Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respirator… (NCT04520659) | Clinical Trial Compass
CompletedPhase 1
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
United States81 participantsStarted 2022-03-16
Plain-language 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 RSV-seronegative infants and children 6 to 24 months of age.
Who can participate
Age range
6 Months – 24 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of Grade 1 or Higher Solicited Adverse Events (AEs) by Grade
Timeframe: Measured through Day 28
2
Frequency of Grade 2 or Higher Lower Respiratory Infections (LRI) by Grade
Timeframe: Measured through Day 28
3
Number of Participants With Unsolicited Adverse Events (AEs) by Grade of Severity
Timeframe: Measured through Day 28
4
Number of Participants Who Experienced Serious Adverse Events (SAEs)
Timeframe: Measured Day 0 through Day 56 after inoculation and During the RSV Surveillance Season (Date of seasonal pause in enrollment in year of inoculation through March 31)
5
Percentage of Vaccinees With a ≥4-fold Rise in Serum RSV-neutralizing Antibody Titer
Timeframe: Measured at Day 0 and Day 56
6
Peak Titer of Vaccine Virus Shed by Reverse Transcription Polymerase Chain Reaction (RT-qPCR) (Group 1 Only)
Timeframe: Measured at Days 5, 7, 10, 12 and additional illness visits between Days 0 and 28.
7
Trial details
NCT IDNCT04520659
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)