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AzTrials

Human MetapneumovirusPhase 1NCT01109329

Safety Study of a Human Metapneumovirus Challenge Virus in Healthy Adults

A Phase 1 study testing HMPV challenge virus in people with Human Metapneumovirus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Human Metapneumovirus
What is being tested?
HMPV challenge virus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
Jun 2010to Dec 2010
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator
  • Available for the duration of the trial
  • Female subjects must agree to use effective birth control methods for the duration of the study

Who cannot join

  • Pregnant
  • Currently breastfeeding
  • Evidence of clinically significant diseases in the nervous system, heart, lungs, liver, autoimmune system, or kidney or involving rheumatism, as determined by medical history, physical examination, or laboratory studies, including urine testing.
  • Clinically significant alanine aminotransferase (ALT) levels, as determined by the principal investigator (PI)
  • Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, affects the ability to understand and cooperate with the study protocol
  • Human metapneumovirus (HMPV) specific serum immunoglobulin A (IgA) titer greater than 1:50
Show all 25Show fewer
  • HMPV-specific nasal wash IgA titer greater than 1:50
  • Positive urine drug toxicology test indicating narcotic use
  • Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
  • Other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol
  • History of hypersensitivity reactions
  • Diagnosis of asthma or reactive airway disease within the past 2 years
  • Positive result on test for HIV
  • Positive result on test for hepatitis C virus (HCV)
  • Positive result on test for hepatitis B virus surface antigen (HBsAg)
  • Known immunodeficiency syndrome
  • Use of corticosteroids (excluding topical or nasal preparations) or immunosuppressive drugs within 30 days prior to inoculation
  • Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to inoculation with challenge virus, rHMPV-SHs
  • History of a surgical removal of the spleen
  • Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study inoculation
  • Current smoker unwilling to stop smoking for the duration of the study
  • Receipt of another investigational vaccine or drug within 30 days prior to study inoculation
  • Body mass index (BMI) greater than 35
  • Shares household with a child younger than 60 months of age or an immunocompromised individual
  • Unwillingness to have nasal wash or blood samples saved for future respiratory virus research

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins Bloomberg School of Public Health

    Baltimore, Maryland, 21205

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
HMPV challenge virus
Keywords
Vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HMPV challenge virusBiological

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

Study groups in NCT01109329
Study groupRoleWhat they receive
HMPV challenge virusExperimentalParticipants will receive the HMPV challenge virus.
Receives: Biological: HMPV challenge virus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of challenge virus (rHMPV-SHs) infection, defined as virus shedding in respiratory secretions or serological evidence of HMPV infection

    Measured: Measured at baseline and on Days 1 to 9

  2. rHMPV-SHs shedding, as measured by peak virus titer, mean sum of daily virus titers, and total duration of shedding

    Measured: Measured at baseline and on Days 1 to 9

  3. Frequency and severity of respiratory illness

    Measured: Measured at study completion

Secondary outcomes (6)

  1. Magnitude, frequency, and duration of serum and nasal wash antibody responses induced by rHMPV-SHs

    Measured: Measured at baseline and on Days 28, 120, and 180

  2. Correlation between virus shedding and severity of clinical illness

    Measured: Measured at study completion

  3. Cytokine and chemokine concentrations in nasal wash samples and relationships between cytokine/chemokine induction, viral replication, and illness

    Measured: Measured at study completion

  4. T-cell mediated and innate immune responses

    Measured: Measured at baseline and on Days 8, 28, and 180

  5. Whether HMPV infection induces characteristic gene expression patterns in cells obtained from blood or nasal wash

    Measured: Measured at baseline and Days 3, 5, 7, 8, 28, and 180

  6. Relationship between the development of immune responses and clearance of rHMPV-SHs

    Measured: Measured at study completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionDec 2010
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01109329
Sponsor's protocol ID
CIR 270
Status last verified
Dec 2012
First submitted
21 Apr 2010
Last updated
3 Jan 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19845113

  • 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. doi: 10.1056/NEJMoa025472.

    PubMed 14749452

  • Talaat KR, Luke CJ, Khurana S, Manischewitz J, King LR, McMahon BA, Karron RA, Lewis KD, Qin J, Follmann DA, Golding H, Neuzil KM, Subbarao K. A live attenuated influenza A(H5N1) vaccine induces long-term immunity in the absence of a primary antibody response. J Infect Dis. 2014 Jun 15;209(12):1860-9. doi: 10.1093/infdis/jiu123. Epub 2014 Mar 5.

    PubMed 24604819

  • Talaat KR, Karron RA, Thumar B, McMahon BA, Schmidt AC, Collins PL, Buchholz UJ. Experimental infection of adults with recombinant wild-type human metapneumovirus. J Infect Dis. 2013 Nov 15;208(10):1669-78. doi: 10.1093/infdis/jit356. Epub 2013 Aug 1.

    PubMed 23908489

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HMPV challenge virus in people with Human Metapneumovirus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01109329, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2013.

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