Human Metapneumovirus Clinical Trial
Official title:
Phase 1 Inpatient Study of rHMPV-SHs, a Human Metapneumovirus Challenge Strain, Administered to Healthy Adults in Isolation
Human metapneumovirus (HMPV) is a virus that can cause respiratory illness. In older adults, those with asthma, infants, and children, illness can be severe, but in healthy adults the virus frequently causes no symptoms. The National Institute of Allergy and Infectious Diseases (NIAID) is working to develop a vaccine for HMPV that could be given to infants. Before potential vaccines can be tested, information about how HMPV affects healthy adults is needed. This study will examine the effects of exposure to HMPV in healthy adults.
Human metapneumovirus (HMPV), a virus that causes respiratory illness, was first discovered
in 2001, although humans have been infected with it for at least 50 years. HMPV may cause
upper respiratory illness or no symptoms at all in healthy adults, but older adults, adults
with asthma, and children may be at risk of more serious illness. HMPV is a leading cause of
viral lower respiratory infection (LRI) in children, so finding a vaccine for this virus
could substantially reduce the instances of childhood respiratory illnesses.
The National Institute of Allergy and Infectious Diseases (NIAID) is developing a vaccine
for HMPV for use in infants, but before starting clinical trials with potential HMPV
vaccines, researchers need to study how wild HMPV affects healthy adults. This study will
expose healthy adults to a dose of the HMPV virus to assess its ability to infect, cause
disease, and create an immune system response.
Participation in this study will last approximately 6 months. Participants will be admitted
to an inpatient unit, where they will stay for 10 full days. On their second day in the
unit, participants will receive a single dose of the virus, delivered via nose drops. Twice
each day while participants are inpatients, they will undergo physical exams and have their
vital signs recorded. Nasal washes and blood samples will be collected before participants
receive the virus, and then daily nasal washes will be collected until they are discharged
from the inpatient unit. Participants will be discharged from the unit on the 9th day after
receiving virus if their nasal wash from Day 8 was free of virus. Follow-up visits will
occur 28, 120, and 180 days after participants receive the virus. During follow-up visits
nasal washes and blood samples will be collected.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Unknown status |
NCT00613184 -
Comparison of Nylon Flocked Swabs and Saline Aspirates for Detection Respiratory Viruses
|
N/A | |
Recruiting |
NCT06134648 -
Study of a Respiratory Syncytial Virus/Human Metapneumovirus Vaccine Candidate
|
Phase 1/Phase 2 | |
Recruiting |
NCT05743881 -
A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months
|
Phase 1 |