Status:
COMPLETED
Safety of and Immune Response to Recombinant Live-Attenuated Parainfluenza Type 1 Virus Vaccine
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Johns Hopkins Bloomberg School of Public Health
Conditions:
Parainfluenza
Virus Diseases
Eligibility:
All Genders
6-49 years
Phase:
PHASE1
Brief Summary
Human Parainfluenza Virus Type 1 (HPIV1) is a leading cause of viral respiratory infections in children, the elderly, and those with compromised immune systems. HPIV1 is also the leading cause of vira...
Detailed Description
HPIV1 infection can result in severe respiratory illness that often leads to the hospitalization of infants and young children. HPIV1 is responsible for approximately 6% of all pediatric hospitalizati...
Eligibility Criteria
Inclusion
- Adult
- In good health
- Available for the duration of the trial
- Available for post-inoculation telephone contact
- For females, must agree to use effective birth control methods for the duration of the study
- Seropositive Children
- In good health
- Seropositive for HPIV1
- Available for the duration of the study
- Seronegative Infants and Children
- In good health
- Seronegative for HPIV1 antibody
- Available for the duration of the study
- Adult
Exclusion
- Neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease
- Condition, in the opinion of the investigator, that will not allow the participant to comply with the protocol
- Alcohol or drug abuse
- History of anaphylaxis
- History of splenectomy
- Diagnosis of asthma within 2 years of study entry
- HIV-infected
- Hepatitis C infection
- Hepatitis B infection
- Abnormal urinalysis
- Known immunodeficiency syndrome
- Current use of nasal or systemic steroid medications
- Receipt of blood products within 3 months of study entry
- Current smoker unwilling to stop smoking for the duration of the study. The decision to exclude a potential subject is made by the investigator based upon the potential subject's medical history and physical examination.
- Participation in another investigational vaccine or drug trial within 30 days of receiving the investigational vaccine
- Receipt of live vaccine within 4 weeks or a killed vaccine within 2 weeks or immune globin within 3 months prior to receiving the investigational vaccine
- Previous immunization with an HPIV1 vaccine
- Known hypersensitivity to any vaccine component
- Participants whose profession and/or personal responsibilities involve caring for children less than 6 months of age or for immunosuppressed individuals
- Persistent systolic blood pressure more than 140 mm Hg or diastolic pressure more than 90 mm Hg
- Body mass index (BMI) more than 35
- Pregnant or breastfeeding
- Seropositive and Seronegative Infants and Children
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00641017
Start Date
March 1 2008
End Date
July 1 2012
Last Update
February 25 2013
Active Locations (1)
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1
Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205