Status:
COMPLETED
Safety of and Immune Response to a Human Parainfluenza Virus Vaccine (rHPIV3cp45) in Healthy Infants
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Johns Hopkins Bloomberg School of Public Health
Conditions:
Paramyxoviridae Infections
Virus Diseases
Eligibility:
All Genders
6-36 years
Phase:
PHASE1
Brief Summary
Human parainfluenza viruses (HPIVs) are a major health concern in infants and young children under 5 years of age, causing serious respiratory tract disease. The purpose of this study is to test the s...
Detailed Description
HPIV type 3 (HPIV3) ranks second only to respiratory syncytial virus as the most important cause of bronchiolitis and pneumonia in infants less than 6 months of age. HPIV3 can cause severe disease in ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for All Participants:
- Good general health
- Full term infant, born later than the 36th week of pregnancy
- Has received age-appropriate inactivated or subunit routine immunizations at least 2 weeks prior to study entry
- Has received age-appropriate live routine immunizations at least 4 weeks prior to study entry and at least 2 weeks for rotavirus vaccine
- Available for the duration of the trial
- Parent or guardian reachable by telephone for post-immunization contact
- Parent or guardian willing to provide informed consent
- For Group 2 participants, serum hemagglutination-inhibiting (HAI) titers to HPIV3 of or less than 1:8
- Exclusion Criteria:
- Known or suspected impairment of immunologic functions. Infants who are HIV infected, who are bone marrow or solid organ transplant recipients, or who are using immunosuppressive therapy, including systemic corticosteroids, are excluded. Infants who are using topical steroids, topical antibiotic ointments and topical antifungal agents are not excluded.
- Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
- Previously received PIV3 vaccine
- Previous serious vaccine-associated adverse event or anaphylactic reaction
- Known hypersensitivity to any vaccine component
- Lung or heart disease, including reactive airway disease. Infants with clinically insignificant cardiac abnormalities are not excluded. Infants or children 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 are not excluded.
- Born prematurely before the 37th week of pregnancy
- Member of a household containing immunocompromised individuals, pregnant caregivers, or infants less than 6 months of age
- Attends day care with infants less than 6 months of age
- Parent or guardian unable or unwilling to suspend daycare for 14 days following each immunization. More information on this criterion can be found in the protocol.
- Currently enrolled in another investigational drug or vaccine study
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00308412
Start Date
June 1 2006
End Date
April 1 2010
Last Update
July 16 2010
Active Locations (1)
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1
Center for Immunization Research, Johns Hopkins University
Baltimore, Maryland, United States, 21205