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About
The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of a single dose of a recombinant, live-attenuated respiratory syncytial virus (RSV) vaccine, LID/ΔM2-2/1030s, in RSV-seronegative infants and children 6 to 24 months of age.
Full description
This study will evaluate the infectivity, safety, and immunogenicity of a single dose of a recombinant, live-attenuated respiratory syncytial virus (RSV) vaccine, LID/ΔM2-2/1030s, in RSV-seronegative infants and children 6 to 24 months of age.
Participants will be randomly assigned to one of two groups to receive a single dose of intranasal RSV LID/ΔM2-2/1030s vaccine or placebo at study entry (Day 0). Group 1 (intensive) and Group 2 (less intensive) will differ only in the frequency of study visits and nasal swab collections.
Participants will receive study product between April 1 and October 15, outside of the RSV season, and will remain on the study until they complete the post-RSV season visit between April 1 and April 30 in the calendar year following enrollment. Participants' total study duration is between 6 and 13 months, depending upon time of enrollment.
Participants will attend several study visits throughout the study, which may include blood collection, nasal swabs, and physical examinations. Some of these visits may be remote if a stay at home order is put in place after enrollment.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
≥ 6 months of age and <25 months of age at the time of inoculation
Screening and pre-inoculation serum specimens for respiratory syncytial virus (RSV)-neutralizing antibody are obtained no more than 42 days prior to inoculation
Seronegative for RSV antibody, defined as serum RSV-neutralizing antibody titer <1:40
In good health based on review of the medical record, history, and physical examination at the time of inoculation
Received routine immunizations appropriate for age based on the Advisory Committee on Immunization Practices (ACIP) Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger
Growing normally for age as demonstrated on a World Health Organization (WHO) growth chart, AND
Expected to be available for the duration of the study
Parent/guardian is willing and able to provide written informed consent
Exclusion criteria
≤ 6 months of age and > 25 months of age at the time of inoculation
Born at less than 34 weeks gestation
Born at less than 37 weeks gestation, and at the date of inoculation less than 1 year of age
Maternal history of a positive HIV test before or during pregnancy
Evidence of chronic disease
Known or suspected infection or impairment of immunological functions
Bone marrow/solid organ transplant recipient
Major congenital malformations, including congenital cleft palate or cytogenetic abnormalities
Suspected or documented developmental disorder, delay, or other developmental problem
Cardiac abnormality requiring treatment
Lung disease or reactive airway disease
More than one episode of medically diagnosed wheezing in the first year of life
Wheezing episode or received bronchodilator therapy within the past 12 months
Wheezing episode or received bronchodilator therapy after the age of 12 months
Previous receipt of supplemental oxygen therapy in a home setting
Previous receipt of an investigational RSV vaccine
Previous receipt or planned administration of anti-RSV antibody product including ribavirin, RSV Ig, or RSV mAb
Previous receipt of immunoglobulin or any antibody products within the past 6 months
Previous receipt of any blood products within the past 6 months
Previous anaphylactic reaction
Previous vaccine-associated adverse reaction that was Grade 3 or above
Known hypersensitivity to any study product component
Member of a household that contains an infant who is less than 6 months of age at the date of inoculation through the 28th day after inoculation
Member of a household that, at the date of inoculation through the 28th day after inoculation, contains an immunocompromised individual including but not limited to:
Attends a daycare facility that does not separate children by age and contains an infant <6 months of age at the date of inoculation through the 28th day after inoculation
Receipt of any of the following prior to enrollment:
Scheduled administration of any of the following after planned inoculation
Receipt of any of the following medications within 3 days of study enrollment:
Permitted concomitant medications (prescription or non-prescription) include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including (but not limited to) cutaneous (topical) steroids, topical antibiotics, and topical antifungal agents.
Any of the following events at the time of enrollment:
Primary purpose
Allocation
Interventional model
Masking
81 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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