Evaluating the Safety and Immune Response to a Respiratory Syncytial Virus (RSV) Vaccine in Adults, RSV-Seropositive Children, and RSV-Seronegative Infants and Children
Phase 1
Completed
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- Biological: RSV MEDI ΔM2-2 vaccineBiological: Placebo vaccine
- Registration Number
- NCT01459198
- Brief Summary
Human respiratory syncytial virus (RSV) is a common cause of upper respiratory tract illnesses as well as more severe lower respiratory illnesses, including bronchiolitis and pneumonia. RSV affects almost all children within the first 2 years of life. This study will evaluate the safety and immune response to the RSV MEDI ΔM2-2 vaccine among adults, RSV-seropositive children, and RSV-seronegative infants and children.
- Detailed Description
The purpose of this study is to evaluate the safety and immune response of the RSV MEDI ΔM2-2 vaccine in the four groups of participants. The study vaccine will be evaluated in adults, in RSV-seropositive children, and in a dose-ranging study in two groups of RSV-seronegative infants and children.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Seronegative Infants and Children: Vaccine (Group 3) RSV MEDI ΔM2-2 vaccine Seronegative infants and children will receive one dose of the 10\^5 RSV MEDI ΔM2-2 vaccine intranasally. Seronegative Infants and Children: Placebo Vaccine (Group 3) Placebo vaccine Seronegative infants and children will receive one dose of the placebo vaccine intranasally. Seronegative Infants and Children: Vaccine (Group 4) RSV MEDI ΔM2-2 vaccine Seronegative infants and children will receive one dose of the 10\^6 RSV MEDI ΔM2-2 vaccine intranasally. Seropositive Children: Placebo Vaccine (Group 2) Placebo vaccine Seropositive children will receive one dose of the placebo vaccine intranasally. Seropositive Children: Vaccine (Group 2) RSV MEDI ΔM2-2 vaccine Seropositive children will receive one dose of the 10\^6 RSV MEDI ΔM2-2 vaccine intranasally. Adults: Vaccine (Group 1) RSV MEDI ΔM2-2 vaccine Adult participants will receive one dose of the 10\^6 RSV MEDI ΔM2-2 vaccine intranasally. Seronegative Infants and Children: Placebo Vaccine (Group 4) Placebo vaccine Seronegative infants and children will receive one dose of the placebo vaccine intranasally.
- Primary Outcome Measures
Name Time Method List the individual clinical solicited AEs and other AEs, graded by severity. These will be displayed in tabular format and stratified by group. Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children Where appropriate, chi-square or Fisher's exact test will be used to determine significant differences between groups Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children Summarize the frequency of solicited adverse events (AEs) and other AEs Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children
- Secondary Outcome Measures
Name Time Method Where appropriate, the Mann-Whitney U test or Tukey-Kramer multiple comparison post-test will be used to determine significant differences between groups Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children List the peak titer and duration of virus shed by each individual participant. Data will be displayed in tabular format. Mean peak titer and mean duration of shedding will be calculated. Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children List the RSV antibody titer pre- and post-vaccination for each individual participant. Data will be displayed in tabular format. Mean antibody titers will be determined. Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children Determine the infectivity of the vaccine, defined as the proportion of vaccinees who either shed vaccine virus and/or had a fourfold or greater rise in serum antibody titer following vaccination Measured through Day 28 for adults and seropositive children and through Day 56 for seronegative infants and children
Trial Locations
- Locations (1)
John Hopkins Center for Immunization Research
🇺🇸Baltimore, Maryland, United States