Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID/ΔM2-2/1030s, in RSV-Seronegative Infants and Children 6 to 24 Months of Age
Completed · Phase 1 · Has a placebo group
Conditions studied: RSV Infection
In brief
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.
Key facts
- Study ID
- NCT04520659
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 81
- Starts
- 2022-03-16
- Expected to finish
- 2024-04-18
- Last updated by the study team
- 2026-07-20
Who can join
Age: 1 and older, up to 2. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- ≥ 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
- If < 1 year of age: has a current height and weight above the 5th percentile for age
- If ≥ 1 year of age: has a current height and weight above the 3rd percentile for age
- Expected to be available for the duration of the study
- Parent/guardian is willing and able to provide written informed consent
You may not qualify if…
- ≤ 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:
- a person who is HIV-infected
Where it is running
- John Hopkins Bloomberg School of Public Health — Baltimore, Maryland, United States
- University of Rochester Medical Center — Rochester, New York, United States
- Vanderbilt University — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.