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Virus Therapy

RSV preF-based Vaccine for Lower Respiratory Tract Disease Prevention

Phase 1 & 2
Waitlist Available
Research Sponsored by Janssen Vaccines & Prevention B.V.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 up to 6 months post vaccination (up to day 183)
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a vaccine for RSV, a virus that causes respiratory illness, in people aged 60 and up.

Eligible Conditions
  • Respiratory Syncytial Virus-associated Lower Respiratory Tract Disease Prevention

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 days after vaccination on day 1 (up to day 29) and up to 28 days after re-vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days after vaccination on day 1 (up to day 29) and up to 28 days after re-vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Adverse Events of Special Interest (AESIs)
Number of Participants With Serious Adverse Events (SAEs)
Number of Participants With Solicited Local and Systemic Adverse Events (AEs)
+1 more
Secondary outcome measures
Cohort 2: Interferon Gamma (IFN-gamma) Enzyme-Linked Immunospot (ELISpot) Assay
Cohort 2: RSV Fusion Protein (F Protein) Binding Antibodies as Assessed by Enzyme-Linked Immunosorbent assay (ELISA)
Cohort 3: Respiratory Syncytial Virus (RSV) Neutralizing Antibody Levels
+5 more

Trial Design

19Treatment groups
Experimental Treatment
Group I: Arm 9: RSV preF Based VaccineExperimental Treatment1 Intervention
Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 4) and C 2 through intramuscular injection on Day 1.
Group II: Arm 8: RSV preF Based VaccineExperimental Treatment1 Intervention
Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 3) and C 2 through intramuscular injection on Day 1.
Group III: Arm 7: RSV preF Based VaccineExperimental Treatment1 Intervention
Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 3) and C 2 through intramuscular injection on Day 1.
Group IV: Arm 6: RSV preF Based VaccineExperimental Treatment1 Intervention
Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 2) and C 2 through intramuscular injection on Day 1.
Group V: Arm 5: RSV preF Based VaccineExperimental Treatment1 Intervention
Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 2) and C 2 through intramuscular injection on Day 1.
Group VI: Arm 4: RSV preF Based VaccineExperimental Treatment1 Intervention
Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 2) and C 2 through intramuscular injection on Day 1.
Group VII: Arm 3: RSV preF Based VaccineExperimental Treatment1 Intervention
Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 2) and C 2 through intramuscular injection on Day 1.
Group VIII: Arm 2: RSV preF Based VaccineExperimental Treatment1 Intervention
Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 2) and C 2 through intramuscular injection on Day 1.
Group IX: Arm 1c: PlaceboExperimental Treatment1 Intervention
Participants will receive single dose of placebo in C 1 (G 1-4) and C 2 through intramuscular injection on Day 1.
Group X: Arm 1b: RSV preF Based VaccineExperimental Treatment1 Intervention
Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 1-4) and C 2 through intramuscular injection on Day 1.
Group XI: Arm 1a: Respiratory Syncytial Virus (RSV) preFusion (preF) Based VaccineExperimental Treatment1 Intervention
Participants will receive single dose of mixture of RSV preF-based vaccine in cohort (C) 1 (Group [G] 1) and C 2 through intramuscular injection on Day 1.
Group XII: Arm 16: RSV preF Based Vaccine and PlaceboExperimental Treatment2 Interventions
Participants in C 4 will receive first vaccination with placebo on Day 1 and re-vaccination with selected formulation (as per data from C 1 and 2) whenever revaccination would be needed through intramuscular injection.
Group XIII: Arm 15: RSV preF Based Vaccine and PlaceboExperimental Treatment2 Interventions
Participants in C 4 will receive first vaccination with selected formulation (as per data from C 1 and 2) on Day 1 and re-vaccination with placebo whenever revaccination would be needed through intramuscular injection.
Group XIV: Arm 14: RSV preF Based VaccineExperimental Treatment1 Intervention
Participants in C 4 will receive first vaccination with selected formulation (as per data from C 1 and 2) on Day 1 and re-vaccination with selected formulation whenever revaccination would be needed through intramuscular injection.
Group XV: Arm 13: RSV preF Based VaccineExperimental Treatment2 Interventions
Participants in C 3 will receive the mixture of RSV preF-based vaccine plus placebo on Day 1 through intramuscular injection.
Group XVI: Arm 12: RSV preF Based Vaccine and PlaceboExperimental Treatment2 Interventions
Participants in C 3 will receive first vaccination with placebo on Day 1 and re-vaccination with selected formulation (as per data from C 1 and 2) whenever revaccination would be needed through intramuscular injection.
Group XVII: Arm 11b: RSV preF Based Vaccine and PlaceboExperimental Treatment2 Interventions
Participants in C 3 will receive a single dose of first vaccination with selected formulation (as per data from C 1 and 2) plus placebo on Day 1 and re-vaccination with placebo whenever revaccination would be needed through intramuscular injection.
Group XVIII: Arm 11a: RSV preF Based Vaccine and PlaceboExperimental Treatment2 Interventions
Participants in C 3 will receive a single dose of first vaccination with selected formulation (as per data C1 and 2) plus placebo on Day 1 and re-vaccination with selected formulation whenever revaccination would be needed through intramuscular injection.
Group XIX: Arm 10: RSV preF Based VaccineExperimental Treatment1 Intervention
Participants will receive a single dose of selected formulation (based on C 1 and 2 results) in C 3 through intramuscular injection on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Janssen Vaccines & Prevention B.V.Lead Sponsor
55 Previous Clinical Trials
1,134,216 Total Patients Enrolled
Janssen Vaccines & Prevention B.V. Clinical TrialStudy DirectorJanssen Vaccines & Prevention B.V.
47 Previous Clinical Trials
135,424 Total Patients Enrolled

Frequently Asked Questions

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

How many locations are participating in this empirical study?

"This research is being executed at 11 distinct sites, from Knoxville and Austin to Long Beach. To minimise transport needs during the study, participants should choose a medical centre near them for participation."

Answered by AI

Is enrollment for this research project open?

"Data on clinicaltrials.gov verifies that this trial is actively searching for participants, which was first posted on April 13th 2022 and has since received updates as recent as November 22nd 2022."

Answered by AI

What are the core aims of this clinical trial?

"The primary measurement of this trial, which will take place over the course of six months post-vaccination (up to day 181), is Cohort 3's Percentage of Participants with AESI. There are also secondary outcomes such as an IFN-gamma ELISpot assay measuring T-cell responses to RSV F protein peptides, a count of patients experiencing AESIs and Serious Adverse Events (SAEs) including death, hospitalization or disability related to the medication."

Answered by AI

To what extent has this clinical trial been populated with participants?

"Correct. According to information available on clinicaltrials.gov, this medical trial is still recruiting and was first made public April 13th 2022. As of November 22nd 2022, 1600 individuals are needed from 11 different sites for the research project."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Tekton Research Inc.
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

Is this an Mrna vaccine?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

i have asthma & allergies. Interested in minimizing if not prevent contracting RSV.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of Various Respiratory Syncytial Virus (RSV) Pre-Fusion (preF)-Based Vaccine Formulations in Adults Aged 60 Years and Older
2022. "A Study of Various Respiratory Syncytial Virus (RSV) Pre-Fusion (preF)-Based Vaccine Formulations in Adults Aged 60 Years and Older". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05327816.
~44 spots leftby Apr 2025
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