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Virus Therapy

Ad26.RSV.preF-based Vaccine for Respiratory Syncytial Virus Infection

Phase 3
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 7 days after vaccination on day 1 (day 8)
Awards & highlights

Study Summary

This study is evaluating whether a vaccine can be safely given to adults 18 to 59 years of age.

Eligible Conditions
  • Respiratory Syncytial Virus Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days after vaccination on day 1 (day 8)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days after vaccination on day 1 (day 8) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Percentage of Participants With Seroresponse as Assessed by Virus Neutralizing Assay (VNA-A2)
Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers
Cohorts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs)
+4 more
Secondary outcome measures
Cohorts 1, 2, and 3: Geomteric Mean Titers (GMTs) of RSV Fusion Protein (F-protein) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)- Pre-Fusion

Side effects data

From 2022 Phase 3 trial • 1124 Patients • NCT05070546
19%
Chills
3%
Vomiting
3%
Night Sweats
3%
Covid-19
2%
Sinusitis
1%
Headache
1%
Upper Respiratory Tract Infection
1%
Diarrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 6 (Cohort 3): Placebo
Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein
Group 2 (Cohort 1): Placebo
Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein
Group 4 (Cohort 2): Placebo
Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF Protein

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort (C)1 Group (G)1: Healthy Adults, 18-59 Years (Respiratory Syncytial Virus [RSV] vaccine)Experimental Treatment1 Intervention
Participants will receive a single intramuscular (IM) injection of study vaccine on Day 1.
Group II: C3 G5: Adults, 65 Years and Older (RSV Vaccine)Experimental Treatment1 Intervention
Participants will receive a single IM injection of study vaccine on Day 1.
Group III: C2 G3: High Risk Adult, 18-59 Years (RSV Vaccine)Experimental Treatment1 Intervention
Participants will receive a single IM injection of study vaccine on Day 1.
Group IV: C1 G2: Healthy Adults, 18-59 Years (Placebo)Placebo Group1 Intervention
Participants will receive a single IM injection of matching placebo on Day 1.
Group V: C3 G6: Adults, 65 Years and Older (Placebo)Placebo Group1 Intervention
Participants will receive a single IM injection of matching placebo on Day 1.
Group VI: C2 G4: High Risk Adult, 18-59 Years (Placebo)Placebo Group1 Intervention
Participants will receive a single IM injection of matching placebo on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ad26.RSV.preF-based Vaccine
2021
Completed Phase 3
~1130

Find a Location

Who is running the clinical trial?

Janssen Vaccines & Prevention B.V.Lead Sponsor
55 Previous Clinical Trials
1,133,224 Total Patients Enrolled
Janssen Vaccines & Prevention B.V. Clinical TrialStudy DirectorJanssen Vaccines & Prevention B.V.
47 Previous Clinical Trials
134,432 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of an Ad26.RSV. preF-based Vaccine in Adults Aged 18 to 59 Years, Including Adults at High Risk for Severe RSV Infection
2021. "A Study of an Ad26.RSV. preF-based Vaccine in Adults Aged 18 to 59 Years, Including Adults at High Risk for Severe RSV Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05070546.
~321 spots leftby Apr 2025
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