What side effects are associated with this type of intervention?

Live-attenuated vaccines for RSV, such as RSV 6120/∆NS1 or RSV 6120/F1/G2/∆NS1, are generally well-tolerated with no significant side effects reported in the trials. Similarly, aerosolized ribavirin, another treatment for RSV, has shown no associated side effects or toxicity. Overall, these treatments appear to be safe based on current studies.

What prior FDA approvals exist?

The FDA has approved several treatments for Respiratory Syncytial Virus (RSV), primarily focusing on prophylactic measures rather than live-attenuated vaccines. Palivizumab, a monoclonal antibody, is one of the key FDA-approved treatments used to prevent severe RSV infection in high-risk infants and children. While live-attenuated vaccines like RSV 6120/∆NS1 or RSV 6120/F1/G2/∆NS1 are currently under study, there have been no FDA approvals for such vaccines to date. The focus remains on developing effective vaccines that can stimulate an immune response against RSV.

What other types of research exist?

Promising novel alternatives to live-attenuated RSV vaccines include subunit vaccines like the RSV F protein nanoparticle vaccine, vector-based vaccines such as the adenovirus-vectored RSV vaccine, and mRNA vaccines targeting RSV. These alternatives have shown potential in stimulating robust immune responses and are currently being evaluated in clinical trials.

← Back to Search

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

Select...

My growth is normal for my age, with height and weight above the 3rd percentile.

Select...

I am between 1 and 5 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am receiving treatment for a heart condition.

Select...

I have had wheezing or used a bronchodilator in the last year.

Select...

I have received a bone marrow or organ transplant.

Select...

I have had wheezing or used inhalers after turning 1 year old.

Select...

I have a lung condition or asthma.

Select...

I have not received any blood products in the last 6 months.

Select...

I had a severe reaction to a vaccine before.

Select...

I currently have a fever, upper respiratory symptoms, or severe nasal congestion.

Select...

I have received or will receive treatment for RSV with specific medications.

Select...

I am not scheduled to receive certain vaccines or investigational drugs soon after the planned treatment.

Select...

I haven't taken antibiotics, antivirals, antifungals, anti-parasitics, or certain other meds in the last 3 days.

Select...

I do not have major birth defects like cleft palate or genetic abnormalities.

Select...

I have used supplemental oxygen at home before.

Select...

I have had more than one wheezing episode in my first year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured through participants' last study visit at 6 to 13 months, depending on when participants enroll in the study

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.

0 / 16Eligibility criteria met

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.

The role of resveratrol, Sirtuin1 and RXRα as prognostic markers in ovarian cancer.