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

A Randomized, Double-blind Phase 3 Study to Assess the Immunogenicity and Safety of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus Prevention
• Intervention / Treatment: Biological: Ad26.RSV.PreF-based Vaccine

• Study Type: Interventional
• Enrollment (Actual): 755
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Athens, Alabama, United States, 35611
      • North Alabama Research Center, LLC
    • Vestavia Hills, Alabama, United States, 35216
      • Achieve Clinical Research, LLC
  • Arizona
    • Phoenix, Arizona, United States, 85023
      • Hope Research Institute
  • Connecticut
    • Milford, Connecticut, United States, 06460
      • Clinical Research Consulting
  • Florida
    • DeLand, Florida, United States, 32720
      • Accel Research Sites
    • Miami, Florida, United States, 33135
      • Suncoast Research Group
    • Miami, Florida, United States, 33173
      • Suncoast Research Associates, LLC
    • Miami, Florida, United States, 33126
      • Pharmax Research Clinic Inc
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
  • Maryland
    • Elkridge, Maryland, United States, 21075
      • Centennial Medical Group
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Be Well Clinical Studies
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • American Health Network, LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • CTI Clinical Trial and Consulting Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Ad26.RSV.PreF-based Vaccine; 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; Ad26.RSV.PreF-based Vaccine will be administered as single IM injection.
Experimental: Group 2: Ad26.RSV.PreF-based Vaccine; 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; Ad26.RSV.PreF-based Vaccine will be administered as single IM injection.
Experimental: Group 3: Ad26.RSV.PreF-based Vaccine; 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; Ad26.RSV.PreF-based Vaccine will be administered as single IM injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days Post Vaccination	RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay at 14 days post administration of Ad26/protein preF RSV-based vaccine were expressed as 50 percent (%) inhibitory concentration (IC50) units.	14 days post vaccination on Day 1 (Day 15)
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days Post Vaccination	Number of participants with solicited local AEs 7 days post vaccination were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site).	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	Number of participants with solicited systemic AEs 7 days post vaccination were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic events include events such as fatigue, headache, nausea, myalgia, and pyrexia, for which participants were specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).	Up to Day 7 post vaccination on Day 1 (up to Day 8)
Number of Participants With Unsolicited AEs for 28 Days Post Vaccination	Number of participants with unsolicited AEs 28 days post vaccination were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary.	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	Number of participants with SAEs until 6 months post vaccination were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.	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	Number of participants with AESIs until 6 months post vaccination were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Thrombosis with thrombocytopenia syndrome (TTS) was considered as an AESI.	From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183)

Collaborators and Investigators

• Sponsor: Janssen Vaccines & Prevention B.V.
• Investigators: Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial, Janssen Vaccines & Prevention B.V.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): March 28, 2022
• Study Completion (Actual): September 20, 2022

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CR109069; 2021-002388-23 (EudraCT Number); VAC18193RSV3003 (Other Identifier: Janssen Vaccines & Prevention B.V.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No