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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial will evaluate the safety and immune response of a RSV vaccine in three groups: children who have had RSV, those who have not, and younger infants who have not been screened.

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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency and severity of vaccine-related solicited adverse events (AEs) that occur during the intensive monitoring phase of the study

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 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 VI: 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 VII: 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 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 / 1Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Johns Hopkins Bloomberg School of Public HealthOTHER

410 Previous Clinical Trials

2,116,842 Total Patients Enrolled

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,269 Previous Clinical Trials

5,481,381 Total Patients Enrolled

Ruth A. Karron, MDPrincipal InvestigatorJohns Hopkins Bloomberg School of Public Health

19 Previous Clinical Trials

880 Total Patients Enrolled

Media Library

Respiratory Syncytial Virus Research Study Groups: Group 4: RSV vaccine, Group 2: Placebo, Group 3: RSV vaccine, Group 3: Placebo, Group 4: Placebo, Group 1: RSV vaccine, Group 1: Placebo, Group 2: RSV vaccine

Frequently Asked Questions

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

Does the research include geriatrics as participants?

"The participant selection criteria of this medical trial requires that potential recruits are aged between 4 and 59 months."

Answered by AI

Are enrollees still being accepted for this medical experiment?

"Affirmative. Data from clinicaltrials.gov verifies that this research is currently seeking participants, with the trial first published on June 1st 2013 and most recently revised on August 31 2021. The recruitment process will entail 105 individuals at two distinct facilities."

Answered by AI

How many individuals are eligible for inclusion in this clinical trial?

"Affirmative. Data hosted on clinicaltrials.gov suggests that this medical investigation is actively searching for participants at the moment; it was first posted on June 1st 2013 and modified lastly on August 31st 2021. A total of 105 patients need to be enrolled from 2 distinct sites."

Answered by AI

Is enrollment in this experiment still open to the public?

"This trial seeks 105 volunteers aged between 4 months and 59 months old with respiratory syncytial virus infections. To be eligible, participants must meet these criteria."

Answered by AI

What risks are associated with the RSV ΔNS2 Δ1313 I1314L Vaccine?

"Clinical data on RSV ΔNS2 Δ1313 I1314L Vaccine is limited, prompting the Power team to assign it a safety score of 1. As this trial is in Phase 1, efficacy and safety have not been established yet."

Answered by AI

Recent research and studies

The Journal of Infectious DiseasesJournal

Safety and Immunogenicity of the Respiratory Syncytial Virus Vaccine RSV/ΔNS2/Δ1313/I1314L in Rsv-seronegative Children

Karron, Ruth A, Cindy Luongo, Jocelyn San Mateo, Kimberli Wanionek, Peter L Collins, and Ursula J Buchholz. 2019. “Safety and Immunogenicity of the Respiratory Syncytial Virus Vaccine RSV/ΔNS2/Δ1313/I1314L in Rsv-seronegative Children”. The Journal of Infectious Diseases. Oxford University Press (OUP). doi:10.1093/infdis/jiz408.

clinicaltrials.govStudy

Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in Infants and Children

2013. "Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in Infants and Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01893554.

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