Status:
COMPLETED
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
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Sanofi Pasteur, a Sanofi Company
Conditions:
RSV Infection
Eligibility:
All Genders
6-24 years
Phase:
PHASE1
Brief Summary
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 R...
Detailed 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 ...
Eligibility Criteria
Inclusion
- ≥ 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
Exclusion
- ≤ 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
- a person who has cancer and has received chemotherapy within the 12 months prior to enrollment
- a person living with a solid organ or bone marrow transplant
- 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:
- inactivated influenza vaccine within 3 days prior, or
- any other inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days prior, or
- any live vaccine, other than rotavirus vaccine, within the 28 days prior, or
- another investigational vaccine or investigational drug within 28 days prior, or
- salicylate (aspirin) or salicylate-containing products within the past 28 days
- Scheduled administration of any of the following after planned inoculation
- inactivated vaccine or live-attenuated rotavirus vaccine within the 14 days after, or
- any live vaccine other than rotavirus in the 28 days after, or
- another investigational vaccine or investigational drug in the 56 days after
- Receipt of any of the following medications within 3 days of study enrollment:
- systemic antibacterial, antiviral, antifungal, anti-parasitic, or antituberculous agents, whether for treatment or prophylaxis, or
- intranasal medications, or
- other prescription medications except the permitted concomitant medications listed below
- 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:
- fever (temporal or rectal temperature of ≥100.4°F), or
- upper respiratory signs or symptoms (rhinorrhea, cough, or pharyngitis) or
- nasal congestion significant enough to interfere with successful inoculation, or
- otitis media
- contact with a person diagnosed with COVID-19 disease or active severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) infection within the preceding 10 days
Key Trial Info
Start Date :
March 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2024
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT04520659
Start Date
March 16 2022
End Date
April 18 2024
Last Update
August 22 2025
Active Locations (3)
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1
John Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205
2
University of Rochester Medical Center
Rochester, New York, United States, 14642
3
Vanderbilt University
Nashville, Tennessee, United States, 37232