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MetapneumovirusPhase 1NCT01255410

Evaluation of the Safety and Immunogenicity of a Live Attenuated Human Metapneumovirus Vaccine

A Phase 1 study testing 10^6 PFU rHMPV-Pa vaccine and 10^5 PFU rHMPV-Pa vaccine in people with Metapneumovirus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites 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

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… Read more about this study

Who is it for?
Ages 6 months to 49 yearsHealthy volunteers can take part
Conditions the study is for
Metapneumovirus
What is being tested?
10^6 PFU rHMPV-Pa vaccine and 10^5 PFU rHMPV-Pa vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
2 sitesUnited States
Study dates
Jan 2011to Jan 2015
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 6 months to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Adult males and non-pregnant, non-nursing females 18 to 49 years old
  • In good health without significant medical illness, physical examination findings, or significant laboratory abnormalities in urinalysis, complete blood count (CBC), alanine aminotransferase (ALT), or creatinine as determined by the investigator
  • Available for the duration of the study
  • Willing to participate in the study as evidenced by signing the informed consent document
  • Female participants of childbearing potential must have negative urine pregnancy tests and must agree to use effective birth control methods (e.g., birth control pills, diaphragm and foam, condoms with spermicide, Depo-Provera) until 28 days after vaccination
  • Healthy children 12 to 59 months of age, whose parent/guardian understands and signs the informed consent and who agrees to vaccine administration following a detailed explanation of the study
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  • Seropositive for HMPV as defined by serum neutralizing antibody titer greater than or equal to 1:40. If a child between 12 and 59 months of age is determined to be HMPV seropositive prior to Day 56, s/he does not need an additional screening serum specimen, but a prevaccination serum specimen must be obtained.
  • Participant's history has been reviewed and they have undergone a physical examination indicating that s/he is in good health
  • Available for the duration of the study
  • Healthy children 6 to 59 months of age whose parents/guardians can understand and sign the informed consent and who agree to vaccine administration following detailed explanation of the study
  • Seronegative for HMPV antibody as defined by serum neutralizing antibody titer less than 1:40 as determined within 42 days prior to inoculation
  • Participant's history has been reviewed and they have undergone a physical examination indicating that s/he is in good health
  • Available for the duration of the study

Who cannot join

  • Pregnant, as determined by a positive urine beta-human chorionic gonadotropin (HCG) test
  • Breastfeeding
  • Females of childbearing potential who are unwilling to practice effective birth control as described in the inclusion criteria
  • Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urinalysis
  • Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the participant to understand and cooperate with the study protocol
  • Other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a participant in the study or would render the participant unable to comply with the protocol
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  • Has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the 12 months before study entry
  • History of a severe allergic reaction or anaphylaxis
  • History of splenectomy
  • Current diagnosis of asthma in the 2 years prior to study entry
  • Positive enzyme-linked immunosorbent assay (ELISA) and confirmatory Western blot tests for HIV-1
  • Positive ELISA and confirmatory immunoblot tests for hepatitis C (HCV)
  • Positive ELISA HBsAg
  • Abnormal urinalysis/urine dip
  • Known immunodeficiency syndrome
  • Current use of nasal or systemic steroid medications
  • Receipt of blood products (including immunoglobulin) in the 3 months before study entry
  • Current smoker unwilling to stop smoking for the duration of the study. More information on this criterion can be found in the protocol.
  • Receipt of another investigational vaccine or investigational drug within 28 days of receiving this investigational HMPV vaccine
  • Receipt of a live vaccine in the 4 weeks before study entry, a killed vaccine in the 2 weeks before study entry, or immune globulin within the 3 months prior to receiving the investigational vaccine
  • Previous enrollment in an HMPV vaccine or viral challenge study
  • Known hypersensitivity to any vaccine component
  • Adults whose professional and/or personal responsibilities involve caring for children less than 59 months of age or for immunosuppressed individuals
  • Systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
  • Body mass index (BMI) greater than 35
  • Known or suspected impairment of immunological functions, including maternal history of positive HIV test, receiving immunosuppressive therapy including systemic corticosteroids, or bone marrow/solid organ transplant recipients (topical steroids, topical antibiotics, and topical antifungal medications are acceptable)
  • Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
  • Previous immunization with an HMPV vaccine
  • Current use of nasal or systemic steroid medications
  • Previous serious vaccine-associated adverse event or anaphylactic reaction
  • Known hypersensitivity to any vaccine component
  • Lung or heart disease, including any wheezing event or reactive airway disease. People with clinically insignificant cardiac abnormalities requiring no treatment may be enrolled. People who wheezed once or received bronchodilator therapy once in the first year of life but who have not had any additional wheezing episodes or bronchodilator therapy for at least 12 months before study entry may also be enrolled.
  • Member of a household that includes an immunocompromised individual or infants less than 12 months of age, other than a study participant
  • Attends day care with infants less than 12 months of age, or immunosuppressed individuals, and whose parent/guardian is unable or unwilling to suspend daycare for 14 days following immunization. Children who attend facilities that separate children by age and minimize opportunities for transmission of virus through direct physical or aerosol contact are acceptable.
  • Receipt of another investigational vaccine or investigational drug within 28 days of receiving this investigational HMPV vaccine
  • Known or suspected impairment of immunological functions, including maternal history of positive HIV test, receiving immunosuppressive therapy including systemic corticosteroids, or bone marrow/solid organ transplant recipients (topical steroids, topical antibiotics, and topical antifungal medications are acceptable)
  • Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
  • Previous immunization with an HMPV vaccine
  • Current use of nasal or systemic steroid medications
  • Previous serious vaccine-associated adverse event or anaphylactic reaction
  • Known hypersensitivity to any vaccine component
  • Lung or heart disease, including any wheezing event or reactive airway disease. People with clinically insignificant cardiac abnormalities requiring no treatment may be enrolled. People who wheezed once or received bronchodilator therapy once in the first year of life but who have not had any additional wheezing episodes or bronchodilator therapy for at least 12 months before study entry may also be enrolled.
  • Member of a household that includes an immunocompromised individual or infants less than 12 months of age, other than a study participant
  • Attends day care with infants less than 12 months of age and whose parent/guardian is unable or unwilling to suspend daycare for 14 days following immunization. Children who attend facilities that separate children by age and minimize opportunities for transmission of virus through direct physical or aerosol contact are acceptable.
  • Receipt of another investigational vaccine or investigational drug within 28 days of receiving this investigational HMPV vaccine
  • Temporary Exclusion Criteria for All Age Groups:
  • The following are temporary or self-limiting conditions, and once resolved, the person may be enrolled, if otherwise eligible. If the period of temporary exclusion is more than 56 days for adults or HMPV-seropositive children, or more than 42 days for HMPV-seronegative children, participants will need to be rescreened.
  • Fever (adult oral temperature of greater than or equal to 100.4°F [38°C], or pediatric rectal temperature of greater than or equal to 100.4°F [38.0°C]), acute upper respiratory illness (including nasal congestion significant enough to interfere with successful vaccination), or acute otitis media
  • Received any killed vaccine or live attenuated rotavirus vaccine within the 2 weeks before study entry, any other live vaccine within the 4 weeks before study entry, or gamma globulin (or other antibody products) within the 3 months before study entry
  • Received antibiotics or systemic or nasal steroid therapy for acute illness within the previous 3 days prior to vaccination (topical steroids and topical antibiotics or antifungal preparations are permitted)
  • Infant or child participant has received salicylate (aspirin) or salicylate-containing products within the 1 month before study entry
  • Children born at less than 37 weeks gestation will be deferred from participation until they are at least 1 year of age

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health

    Baltimore, Maryland, 21205

  • Seattle Children's Hospital

    Seattle, Washington, 98191

Other trials in United States

About this study

Official title: A Phase I Study of the Safety and Immunogenicity of the Recombinant Live-Attenuated Human Metapneumovirus Vaccine, rHMPV-Pa Lot HMPV #101A, Delivered as Nose Drops to Adults 18 to 49 Years of Age, HMPV-Seropositive Children 12 to 59 Months of Age, and HMPV-Seronegative Infants and Children 6 to 59 Months of Age

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.

Read the 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.

Conditions
Metapneumovirus
Being tested
10^6 PFU rHMPV-Pa vaccine, 10^5 PFU rHMPV-Pa vaccine, Placebo Vaccine

What participants receive

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

  • 10^6 PFU rHMPV-Pa vaccineBiological

    Single dose of 10^6 PFU rHMPV-Pa vaccine delivered intranasally

  • 10^5 PFU rHMPV-Pa vaccineBiological

    Single dose of 10^5 PFU rHMPV-Pa vaccine delivered intranasally

  • Placebo VaccineBiological

    Single dose of placebo vaccine delivered intranasally

Study groups in NCT01255410
Study groupRoleWhat they receive
Healthy Adults (Group 1)ExperimentalHealthy adults will receive a single dose of 10^6 plaque forming unit (PFU) rHMPV-Pa vaccine intranasally.
Receives: Biological: 10^6 PFU rHMPV-Pa vaccine
Seropositive Children-Vaccine (Group 2)ExperimentalSeropositive children will receive a single dose of 10^6 PFU rHMPV-Pa vaccine intranasally.
Receives: Biological: 10^6 PFU rHMPV-Pa vaccine
Seropositive Children-Placebo (Group 2)Placebo comparatorSeropositive children will receive a single dose of placebo vaccine intranasally.
Receives: Biological: Placebo Vaccine
Seronegative Infants and Children-Vaccine (10^5) (Group 3)ExperimentalSeronegative infants and children will receive a single dose of 10^5 PFU rHMPV-Pa vaccine intranasally.
Receives: Biological: 10^5 PFU rHMPV-Pa vaccine
Seronegative Infants and Children-Placebo (Group 3)Placebo comparatorSeronegative infants and children will receive a single dose of placebo vaccine intranasally.
Receives: Biological: Placebo Vaccine
Seronegative Infants and Children-Vaccine (10^6) (Group 4)ExperimentalSeronegative infants and children will receive a single dose of 10^6 PFU rHMPV-Pa vaccine intranasally.
Receives: Biological: 10^6 PFU rHMPV-Pa vaccine
Seronegative Infants and Children-Placebo (Group 4)Placebo comparatorSeronegative infants and children will receive a single dose of placebo vaccine intranasally.
Receives: Biological: Placebo Vaccine

What is being measured

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

  1. Frequency of vaccine-related reactogenicity events that occur during the acute monitoring phase of the study

    Measured: Measured at Days 0-12 for adult and seropositive participants, Days 0-28 for seronegative participants

  2. Proportion of participants that develop 4-fold or greater rises in human metapneumovirus (HMPV) neutralizing antibody titer following vaccination.

    Measured: Measured following the vaccination

Secondary outcomes (1)

  1. The number of vaccinated children and infants infected with rHMPV-Pa

    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 posted7 Dec 2010 (estimated)
  2. Study startJan 2011
  3. Primary completionOct 2014
  4. Study completionJan 2015

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01255410
Sponsor's protocol ID
CIR 271
Status last verified
Dec 2015
First submitted
6 Dec 2010
Last updated
15 Dec 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Herfst S, Fouchier RA. Vaccination approaches to combat human metapneumovirus lower respiratory tract infections. J Clin Virol. 2008 Jan;41(1):49-52. doi: 10.1016/j.jcv.2007.10.022. Epub 2007 Dec 4.

    PubMed 18054841

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 10^6 PFU rHMPV-Pa vaccine and 10^5 PFU rHMPV-Pa vaccine in people with Metapneumovirus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites 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 13 inclusion and 52 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 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 vaccine-related reactogenicity events that occur during the acute monitoring phase of the study (time frame: Measured at Days 0-12 for adult and seropositive participants, Days 0-28 for seronegative participants). The study lists 2 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 NCT01255410, which also lists 2 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 15 Dec 2015.

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