Safety of a Live Attenuated Human Parainfluenza Virus Type 2 (HPIV2) Vaccine for Adults, Children, and Infants
- Conditions
- Human Parainfluenza Virus 2
- Interventions
- Biological: Low dose HPIV2 vaccineBiological: Standard Dose HPIV2 VaccineOther: Placebo
- Registration Number
- NCT01139437
- Brief Summary
Human parainfluenza virus type 2 (HPIV2) can result in severe respiratory illness in infants and young children. This study will test the safety of and immune response to an HPIV2 vaccine aimed at infants and children.
- Detailed Description
HPIV2 is a virus that can cause severe respiratory illnesses, such as pneumonia and bronchiolitis, in infants and young children. Approximately 3% of all hospitalizations for respiratory tract diseases among infants and children are the result of HPIV2. Efforts to develop a vaccine for HPIV2 have focused on a live attenuated intranasally administered vaccine, a type of vaccine that uses a live virus that has been modified to make it weaker and easier for the immune system to get rid of. This approach is useful for several reasons: it activates two of the body's natural defenses, the antibody-mediated and the cell-mediated responses; it is immunogenic in infants who still have maternal antibodies; and it induces a mucosal immune response. This study will test the safety and immunogenicity of an HPIV2 vaccine in adults, children, and then infants.
This study will have four groups and will proceed in a step-wise fashion. The first group will consist only of adults receiving the HPIV2 vaccine. If it is deemed safe after that, children from ages 15 to 59 months who already have HPIV2 antibodies will be randomly assigned to receive either the vaccine or a placebo. The third group includes infants and children from 6 to 59 months old who do not have HPIV2 antibodies and will be randomly assigned either a lower dose of the vaccine or a placebo. The fourth group also includes infants and children from 6 to 59 months old who do not have HPIV2 antibodies and will be randomly assigned a standard dose vaccine or placebo. The vaccine will be administered as a nose drop in a single dose for all groups.
Assessments for the first two groups will take place over the 11 days following administration of the vaccine and at a 28-day follow-up. The third and fourth groups will include 22 days of assessments after vaccination, one assessment between Days 23 and 26, and assessments on Days 27, 28, 29, and 56. Measures will include a clinical assessment, a nasal wash, a phone report, and taking a temperature. Measurement of serum HPIV2 antibodies will take place at baseline and after 28 (for groups one and two) or 56 (for groups three and four) days.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Seronegative infants and children - low dose vaccine Low dose HPIV2 vaccine Infants and children ages 6 to 59 months of age who do not have HPIV2 antibodies receiving a low dose of the HPIV2 vaccine. Adults Standard Dose HPIV2 Vaccine Adults ages 18 to 49 years of age. Open label. Seropositive children - vaccine Standard Dose HPIV2 Vaccine Children ages 15 to 59 months of age who already have HPIV2 antibodies receiving the HPIV2 vaccine. Seronegative infants and children - standard dose vaccine Standard Dose HPIV2 Vaccine Infants and children ages 6 to 59 months of age who do not have HPIV2 antibodies receiving a standard dose of the HPIV2 vaccine. Seronegative infants and children - low dose placebo Placebo Infants and children ages 6 to 59 months of age who do not have HPIV2 antibodies receiving a low dose of placebo. Seropositive children - placebo Placebo Children ages 15 to 59 months of age who already have HPIV2 antibodies receiving a placebo. Seronegative infants and children - standard dose placebo Placebo Infants and children ages 6 to 59 months of age who do not have HPIV2 antibodies receiving a standard dose of placebo.
- Primary Outcome Measures
Name Time Method Immunogenicity, as determined by ability to cause an immunological reaction and amount of antibody induced by the vaccine Measured at baseline and at 1 month Safety, as determined by frequency of adverse events Measured at baseline, for 11 days after vaccination, and at 1 month follow-up Infectivity, as determined by amount of vaccine shed by each recipient Measured at baseline, for 11 days after vaccination, and at 1 month follow-up
- Secondary Outcome Measures
Name Time Method Phenotypic stability of the vaccine virus shed Measured at baseline and at 1 month Number of vaccinated infants and children infected with HPIV2 Measured at baseline, for 11 days after vaccination, and at 1 month follow-up
Trial Locations
- Locations (1)
Johns Hopkins University, Bloomberg School of Public Health
🇺🇸Baltimore, Maryland, United States