Evaluating the Safety and Immunogenicity of a Human Parainfluenza Type 3 (HPIV3) Virus Vaccine in Infants and Children

Completed · Phase 1 · Has a placebo group

Conditions studied: Parainfluenza Virus 3, Human

In brief

Human parainfluenza virus type 3 (HPIV3) is a major cause of pneumonia and other respiratory diseases in infants and children. This study will evaluate the safety and immune response of an HPIV3 vaccine in infants and young children.

Key facts

Study ID: NCT01254175
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 28
Starts: 2010-12-01
Expected to finish: 2012-02-01
Last updated by the study team: 2014-12-03

Who can join

Age: 1 and older, up to 3. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Parent/guardian(s) of participants can demonstrate their understanding of the study (by taking a multiple choice questionnaire), sign the informed consent, and agree to vaccine administration following a detailed explanation of the study
Seronegative for HPIV3, as defined by serum antibody titer hemagglutination inhibition (HAI) less than or equal to 1:8, as determined within 30 days prior to inoculation
Medical history has been reviewed and a physical examination indicates that participant is in good health
In the view of the site investigator, participant has received routine immunizations appropriate for age, administered at least 2 weeks prior to study entry (inactivated and subunit vaccines and rotavirus vaccine), or at least 4 weeks prior to study entry (live vaccines except rotavirus vaccine)
Available for the entire study period and parent/guardian can be reached by telephone for post-inoculation contacts
For children born to HIV-infected women, the child can be considered HIV-uninfected if he/she has either two negative polymerase chain reaction (PCR) tests with one collected at greater than 1 month of age and one collected at greater than 4 months of age, or two negative antibody tests
If there is an immunocompromised child in the household who is less than 5 years of age, his/her last CD4 count must be greater than 15%

You may not qualify if…

Known or suspected impairment of immunological functions, HIV infection, or currently (within the 30 days prior to study entry) receiving immunosuppressive therapy, including systemic corticosteroids (NOTE: Topical steroids, topical antibiotic, and topical antifungal medications are acceptable.)
Bone marrow/solid organ transplant recipients
Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
Previous immunization with HPIV3 vaccine
Previous serious vaccine-associated adverse event or anaphylactic reaction
Known hypersensitivity to any vaccine component
Lung or heart disease, including 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 in the 12 months before study entry may also be enrolled.
Premature infants (born before 37 weeks gestation) if less than 12 months of age
Members of a household which contains immunocompromised individuals (including, but not limited to, those with HIV-related immunodeficiency, defined as CD4 count less than 300 within the 6 months prior to study entry, or any household members who have received chemotherapy within the 12 months prior to study entry). More information on this criterion can be found in the protocol.
Members of a household that contains infants less than 6 months of age
Attends day care with infants less than 6 months of age and whose parent/guardian is unable or unwilling to suspend daycare for 14 days following immunization. (Facilities that separate children by age and minimize opportunities for transmission of virus through direct physical or aerosol contact are acceptable.)
Participation in another investigational vaccine or drug trial within 30 days of receiving the investigational vaccine or until the final follow-up blood draw
Temporary Exclusion Criteria:
The following exclusion criteria are temporary or self-limiting conditions, and once resolved (after 24 hours and three normal measurements for fever) the infant may be enrolled, if otherwise eligible.
Fever (rectal temperature of greater than or equal to 100.7 F), acute upper respiratory illness (including nasal congestion significant enough to interfere with successful vaccination), or acute otitis media
Received any killed or subunit vaccine or rotavirus vaccine within the last 2 weeks; any live vaccine, except rotavirus, within the last 4 weeks; or gamma globulin (or other antibody products) within the past 3 months
Received short-term systemic antibiotics for an acute illness within the 5 days prior to vaccination, or is currently receiving long-term prophylactic antibiotics (NOTE: Topical steroids, topical antibiotics, or topical antifungal preparations are permitted.)
Received aspirin or aspirin-containing products within the 30 days prior to study entry
Infants born at less than 37 weeks gestation will be deferred from participation until they are at least 12 months of age

Where it is running

Miller Children's Hosp. Long Beach CA NICHD CRS — Long Beach, California, United States
UCSD Mother-Child-Adolescent Program CRS — San Diego, California, United States
Rush Univ. Cook County Hosp. Chicago NICHD CRS — Chicago, Illinois, United States
Chicago Children's CRS — Chicago, Illinois, United States
Columbia IMPAACT CRS — New York, New York, United States
DUMC Ped. CRS — Durham, North Carolina, United States
Seattle Children's Hospital CRS — Seattle, Washington, United States
San Juan City Hosp. PR NICHD CRS — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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