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Virus Therapy

RSV Vaccines 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
Growing normally for age as demonstrated on a standard growth chart and has a current height and weight above the 3rd percentile for age
Greater than or equal to 12 months of age and less than 60 months of age at the time of inoculation
Must not have
Cardiac abnormality requiring treatment
Wheezing episode or received bronchodilator therapy within the past 12 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured through participants' last study visit at 6 to 13 months, depending on when participants enroll in the study

Summary

This trial is testing two types of weakened RSV vaccines in children to see if these vaccines can safely help their bodies learn to fight off the virus.

Who is the study for?
This trial is for children aged 6 to 59 months who have either been previously exposed to RSV (seropositive) or not (seronegative). Participants must be in good health, with normal growth and up-to-date vaccinations. They cannot join if they were born very prematurely, have a history of severe vaccine reactions, chronic diseases, immune system problems, or recent use of certain medications.
What is being tested?
The study tests two live-attenuated RSV vaccines: RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1 against a placebo. It aims to assess how well these vaccines create an immune response in young children and monitor their safety.
What are the potential side effects?
Possible side effects are not detailed but may include typical vaccine-related reactions such as soreness at the injection site, fever, irritability, and mild respiratory symptoms. Severe allergic reactions are rare but possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My growth is normal for my age, with height and weight above the 3rd percentile.
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I am between 1 and 5 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am receiving treatment for a heart condition.
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I have had wheezing or used a bronchodilator in the last year.
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I have received a bone marrow or organ transplant.
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I have had wheezing or used inhalers after turning 1 year old.
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I have a lung condition or asthma.
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I have not received any blood products in the last 6 months.
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I had a severe reaction to a vaccine before.
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I currently have a fever, upper respiratory symptoms, or severe nasal congestion.
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I have received or will receive treatment for RSV with specific medications.
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I am not scheduled to receive certain vaccines or investigational drugs soon after the planned treatment.
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I haven't taken antibiotics, antivirals, antifungals, anti-parasitics, or certain other meds in the last 3 days.
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I do not have major birth defects like cleft palate or genetic abnormalities.
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I have used supplemental oxygen at home before.
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I have had more than one wheezing episode in my first year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured through participants' last study visit at 6 to 13 months, depending on when participants enroll in the study
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured through participants' last study visit at 6 to 13 months, depending on when participants enroll in the study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Duration of virus shedding in nasal washes (RSV-seronegative participants)
Duration of virus shedding in nasal washes (RSV-seropositive participants)
Frequency of a greater than or equal to 4-fold rise in IgG antibody responses to RSV F glycoprotein (RSV-seronegative participants)
+13 more
Secondary study objectives
Frequency of antibody responses in the RSV-seronegative vaccine and placebo recipients who experience natural infection with wt RSV during the RSV season
Frequency of symptomatic, medically attended respiratory and febrile illness in the RSV-seronegative (group 2) vaccine and placebo recipients who experience natural infection with wt RSV during the RSV season
Measurement of mucosal antibody titers to vaccine
+1 more

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 2: RSV 6120/∆NS1 VaccineExperimental Treatment1 Intervention
Healthy RSV-seronegative infants and children greater than or equal to 6 months to less than 25 months will receive a single dose of 10\^5.0 PFUs of RSV 6120/∆NS1 vaccine at Day 0.
Group II: Group 2: RSV 6120/F1/G2/∆NS1Experimental Treatment1 Intervention
Healthy RSV-seronegative infants and children greater than or equal to 6 months to less than 25 months will receive a single dose of 10\^5.0 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.
Group III: Group 1: RSV 6120/∆NS1 VaccineExperimental Treatment1 Intervention
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^6.0 plaque-forming units (PFUs) of RSV 6120/∆NS1 vaccine at Day 0.
Group IV: Group 1: RSV 6120/F1/G2/∆NS1 VaccineExperimental Treatment1 Intervention
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of 10\^5.8 PFUs of RSV 6120/F1/G2/∆NS1 vaccine at Day 0.
Group V: Group 2: PlaceboPlacebo Group1 Intervention
Healthy RSV-seronegative infants and children greater than or equal to 6 months to less than 25 months will receive a single dose of placebo at Day 0.
Group VI: Group 1: PlaceboPlacebo Group1 Intervention
Healthy RSV-seropositive children greater than or equal to 12 months to less than 60 months will receive a single dose of placebo at Day 0.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Respiratory Syncytial Virus (RSV) include supportive care, antiviral medications, and vaccines. Supportive care involves managing symptoms and ensuring adequate oxygenation and hydration. Antiviral medications like ribavirin can inhibit viral replication, though their use is limited. Live-attenuated vaccines, such as RSV 6120/∆NS1 or RSV 6120/F1/G2/∆NS1, work by stimulating the immune system to recognize and fight the virus without causing the disease. These vaccines are designed to be safe and effective, especially in young children who are at high risk for severe RSV infections. By inducing a strong immune response, these vaccines can potentially reduce the incidence and severity of RSV infections, thereby decreasing hospitalizations and improving patient outcomes.
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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
3,312 Previous Clinical Trials
5,546,486 Total Patients Enrolled
Ruth A. Karron, MDPrincipal InvestigatorCenter for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health (JHSPH)
19 Previous Clinical Trials
878 Total Patients Enrolled

Media Library

RSV 6120/F1/G2/∆NS1 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03596801 — Phase 1
Respiratory Syncytial Virus Clinical Trial 2023: RSV 6120/F1/G2/∆NS1 Highlights & Side Effects. Trial Name: NCT03596801 — Phase 1
Respiratory Syncytial Virus Research Study Groups: Group 1: RSV 6120/F1/G2/∆NS1 Vaccine, Group 2: RSV 6120/∆NS1 Vaccine, Group 2: Placebo, Group 1: Placebo, Group 2: RSV 6120/F1/G2/∆NS1, Group 1: RSV 6120/∆NS1 Vaccine
RSV 6120/F1/G2/∆NS1 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03596801 — Phase 1
~8 spots leftby Oct 2025