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Virus Therapy

RSV Vaccine for Respiratory Syncytial Virus

Phase 1
Waitlist Available
Led By Ruth A. Karron, MD
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 6 months of age and <25 months of age at the time of inoculation
If < 1 year of age: has a current height and weight above the 5th percentile for age
Must not have
≤ 6 months of age and > 25 months of age at the time of inoculation
Previous receipt of any blood products within the past 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured through day 56

Summary

This trial will test the safety and effectiveness of a new RSV vaccine in young children.

Who is the study for?
This trial is for healthy RSV-seronegative infants and children aged 6 to 24 months who have received all routine immunizations. They must be growing normally according to WHO charts, with no chronic diseases, immune system issues, or severe allergies. Infants can't join if they were born prematurely (<37 weeks), had certain treatments like oxygen therapy at home, or live with someone under 6 months old or immunocompromised.
What is being tested?
The study tests a new vaccine called LID/ΔM2-2/1030s against a placebo in preventing Respiratory Syncytial Virus (RSV). Participants will receive one dose of either the vaccine or placebo to assess how well it works (immunogenicity), its safety profile, and whether it causes an infection-like response.
What are the potential side effects?
Possible side effects include typical reactions seen with vaccines such as redness or swelling at the injection site, fever, irritability, and loss of appetite. Since this is a live-attenuated vaccine designed to mimic natural infection without causing disease, mild respiratory symptoms could also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 6 and 24 months old.
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My child is under 1 year old and is above the 5th percentile in height and weight for their age.
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My height and weight are above the 3rd percentile for my age.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am between 6 and 25 months old.
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I have not received any blood products in the last 6 months.
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I have had wheezing or used inhalers after turning 1 year old.
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I was born prematurely and am currently under 1 year old.
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I have an infection or my immune system is not working properly.
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I have had more than one wheezing episode in my first year.
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I have had a severe reaction to a vaccine before.
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I have used supplemental oxygen at home before.
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I do not have major birth defects like cleft palate or genetic abnormalities.
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I have had wheezing or used a bronchodilator in the last year.
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I currently have a fever, cold symptoms, or have been in contact with someone with COVID-19 recently.
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I have received a bone marrow or organ transplant.
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I have received or will receive treatment for RSV with specific medications.
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I am receiving treatment for a heart condition.
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I have a lung condition or asthma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured through day 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured through day 56 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Frequency of Grade 1 or higher solicited adverse events (AEs)
Frequency of Grade 2 or higher lower respiratory infections (LRI)
Peak titer of vaccine virus shed
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 2: RSV LID/ΔM2-2/1030sExperimental Treatment1 Intervention
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
Group II: Group 1: RSV LID/ΔM2-2/1030sExperimental Treatment1 Intervention
Participants will receive a single dose of RSV LID/ΔM2-2/1030s vaccine at study entry (Day 0).
Group III: Group 1: PlaceboPlacebo Group1 Intervention
Participants will receive a single dose of placebo at study entry (Day 0).
Group IV: Group 2: PlaceboPlacebo Group1 Intervention
Participants will receive a single dose of placebo at study entry (Day 0).

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,322 Previous Clinical Trials
5,364,657 Total Patients Enrolled
Sanofi Pasteur, a Sanofi CompanyIndustry Sponsor
418 Previous Clinical Trials
6,108,971 Total Patients Enrolled
Ruth A. Karron, MDPrincipal InvestigatorJohns Hopkins Bloomberg School of Public Health (JHSPH)
19 Previous Clinical Trials
857 Total Patients Enrolled

Media Library

RSV LID/ΔM2-2/1030s (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04520659 — Phase 1
Respiratory Syncytial Virus Research Study Groups: Group 1: Placebo, Group 2: RSV LID/ΔM2-2/1030s, Group 2: Placebo, Group 1: RSV LID/ΔM2-2/1030s
Respiratory Syncytial Virus Clinical Trial 2023: RSV LID/ΔM2-2/1030s Highlights & Side Effects. Trial Name: NCT04520659 — Phase 1
RSV LID/ΔM2-2/1030s (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04520659 — Phase 1
~22 spots leftby Nov 2025
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