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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
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

NCT04520659

CompletedPhase 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Conditions: RSV Infection

Interventions: RSV LID/ΔM2-2/1030s, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 6 Months to 24 Months

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
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

  * 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 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:

  * 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
Locations (3)
  • Baltimore, Maryland, United States
  • Rochester, New York, United States
  • Nashville, Tennessee, United States