Safety of and Immune Response to Recombinant Live Attenuated Parainfluenza Type 3 Virus Vaccine in Healthy Infants and Children
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 primary purpose of this study is to test the safety of and immune response to a new HPIV vaccine in healthy infants and children.
Drug: rHPIV3cp45 placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||Phase I Study to Determine the Safety, Infectivity, and Tolerability of 2 Doses of Live Attenuated Recombinant Cold-Passaged (cp) 45 Human Parainfluenza Type 3 Virus Vaccine, rHPIV3cp45, Lot PIV3#102A, Delivered as Nose Drops to HPIV3-Seronegative Infants and Children 6 to 36 Months of Age, at a 6 Month Interval|
- Frequency of vaccine-related reactogenicity events and other adverse events [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- Amount of serum antibody induced by vaccine in each recipient [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Amount of vaccine virus shed by each recipient [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Immunogenicity of a second dose of vaccine and the protection of the first dose against re-infection with the second dose [ Time Frame: From Weeks 22 to 28 ] [ Designated as safety issue: No ]
- Number of vaccinated infants infected with rHPIV3cp45 [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- Number of vaccinated participants infected with a second dose of rHPIV3cp45 [ Time Frame: From Weeks 22 to 28 ] [ Designated as safety issue: Yes ]
- Phenotypic stability of vaccine virus shed [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Participants will receive one dose of vaccine virus at study entry and between Weeks 22 and 27
10^5 TCID50 nasal drops
Placebo Comparator: 2
Participants will receive one dose of vaccine virus placebo at study entry and between Weeks 22 and 27
Drug: rHPIV3cp45 placebo
1X-L15 nasal drops
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 the first 2 years of life and is responsible for 11% of hospitalizations for respiratory diseases in children. This study will evaluate the safety and immunogenicity of a live recombinant attenuated intranasal HPIV3 vaccine, rHPIV3cp45.
This study will last for approximately 28 weeks. Infants and children 6 months to 36 months of age will be randomly assigned to one of two groups. Group 1 participants will receive 2 immunizations of rHPIV3cp45. Group 2 participants will receive 2 doses of rHPIV3cp45 placebo. Immunizations will be given as nose drops and administered at study entry and approximately 22 to 27 weeks after study entry.
On the day of immunization, a physical exam and blood collection will occur. Participants will be observed for 15 minutes after immunization for any immediate adverse effects. Parents or guardians will be given a thermometer to take with them and will be instructed on how to take their child's temperature. They will be given the study schedule and will need to provide contact phone numbers so study personnel can contact them by phone during the days after immunization. Parents and guardians will be contacted by telephone daily from Day 1 to Day 18 after each immunization.
Parents or guardians will need to record their child's temperature daily for at least 17 days immediately following immunization. During this 17-day period, study visits will occur on Days 3, 6, and 12 after each dose of vaccine or placebo. Participants will undergo a nasal wash for a viral culture at all study visits. There will be additional follow-up visits occurring sometime between 49 and 63 days after the first dose and 28 to 35 days after the second dose; blood collection will occur at the follow-up visits. Additional visits may be required on selected days during the month after immunization. Infants who experience illness or side effects may be asked to return to the clinic for examination.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021397
|United States, Maryland|
|Center for Immunization Research (CIR), Johns Hopkins School of Public Health|
|Baltimore, Maryland, United States, 21205|
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|
|Study Chair:||Ruth A. Karron, MD||Center for Immunization Research, Johns Hopkins University School of Public Health|