Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF for Lower Respiratory Tract Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Lower Respiratory Tract Disease+2 More
Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will enroll up to 27,500 people to see if the study vaccine prevents RSV-mediated Lower Respiratory Tract Disease (LRTD) better than placebo in adults aged 60 years and above.

Eligible Conditions
  • Lower Respiratory Tract Disease
  • Respiratory syncytial virus

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 20 Secondary · Reporting Duration: From Month 12 to Month 24

Day 29
Percentage of Participants with Unsolicited AEs
Day 8
Percentage of Participants with Solicited Local Adverse Events (AEs)
Percentage of Participants with Solicited Systemic AEs
Month 24
Area Under the Curve (AUC) of the Change from Baseline in Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Total Symptom Scale Score
Month 24
Percentage of Participants with RT-PCR Confirmed RSV-mediated Lower Respiratory Tract Disease (LRTD) During the Second Year
Percentage of participants with RT-PCR Confirmed RSV-mediated ARI During the Second Year
Up to 21 months
Percentage of Participants with RT-PCR Confirmed RSV-mediated Acute Respiratory Infection (ARI) Over the Whole Study
Percentage of Participants with RT-PCR Confirmed RSV-mediated LRTD Over the Whole Study
Percentage of Participants with predefined clinically relevant disease associated with RT-PCR-confirmed RSV-mediated ARI Over the Whole Study
Percentage of participants with RT-PCR Confirmed RSV-mediated ARI during the Second RSV Season
RSV preF and postF Protein Binding Antibodies by Enzyme-linked Immunosorbent Assay (ELISA)
Up to 24 months
Interferon Gamma (IFN-gamma) Enzyme-Linked Immunospot (ELISpot) Assay
Percentage of Participants with Predefined Clinically Relevant Disease Associated with RT-PCR-confirmed RSV-mediated ARI Over the Whole Study
Percentage of Participants with RT-PCR Confirmed RSV-mediated Acute Respiratory Infection (ARI)
Percentage of Participants with Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV) mediated Lower Respiratory Tract Disease (LRTD)
RSV Neutralizing Antibody Levels
RSV preF and/or postF Protein Binding Antibodies by Enzyme-linked Immunosorbent Assay (ELISA)
Up to 6 months
Percentage of Participants with Adverse Events of Special Interest (AESIs)
Percentage of Participants with Serious Adverse Events (SAEs)
Up to 9 months
Percentage of Participants with RT-PCR Confirmed RSV-mediated Acute Respiratory Infection (ARI) During the First RSV Season
Month 21
Percentage of Participants with RT-PCR Confirmed RSV-mediated Lower Respiratory Tract Disease (LRTD) during the Second RSV Season

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Group 1: Respiratory Syncytial Virus (RSV) vaccine
1 of 2
Group 2: Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

27200 Total Participants · 2 Treatment Groups

Primary Treatment: Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF · Has Placebo Group · Phase 3

Group 1: Respiratory Syncytial Virus (RSV) vaccineExperimental Group · 2 Interventions: Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF, Placebo · Intervention Types: Biological, Biological
Group 2: Placebo
Biological
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from month 12 to month 24

Who is running the clinical trial?

Janssen Vaccines & Prevention B.V.Lead Sponsor
52 Previous Clinical Trials
1,110,029 Total Patients Enrolled
Janssen Vaccines & Prevention B.V. Clinical TrialStudy DirectorJanssen Vaccines & Prevention B.V.
46 Previous Clinical Trials
111,210 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to work with smartphones/tablets/computers.
You are a postmenopausal woman and you are not intending to conceive by any methods.
You must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study.
You must sign an Inform Consent Form (ICF) indicating that you understand the purpose, procedures and potential risks and benefits of the study, and are willing to participate in the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: November 7th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Texas40.0%
Florida20.0%
North Carolina10.0%
Other30.0%
How old are they?
18 - 6587.5%
65+12.5%
What site did they apply to?
Compass Research LLC14.3%
MedPharmics - Biloxi14.3%
Tekton Research Inc.28.6%
Other42.9%
What portion of applicants met pre-screening criteria?
Did not meet criteria22.2%
Met criteria77.8%
Why did patients apply to this trial?
  • "Have a history of upper respiratory illness due to asthma & allergies. RSV is on the rise. i would like to avoid getting it."
How many prior treatments have patients received?
0100.0%

How responsive is this trial?

Typically responds via
Email100.0%