A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years

NCT05101486 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: CR1090692021-002388-23VAC18193RSV3003
• Study Type: interventional
• Target: 755
• Locations: 1 country
• Sites: 13

Brief 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.

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 vaccine were reported.

  14 days post vaccination on Day 1 (Day 15)

Secondary Outcomes (6)

• Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days Post Vaccination

  14 days post vaccination on Day 1 (Day 15)

• 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 28 days 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)

Study Arms (3)

Group 1: Ad26.RSV.PreF-based Vaccine

EXPERIMENTAL

Participants will receive a single intramuscular (IM) injection of Ad26.RSV.PreF-based vaccine on Day 1 (non-aged lot).

Biological: Ad26.RSV.PreF-based Vaccine

Group 2: Ad26.RSV.PreF-based Vaccine

EXPERIMENTAL

Participants will receive a single IM injection of Ad26.RSV.PreF-based vaccine on Day 1 (aged lot 1).

Biological: Ad26.RSV.PreF-based Vaccine

Group 3: Ad26.RSV.PreF-based Vaccine

EXPERIMENTAL

Participants will receive a single IM injection of Ad26.RSV.PreF-based vaccine on Day 1 (aged lot 2).

Biological: Ad26.RSV.PreF-based Vaccine

Interventions

Ad26.RSV.PreF-based Vaccine BIOLOGICAL

Ad26.RSV.PreF-based Vaccine will be administered as single IM injection.

Group 1: Ad26.RSV.PreF-based Vaccine; Group 2: Ad26.RSV.PreF-based Vaccine; Group 3: Ad26.RSV.PreF-based Vaccine

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Janssen Vaccines & Prevention B.V.: lead

Study Sites (13)

North Alabama Research Center, LLC

Athens, Alabama, 35611, United States

Location

Achieve Clinical Research, LLC

Vestavia Hills, Alabama, 35216, United States

Location

Hope Research Institute

Phoenix, Arizona, 85023, United States

Location

Clinical Research Consulting

Milford, Connecticut, 06460, United States

Location

Accel Research Sites

DeLand, Florida, 32720, United States

Location

Pharmax Research Clinic Inc

Miami, Florida, 33126, United States

Location

Suncoast Research Group

Miami, Florida, 33135, United States

Location

Suncoast Research Associates, LLC

Miami, Florida, 33173, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Centennial Medical Group

Elkridge, Maryland, 21075, United States

Location

Be Well Clinical Studies

Lincoln, Nebraska, 68516, United States

Location

American Health Network, LLC

Charlotte, North Carolina, 28277, United States

Location

CTI Clinical Trial and Consulting Services

Cincinnati, Ohio, 45212, 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: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 1, 2021
• Study Start: November 1, 2021
• Primary Completion: March 28, 2022
• Study Completion: September 20, 2022
• Last Updated: May 25, 2025
• Results First Posted: September 6, 2023

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (13)