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RSV Vaccines for Respiratory Syncytial Virus

Phase 1 & 2
Waitlist Available
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
Has received routine immunizations appropriate for age (as per national Center for Disease Control Advisory Committee on Immunization Practices [ACIP]).
Seronegative for RSV antibody, defined as a serum RSV-neutralizing antibody titer less than 1:40 at screening from a sample collected no more than 42 days prior to study product administration.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured through the last day of the rsv season, which will occur between 5 and 12 months after study entry, depending on when the participant enrolls in the study
Awards & highlights

Study Summary

This trial will evaluate the safety and effectiveness of three different RSV vaccines in young children.

Who is the study for?
This trial is for healthy children aged 6 to 24 months who have not been exposed to RSV, as shown by a low antibody count. They should be growing normally and up-to-date with routine vaccinations. Children cannot participate if they've had RSV before, are immunocompromised, have serious congenital issues or heart disease, live with very young infants or certain other individuals at risk.Check my eligibility
What is being tested?
The study tests the safety and immune response of three different experimental nasal drop vaccines against Respiratory Syncytial Virus (RSV) compared to a placebo in toddlers who haven't encountered the virus before.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical vaccine-related side effects may include temporary discomfort at the administration site (nose), fever, irritability, runny nose or congestion. Serious side effects are rare but could involve allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am up to date with all vaccinations recommended for my age.
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My blood test shows I don't have enough antibodies to fight RSV.
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I am between 6 months and less than 25 months old.
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I was born to an HIV-infected mother and have tested negative for HIV.
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I am between 6 months and less than 25 months old.
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I am in good health with no chronic diseases.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured through the last day of the rsv season, which will occur between 5 and 12 months after study entry, depending on when the participant enrolls in the study
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured through the last day of the rsv season, which will occur between 5 and 12 months after study entry, depending on when the participant enrolls in the study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of Grade 1 or higher solicited adverse events (AEs)
Frequency of Grade 2 or higher lower respiratory illnesses (LRIs)
Antibodies, Blocking
+1 more
Secondary outcome measures
Frequency of RSV-associated medically attended acute lower respiratory illness (RSV-MAALRI)
Frequency of RSV-associated medically attended acute respiratory illness (RSV-MAARI)
Frequency of a greater than or equal to 4-fold rise in serum RSV F immunoglobulin G (IgG)
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: RSV ΔNS2/Δ1313/I1314L VaccineExperimental Treatment1 Intervention
Participants will receive a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine at study entry (Day 0).
Group II: RSV 6120/ΔNS2/1030s VaccineExperimental Treatment1 Intervention
Participants will receive a single dose of the RSV 6120/ΔNS2/1030s vaccine at study entry (Day 0).
Group III: RSV 276 VaccineExperimental Treatment1 Intervention
Participants will receive a single dose of the RSV 276 vaccine at study entry (Day 0).
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive a single dose of placebo at study entry (Day 0).

Find a Location

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
3,261 Previous Clinical Trials
5,482,939 Total Patients Enrolled
Coleen Cunningham, MDStudy ChairUniversity of California, Irvine
3 Previous Clinical Trials
165 Total Patients Enrolled
Ruth Karron, MDStudy ChairCenter for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health (JHSPH)
3 Previous Clinical Trials
35 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT03916185 — Phase 1 & 2
Respiratory Syncytial Virus Research Study Groups: RSV ΔNS2/Δ1313/I1314L Vaccine, RSV 6120/ΔNS2/1030s Vaccine, RSV 276 Vaccine, Placebo
Respiratory Syncytial Virus Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT03916185 — Phase 1 & 2
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT03916185 — Phase 1 & 2
Respiratory Syncytial Virus Patient Testimony for trial: Trial Name: NCT03916185 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this study limited to those aged 60 or under?

"This medical trial is recruiting patients aged between half a year and two years old. Additionally, there are 51 studies available to those under 18 while 88 exist for people over 65."

Answered by AI

In what Canadian sites is this investigation being conducted?

"Currently, 15 trial sites are operational. These include Aurora, Baltimore and Stony Brook with an additional 12 locations spread across the country. To reduce necessary travel for participation in this study it is wise to choose a site close to your home."

Answered by AI

What is the estimated participant count for this clinical trial?

"Correct. According to clinicaltrials.gov, this medical research project is presently in need of participants - first posted on May 16th 2019 and last updated November 21st 2022. 160 volunteers are needed across 15 trial sites."

Answered by AI

What are the chief aims of this investigation?

"The primary measure of this trial, judged on Day 56, is the rate of Grade 1 or higher adverse events. Secondary metrics include serum RSV F IgG titer (determined through immunologic assessment), maximum grade of RSV-MAALRI illness (following a protocol-defined grading system for solicited events) and frequency of medically attended acute lower respiratory illnesses associated with RSV (also graded according to the same criteria)."

Answered by AI

For which demographic is this research endeavor suitable?

"For inclusion in this study, applicants must have been diagnosed with Respiratory Syncytial Virus and be between 6 to 25 months of age. This trial has a designated recruitment number of 160 participants."

Answered by AI

Are there any volunteers being admitted to this research project currently?

"This clinical investigation, which was first published on May 16th 2019, is currently enrolling participants. The listing has been updated most recently on November 21st 2022."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What site did they apply to?
Emory University School of Medicine NICHD CRS
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I am happy to play my part in the research of new products.
PatientReceived no prior treatments
~11 spots leftby Mar 2025