Safety Study of a Human Metapneumovirus Challenge Virus in Healthy Adults
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Phase 1 Inpatient Study of rHMPV-SHs, a Human Metapneumovirus Challenge Strain, Administered to Healthy Adults in Isolation|
- Frequency of challenge virus (rHMPV-SHs) infection, defined as virus shedding in respiratory secretions or serological evidence of HMPV infection [ Time Frame: Measured at baseline and on Days 1 to 9 ] [ Designated as safety issue: No ]
- rHMPV-SHs shedding, as measured by peak virus titer, mean sum of daily virus titers, and total duration of shedding [ Time Frame: Measured at baseline and on Days 1 to 9 ] [ Designated as safety issue: No ]
- Frequency and severity of respiratory illness [ Time Frame: Measured at study completion ] [ Designated as safety issue: Yes ]
- Magnitude, frequency, and duration of serum and nasal wash antibody responses induced by rHMPV-SHs [ Time Frame: Measured at baseline and on Days 28, 120, and 180 ] [ Designated as safety issue: No ]
- Correlation between virus shedding and severity of clinical illness [ Time Frame: Measured at study completion ] [ Designated as safety issue: No ]
- Cytokine and chemokine concentrations in nasal wash samples and relationships between cytokine/chemokine induction, viral replication, and illness [ Time Frame: Measured at study completion ] [ Designated as safety issue: No ]
- T-cell mediated and innate immune responses [ Time Frame: Measured at baseline and on Days 8, 28, and 180 ] [ Designated as safety issue: No ]
- Whether HMPV infection induces characteristic gene expression patterns in cells obtained from blood or nasal wash [ Time Frame: Measured at baseline and Days 3, 5, 7, 8, 28, and 180 ] [ Designated as safety issue: No ]
- Relationship between the development of immune responses and clearance of rHMPV-SHs [ Time Frame: Measured at study completion ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Experimental: HMPV challenge virus
Participants will receive the HMPV challenge virus.
Biological: HMPV challenge virus
Single dose of 10^6 plaque forming units (PFU) of recombinant HMPV small hydrophobic genes (rHMPV-SHs)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01109329
|United States, Maryland|
|Johns Hopkins Bloomberg School of Public Health|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Ruth Karron, MD||Johns Hopkins University, Bloomberg School of Public Health|