Phase 3
N=1,124
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
Respiratory Syncytial Virus Infection Prevention
Bottom Line
View on ClinicalTrials.gov: NCT05070546 ↗Enrolled (actual)
1,124
Serious AEs
2.3%
Results posted
Oct 2023
Primary outcome: Primary: Cohorts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) — 273; 10; 276; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ad26.RSV.preF-based Vaccine (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Vaccines & Prevention B.V.
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cohorts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) |
273; 10; 276; 15 | — |
| PRIMARY Cohorts 1 and 2: Number of Participants With Solicited Systemic AEs |
277; 33; 275; 40 | — |
| PRIMARY Cohorts 1 and 2: Number of Participants With Unsolicited AEs |
111; 13; 85; 12 | — |
| PRIMARY Cohorts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs) |
1; 1; 10; 0; 13; 1 | — |
| PRIMARY Cohorts 1, 2, and 3: Number of Participants With Adverse Events of Special Interest (AESI) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers |
7095; 4596; 6491 | — |
| PRIMARY Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Percentage of Participants With Seroresponse as Assessed by Virus Neutralizing Assay (VNA-A2) |
88; 82.41; 89.37 | — |
| SECONDARY 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 |
4662; 246; 5175; 283; 3864; 240 | — |
Summary
The purpose of the study is to investigate the safety and immunogenicity of the Ad26.RSV.preF based vaccine in adults 18 to 59 years of age who are healthy or at risk for severe Respiratory Syncytial Virus (RSV) disease, compared to adults 65 years and above.
Eligibility Criteria
Inclusion Criteria
- Participants must be of a) non child bearing potential or b) of child bearing potential and practicing an acceptable and effective of contraception
- All participants of childbearing potential must: have a negative highly sensitive urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening; and have a negative highly sensitive urine beta-hCG pregnancy test immediately prior to each study vaccination (if screening and vaccination are not performed on the same day) Cohorts 1 and 2
- Participant is aged 18 to 59 years (inclusive) on the day of signing the informed consent form (ICF) and expected to be available for the duration of the study Cohort 2
- Has an existing chronic heart or lung condition, without hospitalizations or major medication class change (that is, new or stopped medications) within 30 days prior to screening, meeting the following criteria; a) cardiac disease: at least Class II symptoms per New York Heart Association classification or similar guidelines according to local practice, b) pulmonary disease: activity-restricting symptoms or use of long-term medications Cohort 3
- Participant is aged 65 years or older on the day of signing the ICF and expected to be available for the duration of the study
- Participant may have underlying illnesses such as hypertension, congestive heart failure, chronic obstructive pulmonary disease (COPD), type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are stable at the time of vaccination, and these conditions receive routine follow-up by the participant's healthcare provider
Exclusion Criteria
- Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
- Abnormal function of immune system due to a clinical condition or treatment
- History of thrombosis with thrombocytopenia syndrome (TTS) or heparin-induced thrombocytopenia and thrombosis (HITT).
- Participant received or plans to receive: (a) licensed live attenuated vaccines - within 28 days before or after planned administration of study vaccine; and (b) other licensed (not live) vaccines - within 14 days before or after planned administration of study vaccine
- Received an respiratory syncytial virus (RSV) vaccine in a previous RSV vaccine study
- History of acute polyneuropathy (example, Guillain-Barre syndrome) or chronic idiopathic demyelinating polyneuropathy
Data sourced from ClinicalTrials.gov (NCT05070546). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.