Evaluation of the Safety and Immunogenicity of a Live Attenuated Human Metapneumovirus Vaccine
Condition: Metapneumovirus
Study type: Interventional
Phase: Phase 1

Summary: 
      People who are infected with human metapneumovirus (HMPV) may develop upper and lower
      respiratory illnesses. Children are particularly sensitive to HMPV infection. This study will
      evaluate the safety and immune response of an HMPV vaccine in healthy adults,
      HMPV-seropositive children, and HMPV-seronegative infants and children.
    

Detailed description: 
      HMPV is a viral respiratory pathogen that was discovered in 2001, but studies have shown that
      it has been circulating in humans for at least 50 years. Older adults and adults with asthma
      who are infected with HMPV may be at increased risk for lower respiratory illness and
      hospitalization. In infants and young children, HMPV infection may cause upper or lower
      respiratory illness, ear infections, bronchiolitis, croup, pneumonia, and exacerbations of
      asthma. Children less than 2 years of age are most susceptible to severe HMPV infections, and
      HMPV is the second or third leading cause of viral lower respiratory illness in children. The
      National Institute of Allergy and Infectious Diseases (NIAID) is working to develop a
      live-attenuated, intranasally administered HMPV vaccine for use in infants. The purpose of
      this study is to evaluate the safety and immunogenicity of an HMPV vaccine.

      The vaccine will be evaluated in four groups of participants: healthy adults;
      HMPV-seropositive children; and two groups of HMPV-seronegative infants and children, with
      each seronegative group receiving a different dose of the vaccine. In the adult group,
      participants will all receive the vaccine; in the infant and children groups, participants
      will be randomly assigned to receive either the vaccine or a placebo. Study researchers will
      review participants' study data and confirm the safety of the vaccine before enrolling the
      next group of participants.

      This study will first enroll healthy adults. At a baseline study visit, all participants will
      undergo a medical history review, physical examination, nasal wash procedure, vital sign
      measurements, and a blood collection. They will then receive the vaccine, and they will
      remain in the clinic for 30 minutes for observation. Participants will record their
      temperature daily for 12 days. Additional study visits will occur at Days 3, 4, 5, 6, 7, 10,
      and 12. At each study visit, participants will undergo a medical history review, vital sign
      measurements, and a nasal wash procedure. A final study visit will occur on Day 28 and will
      also include a blood collection. The second group of participants will include seropositive
      children. They will receive the vaccine or a placebo vaccine and take part in the same study
      procedures as the adult participants. Participants' parents will receive telephone calls or
      e-mails from study staff on Days 1, 2, 8, 9, 11, and 13 to obtain and record medical history
      and temperature readings. The third and fourth groups of participants will include
      seronegative infants and children. Each of these two groups will receive different doses of
      the vaccine or placebo vaccine. They will attend study visits on Days 3, 5, 7, 10, 12, 14,
      17, 19, 21, 28, and 56, and they will undergo the same study procedures as the other
      participants. Parents of seronegative infants and children will receive telephone calls or
      e-mails from study staff on Days 1, 2, 4, 6, 8, 9, 11, 13, 15, 16, 18, 20, 22 to 27, and 29.

      Study staff will call all participants at Month 6 for a medical history review and follow up.
    

Intervention name(s): 10^6 PFU rHMPV-Pa vaccine; 10^5 PFU rHMPV-Pa vaccine; Placebo Vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Single dose of 10^6 PFU rHMPV-Pa vaccine delivered intranasally; Single dose of 10^5 PFU rHMPV-Pa vaccine delivered intranasally; Single dose of placebo vaccine delivered intranasally
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention