Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01109329
Other study ID # CIR 270
Secondary ID
Status Completed
Phase Phase 1
First received April 21, 2010
Last updated December 31, 2012
Start date June 2010
Est. completion date December 2010

Study information

Verified date December 2012
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Description:

Read more »
Read more »

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
HMPV challenge virus
Single dose of 10^6 plaque forming units (PFU) of recombinant HMPV small hydrophobic genes (rHMPV-SHs)

Locations

Country Name City State
United States Johns Hopkins Bloomberg School of Public Health Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Bruno R, Marsico S, Minini C, Apostoli P, Fiorentini S, Caruso A. Human metapneumovirus infection in a cohort of young asymptomatic subjects. New Microbiol. 2009 Jul;32(3):297-301. — View Citation

Williams JV, Harris PA, Tollefson SJ, Halburnt-Rush LL, Pingsterhaus JM, Edwards KM, Wright PF, Crowe JE Jr. Human metapneumovirus and lower respiratory tract disease in otherwise healthy infants and children. N Engl J Med. 2004 Jan 29;350(5):443-50. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of challenge virus (rHMPV-SHs) infection, defined as virus shedding in respiratory secretions or serological evidence of HMPV infection Measured at baseline and on Days 1 to 9 No
Primary rHMPV-SHs shedding, as measured by peak virus titer, mean sum of daily virus titers, and total duration of shedding Measured at baseline and on Days 1 to 9 No
Primary Frequency and severity of respiratory illness Measured at study completion Yes
Secondary Magnitude, frequency, and duration of serum and nasal wash antibody responses induced by rHMPV-SHs Measured at baseline and on Days 28, 120, and 180 No
Secondary Correlation between virus shedding and severity of clinical illness Measured at study completion No
Secondary Cytokine and chemokine concentrations in nasal wash samples and relationships between cytokine/chemokine induction, viral replication, and illness Measured at study completion No
Secondary T-cell mediated and innate immune responses Measured at baseline and on Days 8, 28, and 180 No
Secondary Whether HMPV infection induces characteristic gene expression patterns in cells obtained from blood or nasal wash Measured at baseline and Days 3, 5, 7, 8, 28, and 180 No
Secondary Relationship between the development of immune responses and clearance of rHMPV-SHs Measured at study completion No
See also
  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