RSV Vaccine for Respiratory Syncytial Virus
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, certain medications like systemic steroids or recent vaccines may affect eligibility, so it's best to discuss your specific situation with the study team.
Is the RSV ΔNS2 Δ1313 I1314L Vaccine safe for humans?
How is the RSV ΔNS2 Δ1313 I1314L vaccine different from other RSV treatments?
The RSV ΔNS2 Δ1313 I1314L vaccine is unique because it is a live vaccine that has been genetically modified to be less harmful by deleting certain genes, making it temperature-sensitive and stable. This approach is different from current prevention methods, which rely on hygiene and expensive antibodies for high-risk children.12678
What data supports the effectiveness of the RSV ΔNS2 Δ1313 I1314L Vaccine treatment for Respiratory Syncytial Virus?
The research highlights promising vaccine candidates for RSV, including those with similar genetic modifications like the deletion of the NS2 gene, which have shown potential in inducing protective immunity in children. This suggests that the RSV ΔNS2 Δ1313 I1314L Vaccine may also be effective in preventing RSV-related illnesses.146910
Who Is on the Research Team?
Ruth A. Karron, MD
Principal Investigator
Johns Hopkins Bloomberg School of Public Health
Are You a Good Fit for This Trial?
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.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 the RSV vaccine or placebo administered as nose drops
Initial Follow-up
Participants are actively monitored for safety and immune response, including medical history reviews, clinical assessments, and nasal washes
Extended Follow-up
Parents or guardians monitor participants for RSV-associated illnesses and report weekly; additional study visits may occur
Long-term Follow-up
Participants in Groups 3 and 4 have the option for additional monitoring for a second RSV season
What Are the Treatments Tested in This Trial?
Interventions
- RSV ΔNS2 Δ1313 I1314L Vaccine
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborator