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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Collaborator: |
Johns Hopkins Bloomberg School of Public Health |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00641017 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Parainfluenza Virus Diseases |
Biological: rHPIV1 84/del170/942A, Lot PIV1 #104A vaccine Biological: Placebo |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| 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 |
| Estimated Enrollment: | 110 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1 and 2 - Adults
One immunization of 1x10^6 TCID50 rHPIV1 84/del170/942A administered intranasally via nose drops at study entry
|
Biological: rHPIV1 84/del170/942A, Lot PIV1 #104A vaccine
Live attenuated Human Parainfluenza Type 1 Virus Vaccine
|
|
Experimental: 3A - Seropositive Children
One immunization of 1x10^6 TCID50 rHPIV1 84/del170/942A administered intranasally via nose drops at study entry
|
Biological: rHPIV1 84/del170/942A, Lot PIV1 #104A vaccine
Live attenuated Human Parainfluenza Type 1 Virus Vaccine
|
|
Placebo Comparator: 3B - Seropositive Children
One dose of 1x10^6 TCID50 rHPIV1 84/del170/942A placebo administered intranasally via nose drops at study entry
|
Biological: Placebo
Placebo for rHPIVI1 84/del170/942A, Lot PIV1 #104A vaccine
|
|
Experimental: 4A - Seronegative Infants and Children
One immunization of 1x10^5 TCID50 rHPIV1 84/del170/942A administered intranasally via nose drops at study entry
|
Biological: rHPIV1 84/del170/942A, Lot PIV1 #104A vaccine
Live attenuated Human Parainfluenza Type 1 Virus Vaccine
|
|
Placebo Comparator: 4B - Seronegative Infants and Children
One dose of 1x10^5 TCID50 rHPIV1 84/del170/942A placebo administered intranasally via nose drops at study entry
|
Biological: Placebo
Placebo for rHPIVI1 84/del170/942A, Lot PIV1 #104A vaccine
|
|
Experimental: 5A - Seronegative Infants and Children
One immunization of 1x10^6 TCID50 rHPIV1 84/del170/942A administered intranasally via nose drops at study entry
|
Biological: rHPIV1 84/del170/942A, Lot PIV1 #104A vaccine
Live attenuated Human Parainfluenza Type 1 Virus Vaccine
|
|
Placebo Comparator: 5B - Seronegative Infants and Children
One dose of rHPIV1 84/del170/942A placebo administered intranasally via nose drops at study entry
|
Biological: Placebo
Placebo for rHPIVI1 84/del170/942A, Lot PIV1 #104A vaccine
|
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 hospitalizations for respiratory tract diseases and is a main cause of severe lower respiratory tract diseases, including pneumonia and bronchiolitis in children less than 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 5 main volunteer group: first in adults (group 1 and 2), and then in seropositive children (group 3). The last 2 groups will be seronegative infants and children that are split into 2 dosing groups; one group of seronegative infants and children will receive a lower dose of vaccine (group 4) and a second group of seronegative infants and children (group 5) will receive a higher dose of vaccine. This study will last approximately 8 weeks per group. Additional information about each of the groups is as follows:
Groups 1 and 2 will consist of 35 adults total, 18 to 49 years of age. These groups will receive one immunization with rHPIV1 84/del170/942A at study entry. Immunization will be given as nose drops. Study visits will occur on Days 3, 4, 5, 6, 7, 10, and 28. Medical history, vital signs, clinical assessment, and nasal wash will occur at most visits. Blood and urine tests will occur at selected visits. A urine pregnancy test will occur for females at study entry. Follow-up phone reports will also be required on Day 56.
Enrollment into Group 3 will begin only after safety data from Groups 1 and 2 are evaluated. Group 3 will consist of 15 seropositive children, 15 to 59 months of age. This group will receive either one immunization of rHPIV1 84/del170/942A or placebo at study entry. Immunization will be given as nose drops. Study visits will occur on Days 3, 4, 5, 6, 7, 10, and 28. Medical history, vital signs, clinical assessment, and nasal wash will occur at most visits. Blood and urine tests will occur at selected visits. Parents will be required to submit reports over the phone throughout the study. These reports will include the temporal temperature from the previous day.
Enrollment into Group 4 will begin only after safety data from Group 3 are evaluated. Group 4 will consist of 21-30 seronegative infants and children, 6 to 59 months of age. This group will receive either one immunization of rHPIV1 84/del170/942A or placebo at study entry. Immunization will be given as nose drops. Study visits will occur on Days 3, 5, 7, 10, 12, 14, 17, 19, 21, 28, and 56. Medical history, vital signs, clinical assessment, and nasal wash will occur at most visits. Blood tests will occur at selected visits. Parents will be required to submit reports over the phone throughout the study. These reports will include the temporal temperature from the previous day.
Enrollment into Group 5 will begin only after safety data from Group 4 are evaluated. Group 5 will consist of 21-30 seronegative infants and children 6 to 59 months of age. This group will receive either one immunization of rHPIV1 84/del170/942A or placebo at study entry. The immunization will be given as nose drops. The vaccine dosage that participants receive in Group 5 will be greater than the dose in Group 4. Study visits will occur on Days 3, 5, 7, 10, 12, 14, 17, 19, 21, 28, and 56. Medical history, vital signs, clinical assessment, and nasal wash will occur at most visits. Blood tests will occur at selected visits. Parents will be required to submit reports over the phone throughout the study. These reports will include the temporal temperature from the previous day.
Eligibility| Ages Eligible for Study: | 6 Months to 49 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Adult Inclusion Criteria:
Seropositive Children Inclusion Criteria:
Seronegative Infants and Children Inclusion Criteria:
Adult Exclusion Criteria:
Seropositive and Seronegative Infants and Children Exclusion Criteria:
Contacts and Locations| Contact: Karen Loehr, BSN | 410-502-3333 | kloehr@jhsph.edu |
| United States, Maryland | |
| Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health | Recruiting |
| Baltimore, Maryland, United States, 21205 | |
| Principal Investigator: | Ruth A. Karron, MD | Johns Hopkins Bloomberg School of Public Health |
More Information
| Responsible Party: | Ruth A. Karron, MD, Center for Immunization Research, Johns Hopkins School of Public Health |
| ClinicalTrials.gov Identifier: | NCT00641017 History of Changes |
| Other Study ID Numbers: | CIR 248 |
| Study First Received: | March 5, 2008 |
| Last Updated: | December 13, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Paramyxoviridae Infections Virus Diseases Mononegavirales Infections RNA Virus Infections |