination, all participants will return to the clinic and receive the second
      vaccination. All study procedures and study visits that followed the first vaccination will
      be repeated, and participants' last follow-up visit will occur 31 days after the second
      vaccination.
    

Intervention name(s): rHPIV3cp45 Vaccine; Placebo Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 10^5 TCID^50 of rHPIV3cp45 vaccine, delivered as nose drops; Placebo vaccine, delivered as nose drops
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention