NCT01255410

Brief 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 children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2010

Completed
25 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

December 15, 2015

Status Verified

December 1, 2015

Enrollment Period

3.8 years

First QC Date

December 6, 2010

Last Update Submit

December 14, 2015

Conditions

Metapneumovirus

Outcome Measures

Primary Outcomes (2)

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

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

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

    Measured following the vaccination

Secondary Outcomes (1)

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

    Measured at study completion

Study Arms (7)

Healthy Adults (Group 1)

EXPERIMENTAL

Healthy adults will receive a single dose of 10\^6 plaque forming unit (PFU) rHMPV-Pa vaccine intranasally.

Biological: 10^6 PFU rHMPV-Pa vaccine

Seropositive Children-Vaccine (Group 2)

EXPERIMENTAL

Seropositive children will receive a single dose of 10\^6 PFU rHMPV-Pa vaccine intranasally.

Biological: 10^6 PFU rHMPV-Pa vaccine

Seropositive Children-Placebo (Group 2)

PLACEBO COMPARATOR

Seropositive children will receive a single dose of placebo vaccine intranasally.

Biological: Placebo Vaccine

Seronegative Infants and Children-Vaccine (10^5) (Group 3)

EXPERIMENTAL

Seronegative infants and children will receive a single dose of 10\^5 PFU rHMPV-Pa vaccine intranasally.

Biological: 10^5 PFU rHMPV-Pa vaccine

Seronegative Infants and Children-Placebo (Group 3)

PLACEBO COMPARATOR

Seronegative infants and children will receive a single dose of placebo vaccine intranasally.

Biological: Placebo Vaccine

Seronegative Infants and Children-Vaccine (10^6) (Group 4)

EXPERIMENTAL

Seronegative infants and children will receive a single dose of 10\^6 PFU rHMPV-Pa vaccine intranasally.

Biological: 10^6 PFU rHMPV-Pa vaccine

Seronegative Infants and Children-Placebo (Group 4)

PLACEBO COMPARATOR

Seronegative infants and children will receive a single dose of placebo vaccine intranasally.

Biological: Placebo Vaccine

Interventions

10^6 PFU rHMPV-Pa vaccineBIOLOGICAL

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

Healthy Adults (Group 1)Seronegative Infants and Children-Vaccine (10^6) (Group 4)Seropositive Children-Vaccine (Group 2)
10^5 PFU rHMPV-Pa vaccineBIOLOGICAL

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

Seronegative Infants and Children-Vaccine (10^5) (Group 3)
Placebo VaccineBIOLOGICAL

Single dose of placebo vaccine delivered intranasally

Seronegative Infants and Children-Placebo (Group 3)Seronegative Infants and Children-Placebo (Group 4)Seropositive Children-Placebo (Group 2)

Eligibility Criteria

Age6 Months - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant, as determined by a positive urine beta-human chorionic gonadotropin (HCG) test
  • Breastfeeding
  • 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
  • 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
  • +42 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Baltimore, Maryland, 21205, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98191, United States

Location

Related Publications (2)

  • 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.

    PMID: 18054841BACKGROUND

  • 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.

    PMID: 14749452BACKGROUND

Study Officials

  • Ruth A. Karron, MD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

  • Janet Englund, MD

    Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2010

First Posted

December 7, 2010

Study Start

January 1, 2011

Primary Completion

October 1, 2014

Study Completion

January 1, 2015

Last Updated

December 15, 2015

Record last verified: 2015-12

Locations

US(2)