RSV Vaccines for Respiratory Syncytial Virus
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two new vaccines to evaluate their safety and effectiveness against respiratory syncytial virus (RSV), which can cause serious lung infections. Researchers aim to determine if these vaccines can benefit children who have either been exposed to RSV before or have not. Healthy children, regardless of previous RSV exposure, might be suitable candidates. The trial involves receiving one dose of the vaccine or a placebo (a shot with no active medicine) and seeks participants without recent lung issues or wheezing. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive a new vaccine.
Do I need to stop my current medications to join the trial?
You may need to stop certain medications before joining the trial. Specifically, you cannot take antibiotics, antivirals, antifungals, antiparasitics, or intranasal medications within 3 days of enrollment. Some medications like nutritional supplements and topical treatments are allowed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1 vaccines are in early testing stages, focusing mainly on safety. These vaccines appear promising in protecting against respiratory syncytial virus (RSV). However, detailed safety information for humans remains limited due to the early research stage.
Other studies have generally found that RSV vaccines like these are well-tolerated, with most people not experiencing serious side effects. Common reactions, if they occur, are usually mild, such as soreness at the injection site or a slight fever. While these early tests closely monitor safety, more time and research are needed to fully understand all potential risks.
Currently, trials are carefully monitoring these vaccines to ensure safety for children at risk of RSV.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the RSV 6120/F1/G2/∆NS1 and RSV 6120/∆NS1 vaccines because they offer a novel approach to preventing Respiratory Syncytial Virus (RSV) in children. Unlike current options like palivizumab, which is a monoclonal antibody given monthly to high-risk infants, these vaccines are designed to potentially provide immunity with just a single dose. The vaccines also incorporate genetic modifications, such as the deletion of the NS1 gene, which may enhance the immune response while maintaining safety. This could mean better protection with fewer doses, making them a promising alternative to existing preventive measures.
What evidence suggests that this trial's vaccines could be effective for RSV?
This trial will evaluate two different RSV vaccines. Studies have shown that the RSV 6120/F1/G2/∆NS1 vaccine, which participants in this trial may receive, can reduce severe lung infections caused by RSV by about 58.8%, potentially preventing serious illness from the virus. Similarly, the RSV 6120/∆NS1 vaccine, another option in this trial, has effectively reduced significant lower respiratory infections related to RSV. Both vaccines use a weakened form of the virus to help the body learn to fight off real infections. Early research suggests these vaccines could protect children from severe RSV symptoms.13567
Who Is on the Research Team?
Ruth A. Karron, MD
Principal Investigator
Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health (JHSPH)
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of RSV 6120/∆NS1 or RSV 6120/F1/G2/∆NS1 vaccine or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
Post-RSV Season Follow-up
Participants in Group 2 are monitored for natural RSV infection and antibody responses
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- RSV 6120/F1/G2/∆NS1
- RSV 6120/∆NS1
Trial Overview
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.
How Is the Trial Designed?
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.
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.
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.
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
Citations
Current State and Challenges in Developing Respiratory ...
Moreover, it demonstrated 39.4% efficacy in reducing RSV-specific medically significant LRTI and 58.8% efficacy in reducing RSV-related severe ...
Study Details | NCT03596801 | Evaluating the Infectivity, ...
This study will evaluate the infectivity, safety, and immunogenicity of a single dose of recombinant, live-attenuated respiratory syncytial virus (RSV) vaccines ...
Respiratory Syncytial Virus Vaccine Design Using ...
The ∆NS1 virus had a reduced ability compared to RSV wt to delay apoptosis in A549 cells, as evidenced by higher signals than RSV wt at 12, 21, ...
Current strategies and perspectives for active and passive ...
The purpose of this review is to summarize available data on approved and developing passive and active immunizations against RSV in childhood and pregnancy.
RSV vaccines safe and effective, Cochrane review finds - ECDC
Results showed strong evidence that the RSV prefusion vaccines in older adults reduce RSV-associated lower respiratory tract disease such as ...
Respiratory Syncytial Virus (RSV) Vaccine Safety
Because of its recent introduction, post-licensure safety data are not yet available for this vaccine, which is currently being monitored in V- ...
Respiratory Syncytial Virus (RSV) Infection ...
A Study to Test GlaxoSmithKline's (GSK) Respiratory Syncytial Virus RSV Candidate Vaccine's Safety and Immune Response in Japanese Older Adults ... RSV 6120/∆NS1.
Other People Viewed
By Subject
By Trial
Related Searches
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.