Phase 3 N=25,236 Randomized Double-blind Prevention

A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older

Respiratory Syncytial Viruses · Lower Respiratory Tract Disease

Bottom Line

View on ClinicalTrials.gov: NCT04908683 ↗

Enrolled (actual)

25,236

Serious AEs

5.2%

Results posted

Feb 2024

Primary outcome: Primary: Number of Participants With First Occurrence of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV) Mediated Lower Respiratory Tract Disease (LRTD) — 44; 63 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF (Biological); Placebo (Biological)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: Janssen Vaccines & Prevention B.V.
Primary completion: Jul 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With First Occurrence of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV) Mediated Lower Respiratory Tract Disease (LRTD)	44; 63	—
SECONDARY Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV-mediated Acute Respiratory Infection (ARI)	77; 101	—
SECONDARY Number of Participants With First Occurrence of RT-PCR-Confirmed RSV Mediated LRTD During the Second Year	16; 29	—
SECONDARY Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV Mediated ARI During the Second Year	39; 44	—
SECONDARY Number of Participants With First Occurrence of Predefined Clinically Relevant Disease Associated With RT-PCR-Confirmed RSV-Mediated ARI Over the Whole Study	4; 11	—
SECONDARY Number of Participants With Serious Adverse Events (SAEs)	119; 53; 446; 239	—
SECONDARY Number of Participants With Potential Adverse Events of Special Interest (AESIs)	25; 4; 71; 35	—
SECONDARY Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Vaccination	1076; 169	—
SECONDARY Number of Participants With Solicited Systemic AEs up to 7 Days After Vaccination	1018; 236	—
SECONDARY Number of Participants With Unsolicited AEs up to 28 Days After Vaccination	554; 206	—
SECONDARY Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at 14 Days Post Vaccination	7194; 537	—
SECONDARY Geometric Mean Titers (GMTs) of Prefusion F-protein (Pre-F) Antibodies Immunoglobulin G (IgG) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days Post Vaccination	4932; 410	—
SECONDARY T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides Analyzed by Enzyme-linked Immunospot Assay (ELISpot)	533; NA	—
SECONDARY Area Under the Curve (AUC) of the Change From Baseline in Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Total Symptom Scale Score	82; 107	—

Summary

The study will enroll up to 27,200 participants in order to demonstrate the efficacy of the active Ad26.RSV.preF-based study vaccine in the prevention of Reverse Transcription Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV)-mediated Lower Respiratory Tract Disease (LRTD) when compared to placebo in adults aged 60 years and above.

Eligibility Criteria

Inclusion Criteria

Must be able to work with smartphones/tablets/computers
From the time of vaccination through 3 months after vaccination, participant agrees not to donate blood
Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
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
Participants must sign an Inform Consent Form (ICF) indicating that the participant understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study

Exclusion Criteria

Has a serious clinically unstable condition, (example, end-stage renal disease with or without dialysis, clinically unstable cardiac disease), Alzheimer's disease, or any other condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise well-being) or that could prevent, confound, or limit the protocol specified assessments
History of malignancy within 5 years before screening not in the following categories: a. Participants with squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix may be enrolled at the discretion of the investigator; b. Participants with a history of malignancy within 5 years, which is considered cured with minimal risk of recurrence per investigator's judgement, can be enrolled
Had major surgery (example, major cardiopulmonary or abdominal operations) as per the investigator's judgment within 4 weeks before vaccination, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study
Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator, or an employee of the sponsor
Contraindication to Intramuscular (IM) injections and blood draws (example, bleeding disorders)
Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04908683). 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.