Respiratory Syncytial Virus Infections
Conditions
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.
Interventions
BIOLOGICALRSV MEDI ΔM2-2 vaccine
Given intranasally once at a baseline study visit, at a dose of 10\^5 or 10\^6 plaque-forming units (PFU), depending on study arm.
BIOLOGICALPlacebo vaccine
Given intranasally once at a baseline study visit
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 49 Years
Healthy volunteers
Yes
Inclusion criteria
for Adults: * Adult males and nonpregnant, non-nursing females 18 to 49 years old * In good health without significant medical illness, physical examination findings, or significant laboratory abnormalities in urinalysis, complete blood count (CBC), alanine aminotransferase (ALT), or creatinine, as determined by a study physician, physician assistant, or nurse practitioner * Available for the duration of the study * Willing to participate in the study as evidenced by signing the informed consent document * Female participants of childbearing potential must have negative urine pregnancy tests and must agree to use effective birth control methods (e.g., birth control pills, diaphragm and foam, condoms with spermicide, Depo-Provera) until 28 days after vaccination
Exclusion criteria
for Adults: * Pregnant, as determined by a positive urine human chorionic gonadotropin (beta-HCG) test * Breastfeeding * Females of childbearing potential who are unwilling to practice effective birth control * Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies, including urinalysis * Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the person to understand and cooperate with the study protocol * Other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a participant in the study or would render the person unable to comply with the protocol * Has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the 12 months prior to study entry * History of a severe allergic reaction or anaphylaxis * History of splenectomy * Current diagnosis of asthma within the 2 years prior to study entry * Positive enzyme-linked immunosorbent assay (ELISA) and confirmatory Western blot tests for HIV-1 * Positive ELISA and confirmatory immunoblot tests for hepatitis C virus (HCV) * Positive ELISA hepatitis B surface antigen (HBsAg) * Abnormal urinalysis/urine dip * Known immunodeficiency syndrome * Receipt of blood products (including immunoglobulin) within the 3 months prior to study entry * Current smoker unwilling to stop smoking for the duration of the study * Previous enrollment in an RSV vaccine study * Known hypersensitivity to any vaccine component * Has professional and/or personal responsibilities that involve caring for children younger than 59 months of age or for immunosuppressed individuals * Systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg * Body mass index (BMI) greater than 35 Inclusion Criteria for Seropositive Children: * Healthy children 12 to 59 months of age, whose parent/guardian understands and signs the study informed consent and agrees to vaccine administration following a detailed explanation of the study * Seropositive for RSV, defined by serum RSV neutralizing antibody titer greater than 1:40 * Person's history has been reviewed and they have undergone a physical examination indicating that s/he is in good health * Available for the duration of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 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 |
Countries
United States
Outcome results
None listed