A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Aged 60 - 75 Years Old

NCT05083585 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CR109065VAC18193RSV3004
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses induced by vaccination with one dose of the Phase 3 clinical trial material (CTM) compared with one dose of the Phase 2b CTM.

Conditions

Respiratory Syncytial Virus Prevention

Outcome Measures

Primary Outcomes (1)

• Geometric Mean Titers (GMTs) of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) 14 Days Post Vaccination

  GMTs of pre-F antibodies as assessed by ELISA at 14 days post administration of Ad26/protein preF RSV based vaccine were reported.

  14 days post vaccination on Day 1 (Day 15)

Secondary Outcomes (6)

• Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days Post Vaccination

  Up to Day 7 post vaccination on Day 1 (up to Day 8)

• Number of Participants With Solicited Systemic AEs for 7 Days Post Vaccination

  Up to Day 7 post vaccination on Day 1 (up to Day 8)

• Number of Participants With Unsolicited AEs for 28 Days Post Vaccination

  Up to Day 28 post vaccination on Day 1 (up to Day 29)

• Number of Participants With Serious Adverse Events (SAEs) Until 6 Months Post Vaccination

  From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183)

• Number of Participants With Adverse Event of Special Interests (AESIs) Until 6 Months Post Vaccination

  From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183)

Study Arms (2)

Group 1: Phase 3 Clinical Trial Material (CTM)

EXPERIMENTAL

Participants will receive a single intramuscular (IM) injection of adenovirus serotype 26 (Ad26). respiratory syncytial virus (RSV). prefusion conformation-stabilized F protein (preF)-based vaccine on Day 1, which is a Phase 3 CTM.

Biological: Ad26.RSV.preF-based vaccine

Group 2: Phase 2b CTM

EXPERIMENTAL

Participants will receive a single IM injection of Ad26.RSV.preF-based vaccine on Day 1, which is a Phase 2b CTM.

Biological: Ad26.RSV.preF-based vaccine

Interventions

Ad26.RSV.preF-based vaccine BIOLOGICAL

Ad26.RSV.preF-based vaccine will be administered as a single intramuscular injection.

Group 1: Phase 3 Clinical Trial Material (CTM); Group 2: Phase 2b CTM

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to adhere to the prohibitions and restrictions specified in the protocol
• Before randomization, a participant must be postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and not intending to conceive by any methods
• In the investigator's clinical judgment, 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 willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
• From the time of vaccination through 3 months after vaccination, agrees not to donate blood

You may not qualify if:

• 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 condition or medication
• History of acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy
• History of thrombosis with thrombocytopenia syndrome (TTS) or heparin-induced thrombocytopenia and thrombosis (HITT)
• 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

Sponsors & Collaborators

• Janssen Vaccines & Prevention B.V.: lead

Study Sites (9)

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Optimal Research

San Diego, California, 92108, United States

Location

Accel Research Sites

Lakeland, Florida, 33803, United States

Location

Optimal Research

Melbourne, Florida, 32934, United States

Location

Pharmax Research Clinic Inc

Miami, Florida, 33126, United States

Location

Research Institute of South Florida Inc

Miami, Florida, 33173, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Meridian Clinical Research, LLC

Cincinnati, Ohio, 45219, United States

Location

Tekton Research Inc.

San Antonio, Texas, 78229, United States

Location

Results Point of Contact

• Title: Director Biomarkers Viral Vaccines
• Organization: Janssen Vaccines & Prevention B.V.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Vaccines & Prevention B.V. Clinical Trial

  Janssen Vaccines & Prevention B.V.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 19, 2021
• Study Start: October 8, 2021
• Primary Completion: March 7, 2022
• Study Completion: September 22, 2022
• Last Updated: May 25, 2025
• Results First Posted: September 11, 2023

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (9)