Phase 3
N=755
A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years
Respiratory Syncytial Virus Prevention
Bottom Line
View on ClinicalTrials.gov: NCT05101486 ↗Enrolled (actual)
755
Serious AEs
2.1%
Results posted
Sep 2023
Primary outcome: Primary: Geometric Mean Titers (GMTs) of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) 14 Days Post Vaccination — 4277; 4121; 4602 ELISA units per liter (EU/L)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ad26.RSV.PreF-based Vaccine (Biological)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Janssen Vaccines & Prevention B.V.
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titers (GMTs) of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) 14 Days Post Vaccination |
4277; 4121; 4602 | — |
| SECONDARY Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days Post Vaccination |
6516; 5538; 6846 | — |
| SECONDARY Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days Post Vaccination |
119; 103; 81 | — |
| SECONDARY Number of Participants With Solicited Systemic AEs for 7 Days Post Vaccination |
101; 86; 65 | — |
| SECONDARY Number of Participants With Unsolicited AEs for 28 Days Post Vaccination |
22; 16; 15 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) Until 6 Months Post Vaccination |
5; 4; 7 | — |
| SECONDARY Number of Participants With Adverse Event of Special Interests (AESIs) Until 6 Months Post Vaccination |
0; 0; 0 | — |
Summary
The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses of Ad26.RSV.preF-based study vaccine lots representative of different aged vaccine in comparison to a non-aged Ad26.RSV.preF-based study vaccine lot.
Eligibility Criteria
Inclusion Criteria
- Before randomization, a participant must be: a) postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and b) not intending to conceive by any methods
- From the time of vaccination through 3 months after vaccination, agrees not to donate blood
- In the investigator's clinical judgment, a participant must be in stable health at the time of vaccination. Participants may have underlying illnesses such as hypertension, congestive heart failure, chronic obstructive pulmonary disease, 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. Participants will be included on the basis of medical history and vital signs performed between informed consent form (ICF) signature and vaccination
- Must be able to read, understand, and complete questionnaires in the electronic diary (eDiary)
- Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
- Must be able to work with smartphones/tablets/computers
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 the immune system resulting from clinical conditions or medication
- Per medical history, participant has chronic active hepatitis B or hepatitis C infection
- History of acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy
- Has had major surgery (per the investigator's judgment) within 4 weeks before administration of the study vaccine or will not have recovered from surgery per the investigator's judgment at time of vaccination
- Has had major psychiatric illness and/or drug or alcohol abuse which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures
Data sourced from ClinicalTrials.gov (NCT05101486). 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.