Virus Diseases Clinical Trial
Official title:
A Phase I Study of the Safety and Immunogenicity of the Recombinant Live-Attenuated Human Parainfluenza Type 1 Virus Vaccine, rHPIV1 84/del170/942A, Lot PIV1 #104A, Delivered as Nose Drops to Adults 18 to 49 Years of Age, HPIV1-Seropositive Children 15 to 59 Months of Age, and HPIV1-Seronegative Infants and Children 6 to 59 Months of Age
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 viral croup in children under 6 years old. The purpose of this study is to determine the safety of and immune response to a HPIV1 vaccine, rHPIVI1 84/del170/942A, in 2 groups of adults and then in children who have been previously exposed to HPIV1. Once the safety of this vaccine has been established in these groups, an additional 2 groups of infants and children who have not been previously exposed to HPIV1 will be vaccinated. Naïve infants and children are the most vulnerable to naturally circulating HPIV1 and are the target population of this vaccine.
Status | Completed |
Enrollment | 87 |
Est. completion date | July 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Months to 49 Years |
Eligibility |
Adult Inclusion Criteria: - 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 Inclusion Criteria: - In good health - Seropositive for HPIV1 - Available for the duration of the study Seronegative Infants and Children Inclusion Criteria: - In good health - Seronegative for HPIV1 antibody - Available for the duration of the study Adult Exclusion Criteria: - 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 Exclusion Criteria: - Known or suspected impairment of immunological functions as determined by the investigator - Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders - Previous immunization with HPIV1 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 reactive airway disease as determined by the investigator - Member of household that includes an immunocompromised individual or infant less than 6 months of age - Attends day care with infants less than 6 months of age or immunosuppressed individuals. More information about this criterion can be found in the protocol. - Participation in another investigational vaccine or drug trial within 30 days of receiving the investigational vaccine or while study is occurring |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) | Johns Hopkins Bloomberg School of Public Health |
United States,
Bartlett EJ, Amaro-Carambot E, Surman SR, Collins PL, Murphy BR, Skiadopoulos MH. Introducing point and deletion mutations into the P/C gene of human parainfluenza virus type 1 (HPIV1) by reverse genetics generates attenuated and efficacious vaccine candidates. Vaccine. 2006 Mar 24;24(14):2674-84. Epub 2005 Nov 15. — View Citation
Bartlett EJ, Castaño A, Surman SR, Collins PL, Skiadopoulos MH, Murphy BR. Attenuation and efficacy of human parainfluenza virus type 1 (HPIV1) vaccine candidates containing stabilized mutations in the P/C and L genes. Virol J. 2007 Jul 2;4:67. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of vaccine-related reaction events and other adverse events in each cohort | Throughout study | Yes | |
Primary | Amount of vaccine virus shed by each participant | Throughout study | No | |
Primary | Amount of serum antibody and mucosal antibody induced by the vaccine in each participant | Throughout study | No | |
Secondary | Phenotypic stability of vaccine virus shed | Throughout study | No | |
Secondary | Number of vaccinated children and infants infected with rHPIV1 | Throughout study | No |
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