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Virus Therapy
RSV Vaccines for Respiratory Syncytial Virus
Phase 1
Recruiting
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
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
Awards & highlights
Study Summary
This trial will study the effects of two different RSV vaccines in children who are either RSV-positive or RSV-negative. The goal is to see if the vaccines are safe and effective.
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.Check my eligibility
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.See study design
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 belowSelect...
My growth is normal for my age, with height and weight above the 3rd percentile.
Select...
I am between 1 and 5 years old.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreTrial 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.
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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
3,269 Previous Clinical Trials
5,481,394 Total Patients Enrolled
Ruth A. Karron, MDPrincipal InvestigatorCenter for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health (JHSPH)
19 Previous Clinical Trials
893 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am receiving treatment for a heart condition.I have had wheezing or used a bronchodilator in the last year.My growth is normal for my age, with height and weight above the 3rd percentile.I have a long-term illness.I have received a bone marrow or organ transplant.I have had wheezing or used inhalers after turning 1 year old.My overall health is good as confirmed by my recent medical records and physical exam.I am up to date with all vaccinations recommended for my age.I have a lung condition or asthma.I have not received immunoglobulin or antibody treatments in the last 6 months.I have not received any blood products in the last 6 months.I had a severe reaction to a vaccine before.I currently have a fever, upper respiratory symptoms, or severe nasal congestion.I am between 1 and 5 years old.I have received or will receive treatment for RSV with specific medications.I live with someone who has a weakened immune system or will be around young children in a daycare.I haven't had any vaccines or taken aspirin in the last 28 days.I am not scheduled to receive certain vaccines or investigational drugs soon after the planned treatment.I haven't taken antibiotics, antivirals, antifungals, anti-parasitics, or certain other meds in the last 3 days.I do not have major birth defects like cleft palate or genetic abnormalities.I have used supplemental oxygen at home before.I live with a baby under 12 months old.I have had more than one wheezing episode in my first year.
Awards:
This trial has 0 awards, including:Research Study Groups:
This trial has the following groups:- Group 1: Group 1: RSV 6120/F1/G2/∆NS1 Vaccine
- Group 2: Group 2: Placebo
- Group 3: Group 2: RSV 6120/∆NS1 Vaccine
- Group 4: Group 1: Placebo
- Group 5: Group 2: RSV 6120/F1/G2/∆NS1
- Group 6: Group 1: RSV 6120/∆NS1 Vaccine
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research study afford me the opportunity to participate?
"This study seeks 75 children between 6 and 59 months of age with a pre-existing infection of respiratory syncytial virus. To be accepted, applicants must have entered their first year of life but not yet reached the 5th birthday mark; maintain general health as determined by medical history, physical exam, and record review; and remain available for the duration of the trial."
Answered by AI
What health risks might be associated with RSV 6120/F1/G2/∆NS1?
"As this is a Phase 1 trial, and thus lacks data regarding safety and efficacy, RSV 6120/F1/G2/∆NS1 obtained a score of one on our team's internal scale."
Answered by AI
What is the ultimate aim of this research initiative?
"The primary experiment that will be carried out and measured at Day 56 is the duration of virus shedding in nasal washes among seronegative participants. Secondary outcomes comprise frequency of antibody responses, rate of symptomatic illness, and measurement mucosal antibodies titers to the vaccine administered based on laboratory evaluations."
Answered by AI
Does the current research initiative accept new participants?
"According to clinicaltrials.gov, this trial is not recruiting patients currently; it was initially posted on June 25th 2018 and last updated on February 8th 2022. Despite the inactivity of this particular study, 33 other trials are actively seeking participants at present."
Answered by AI
Are participants aged over 40 years eligible for this scientific investigation?
"This trial mandates that participants are between 6 and 59 months of age, as detailed in the requirements for inclusion."
Answered by AI
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