What side effects are associated with this type of intervention?

Common side effects of treatments for Respiratory Syncytial Virus (RSV) that stimulate the immune response, such as vaccines, typically include mild symptoms like fever, irritability, and soreness at the injection site. Rarely, more severe side effects such as allergic reactions can occur.

What prior FDA approvals exist?

Currently, there are no FDA-approved curative therapies for Respiratory Syncytial Virus (RSV); the primary recommended treatment is supportive care. The context does not mention any specific FDA-approved drugs that stimulate the immune response to RSV, similar to the RSV vaccine being studied. Therefore, the focus remains on supportive care and ongoing research into potential vaccines and antiviral treatments.

What other types of research exist?

Promising novel alternatives to RSV vaccines for treating Respiratory Syncytial Virus (RSV) patients in 2024 include monoclonal antibodies like nirsevimab, which provides passive immunity by targeting the RSV F protein, and antiviral therapies such as ribavirin and new investigational drugs that inhibit RSV replication. Additionally, advancements in immunotherapy and gene editing technologies may offer new avenues for treatment.

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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

Healthy children at least 12 but less than 60 months of age, whose parent/guardian understands and signs the study informed consent and who agrees to vaccine administration following a detailed explanation of the study

Be younger than 18 years old

Must not have

History of any lymphoproliferative disorder

History of active malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured through follow-up period, up to 1 year after study entry

Summary

This trial tests a new RSV vaccine given as nose drops to help protect against lung infections caused by the RSV virus. It involves healthy children and infants, including those who have and have not had an RSV infection before. The vaccine works by teaching the body to recognize and fight the virus.

Who is the study for?

This trial is for healthy infants and children aged 12 to 59 months. It includes those who have had RSV before (seropositive) and those who haven't (seronegative), as well as younger infants not screened for RSV. Participants must be in good health, available for the study duration, and have parental consent.

What is being tested?

The trial tests a new vaccine called RSV ΔNS2 Δ1313 I1314L against a placebo to see if it's safe and how well it triggers an immune response in kids with different histories of RSV infection.

What are the potential side effects?

While specific side effects are not listed, vaccines like this could potentially cause reactions at the injection site, fever, irritability or discomfort in young children.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child is between 1 and 5 years old and I agree to them receiving a vaccine for a study.

Exclusion Criteria

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

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I have had a condition where my lymphocytes grow abnormally.

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I have a history of cancer.

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I have a weakened immune system, possibly due to HIV, steroids, or an organ transplant.

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I do not have major birth defects, genetic disorders, or serious long-term illnesses.

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I have been vaccinated against RSV or received/planned to receive an anti-RSV treatment.

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I have lung or heart disease, including wheezing or reactive airway disease.

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I live with someone who has a weak immune system or a baby under 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured through follow-up period, up to 1 year after study entry

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured through follow-up period, up to 1 year after study entry

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured through follow-up period, up to 1 year after study entry for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants that develop 4-fold or greater rises in RSV neutralizing antibody titer following vaccination

Trial Design

8Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 4: RSV vaccineExperimental Treatment1 Intervention

Healthy infants between the ages 4 to 6 months who have not been screened for RSV serostatus will receive one dose of the RSV ΔNS2 Δ1313 I1314L vaccine administered as nose drops at study entry.

Group II: Group 3: RSV vaccineExperimental Treatment1 Intervention

Healthy RSV-seronegative infants and children ages 6 to 24 months will receive one dose of the RSV ΔNS2 Δ1313 I1314L vaccine administered as nose drops at study entry.

Group III: Group 2: RSV vaccineExperimental Treatment1 Intervention

Healthy RSV-seronegative infants and children ages 6 to 24 months will receive one dose of the RSV ΔNS2 Δ1313 I1314L vaccine administered as nose drops at study entry.

Group IV: Group 1: RSV vaccineExperimental Treatment1 Intervention

Healthy RSV-seropositive children ages 12 to 59 months will receive one dose of the RSV ΔNS2 Δ1313 I1314L vaccine administered as nose drops at study entry.

Group V: Group 4: PlaceboPlacebo Group1 Intervention

Healthy infants between the ages 4 to 6 months who have not been screened for RSV serostatus will receive one dose of the placebo administered as nose drops at study entry.

Group VI: Group 2: PlaceboPlacebo Group1 Intervention

Healthy RSV-seronegative infants and children ages 6 to 24 months will receive one dose of the placebo administered as nose drops at study entry.

Group VII: Group 3: PlaceboPlacebo Group1 Intervention

Healthy RSV-seronegative infants and children ages 6 to 24 months will receive one dose of the placebo administered as nose drops at study entry.

Group VIII: Group 1: PlaceboPlacebo Group1 Intervention

Healthy RSV-seropositive children ages 12 to 59 months will receive one dose of the placebo administered as nose drops at study entry.

0 / 8Eligibility 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) primarily involve supportive care, such as oxygen therapy and hydration, as there are no curative therapies currently available. However, vaccines like the one being studied aim to stimulate the immune system to recognize and fight RSV. These vaccines work by introducing a component of the virus to the body, prompting an immune response that prepares the body to combat the actual virus if encountered. This is crucial for RSV patients, especially infants and young children, as it can potentially reduce the severity and duration of the illness, preventing complications and hospitalizations.

New therapies for acute RSV infections: where are we?