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History of Changes for Study: NCT03982199
A Study of an Ad26.RSV.preF-based Regimen in the Prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV)-Mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older
Latest version (submitted May 7, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 10, 2019 None (earliest Version on record)
2 July 9, 2019 Study Status, Contacts/Locations and Oversight
3 September 2, 2019 Recruitment Status, Study Status and Contacts/Locations
4 September 30, 2019 Contacts/Locations and Study Status
5 November 26, 2019 Contacts/Locations and Study Status
6 December 23, 2019 Contacts/Locations and Study Status
7 January 21, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
8 February 18, 2020 Study Status and Study Design
9 April 13, 2020 Study Status and Outcome Measures
10 May 12, 2020 Study Status
11 June 19, 2020 Outcome Measures, Arms and Interventions, Study Status and Study Design
12 July 7, 2020 Study Status and Study Design
13 August 4, 2020 Study Status and Study Design
14 September 23, 2020 Arms and Interventions and Study Status
15 October 27, 2020 Study Status and Study Design
16 November 24, 2020 Study Status
17 December 22, 2020 Study Status
18 March 5, 2021 Study Status, Outcome Measures, Arms and Interventions, Eligibility and Study Identification
19 June 25, 2021 Outcome Measures and Study Status
20 July 6, 2021 Study Status
21 August 3, 2021 Study Status
22 August 31, 2021 Study Status
23 October 26, 2021 Study Status
24 November 23, 2021 Study Status
25 December 21, 2021 Study Status
26 January 18, 2022 Study Status
27 February 15, 2022 Study Status
28 March 15, 2022 Study Status
29 April 12, 2022 Study Status
30 May 10, 2022 Study Status
31 June 7, 2022 Study Status
32 August 2, 2022 Study Status
33 August 30, 2022 Study Status
34 September 27, 2022 Study Status
35 October 25, 2022 Study Status
36 November 22, 2022 Study Status
37 December 20, 2022 Study Status
38 January 17, 2023 Study Status
39 February 14, 2023 Study Status
40 March 14, 2023 Study Status
41 May 10, 2023 Study Status
42 June 6, 2023
Quality Control Review has not concluded Returned: June 27, 2023
Recruitment Status, Study Status, Outcome Measures, Arms and Interventions, Document Section
43 June 28, 2023
Quality Control Review has not concluded Returned: June 28, 2023
Study Status
44 July 21, 2023 Study Status, Document Section, Adverse Events, Outcome Measures
45 May 7, 2024 Recruitment Status, Adverse Events, Outcome Measures, Participant Flow, Study Status, Baseline Characteristics, Document Section and Contacts/Locations
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Study NCT03982199
Submitted Date:  June 10, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: CR108634
Brief Title: A Study of an Ad26.RSV.preF-based Regimen in the Prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV)-Mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older
Official Title: A Randomized, Double-blind, Placebo-controlled Phase 2b Study to Assess the Efficacy, Immunogenicity and Safety of an Ad26.RSV.preF-based Regimen in the Prevention of RT PCR-confirmed RSV-mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older
Secondary IDs: VAC18193RSV2001 [Janssen Vaccines & Prevention B.V.]
Open or close this module Study Status
Record Verification: June 2019
Overall Status: Not yet recruiting
Study Start: August 12, 2019
Primary Completion: June 10, 2021 [Anticipated]
Study Completion: October 26, 2021 [Anticipated]
First Submitted: June 10, 2019
First Submitted that
Met QC Criteria:
June 10, 2019
First Posted: June 11, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
June 10, 2019
Last Update Posted: June 11, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Janssen Vaccines & Prevention B.V.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this study is to demonstrate the efficacy of active study vaccine in the prevention of reverse transcriptase polymerase chain reaction (RT-PCR) confirmed respiratory syncytial virus (RSV)-mediated lower respiratory tract disease (LRTD), when compared to placebo.
Detailed Description:
Open or close this module Conditions
Conditions: Respiratory Syncytial Viruses
Respiratory Tract Diseases
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 5800 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Group 1: RSV Vaccine
Participants will receive a single intramuscular (IM) injection of an adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV) vaccine at a single dose level on Day 1 and Day 365.
Biological: RSV Vaccine
Participants will receive a single IM injection of an Ad26-based RSV vaccine at a single dose level on Day 1 and Day 365.
Placebo Comparator: Group 2: Placebo
Participants will receive a single IM injection of placebo control on Day 1 and Day 365.
Biological: Placebo
Participants will receive a single IM injection of placebo control on Day 1 and Day 365.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Percentage of Participants with Protocol Defined Respiratory Syncytial Virus (RSV)-mediated Lower Respiratory Tract Disease (LRTD) Confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
[ Time Frame: Up to 1.6 years ]

Percentage of participants with protocol defined RSV-mediated LRTD confirmed by RT-PCR will be reported.
Secondary Outcome Measures:
1. Percentage of Participants with any RT-PCR-confirmed RSV Disease
[ Time Frame: Up to 1.6 years ]

Percentage of participants with any RT-PCR-confirmed RSV disease will be reported. RT-PCR-confirmed RSV disease is defined as new onset or worsening of any of the clinical symptoms (lower respiratory tract infection [LRTI], upper respiratory tract infection [URTI]) in combination with RSV confirmation by RT-PCR.
2. Percentage of Participants with Protocol Defined RSV-mediated LRTD Confirmed by Serology
[ Time Frame: Up to 1.6 years ]

Percentage of participants with protocol defined RSV-mediated LRTD confirmed by serology will be reported.
3. Percentage of Participants with Any Serology-confirmed RSV Disease
[ Time Frame: Up to 1.6 years ]

Percentage of participants with any serology-confirmed RSV disease will be reported. Serology-confirmed RSV disease is defined as new onset or worsening of any of the clinical symptoms (LRTI and URTI) in combination with serology confirmation of RSV.
4. RSV Neutralization Assay
[ Time Frame: Day 1 and Day 15 after each vaccination (up to 1.6 years) ]

Analysis of neutralizing antibodies to RSV A strain will be performed.
5. RSV Fusion Protein (F Protein) Binding Antibodies
[ Time Frame: Day 1 and Day 15 after each vaccination (up to 1.6 years) ]

Analysis of antibodies binding to RSV F protein in pre-fusion (pre-F) and/or post-fusion (post-F) form will be performed by enzyme-linked immunosorbent assay (ELISA).
6. RSV Glycoprotein (G Protein) Binding Antibodies
[ Time Frame: Day 3 to Day 5 and Day 29 of acute respiratory infection (ARI) episode ]

Analysis of antibodies binding to RSV G protein will be performed by ELISA.
7. Interferon Gamma (IFN-gamma) Enzyme-Linked Immunospot (ELISpot) Assay
[ Time Frame: Day 1 and Day 15 after each vaccination (up to 1.6 years) ]

IFN-gamma ELISpot assay will be performed to assess T-cell IFN-gamma responses to RSV F protein peptides.
8. Percentage of Participants With Solicited Local Adverse Events (AEs)
[ Time Frame: 7 days after each vaccination (Up to Day 372) ]

Solicited local AEs includes erythema, swelling, and pain/tenderness.
9. Percentage of Participants With Solicited Systemic AEs
[ Time Frame: 7 days after each vaccination (Up to Day 372) ]

Solicited systemic AEs includes fatigue, headache, nausea, myalgia, and fever (defined as an endogenous elevation of body temperature greater than or equal to [>=]38.0 degree Celsius, as recorded in at least one measurement).
10. Percentage of Participants With Unsolicited AEs
[ Time Frame: 28 days after each vaccination (Up to Day 393) ]

Unsolicited AEs are all AEs for which the participant is specifically not questioned in the participant eDiary.
11. Percentage of Participants With Serious Adverse Events (SAEs)
[ Time Frame: 6 months after each vaccination or until the end of the corresponding RSV season, whichever occurs later (up to 1.6 years) ]

An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Open or close this module Eligibility
Minimum Age: 65 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Participant must have a body mass index (BMI) less than (<)40 kilogram per meter square (kg/m^2)
  • Before randomization, a woman 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
  • Participant must be either in good or stable health. Participants may have mild to moderate underlying illnesses such as chronic cardiac diseases and chronic lung disease (asthma and chronic obstructive pulmonary disease [COPD]), congestive heart failure (CHF), hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are stable and medically controlled in the judgment of the investigator. Participants will be included on the basis of physical examination, medical history, and vital signs performed between informed consent form (ICF) signature and vaccination on Day 1
  • From the time of vaccination through 3 months after vaccination, participant agrees not to donate blood
  • Participant must be able to read, understand, and complete questionnaires in the eDiary
  • Participant must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study

Exclusion Criteria:

  • Participant has an acute illness (including acute respiratory illnesses) or body temperature greater than or equal to (>=)38.0 degree Celsius (ºC) within 24 hours prior to administration of study vaccine. In such a situation, enrollment at a later date is permitted
  • Participant has a severe or potentially life-threatening chronic disorder such as severe chronic cardiac diseases and severe chronic lung disease (asthma and COPD), advanced CHF, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any 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, limit, or confound the protocol-specified assessments
  • Participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
  • Per medical history, participant has chronic active hepatitis B or hepatitis C infection
  • Per medical history, participant has human immunodeficiency virus (HIV) type 1 or type 2 infection
  • Participant has a known allergy, or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine)
Open or close this module Contacts/Locations
Central Contact Person: Study Contact
Telephone: 844-434-4210
Email: JNJ.CT@sylogent.com
Study Officials: Janssen Vaccines & Prevention B.V. Clinical Trial
Study Director
Janssen Vaccines & Prevention B.V.
Locations: United States, Alabama
Optimal Research
Huntsville, Alabama, United States, 35807
United States, Arizona
Synexus Clinical Research US, Inc
Chandler, Arizona, United States, 85224
Synexus Clinical Research US, Inc
Phoenix, Arizona, United States, 85018
Central Phoenix Medical Clinic
Phoenix, Arizona, United States, 85020
United States, California
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801
Paradigm Clinical Research Centers, Inc.
Redding, California, United States, 96001
Benchmark Research
Sacramento, California, United States, 95684
Optimal Research
San Diego, California, United States, 92108
United States, Colorado
Synexus Clinical Research US, Inc
Aurora, Colorado, United States, 80014
Lynn Institute
Colorado Springs, Colorado, United States, 80920
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Optimal Research
Melbourne, Florida, United States, 32935
United States, Idaho
Advanced Clinical Research
Meridian, Idaho, United States, 83642
United States, Illinois
Optimal Research
Peoria, Illinois, United States, 61614
United States, Indiana
Synexus Clinical Research US, Inc
Evansville, Indiana, United States, 47714
United States, Iowa
The Iowa Clinic
West Des Moines, Iowa, United States, 50266
United States, Kansas
Hutchinson Clinic
Hutchinson, Kansas, United States, 67502
Johnson County Clin-Trials
Lenexa, Kansas, United States, 66219
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67205
United States, Maryland
Optimal Research
Rockville, Maryland, United States, 20850
United States, Minnesota
Synexus Clinical Research US, Inc
Richfield, Minnesota, United States, 55432
United States, Missouri
The Center For Pharmaceutical Research
Kansas City, Missouri, United States, 64114
Sundance Clinical Research
Saint Louis, Missouri, United States, 63141
Synexus Clinical Research US, Inc
Saint Louis, Missouri, United States, 63141
United States, Nebraska
Synexus Clinical Research US, Inc
Elkhorn, Nebraska, United States, 68022
Synexus Clinical Research US, Inc
Omaha, Nebraska, United States, 68144
United States, New York
United Medical Associates
Binghamton, New York, United States, 13903
Regional Clinical Research, Inc.
Endwell, New York, United States, 13760
University of Rochester / Rochester General Hospital
Rochester, New York, United States, 14621
United States, Ohio
Synexus Clinical Research US, Inc
Akron, Ohio, United States, 44311
Synexus Clinical Research US, Inc
Cincinnati, Ohio, United States, 45236
Rapid Medical Research
Cleveland, Ohio, United States, 44122
United States, Oklahoma
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Coastal Carolina Research Center
Mount Pleasant, South Carolina, United States, 29464
United States, Texas
Optimal Research
Austin, Texas, United States, 78705
Ventavia Research Group, LLC
Fort Worth, Texas, United States, 76104
United States, Utah
Synexus Clinical Research US, Inc
Murray, Utah, United States, 84123
Advanced Clinical Research
Salt Lake City, Utah, United States, 84123
Advanced Clinical Research
West Jordan, Utah, United States, 84088
Australia
Genesis Research Services
Broadmeadow, Australia, 2292
Monash Medical Centre
Clayton, Australia, 3168
Emeritus Research
Malvern East, Australia, VIC 3145
Australian Clinical Research Network
Maroubra, Australia, 2035
Mater Hospital Brisbane
South Brisbane, Australia, 4101
Chile
Hospital San Martin de Quillota
Quillota, Chile, 2260494
Bioclinica Santiago Bulnes
Santiago, Chile, 8331143
Facultad de Medicina Universidad de Chile
Santiago, Chile, 8380453
Centro de Estudios Clínicos Barros Luco
Santiago, Chile
Schönffeldt y Guerrero Limitada
Santiago de Chile, Chile, 8320000
New Zealand
Southern Clinical Trials Ltd
Auckland, New Zealand, 0626
Optimal Clinical Trials
Auckland, New Zealand, 1144
Southern Clinical Trials Ltd
Christchurch, New Zealand, 8024
P3 Research Ltd
Havelock North, New Zealand, 3410
P3 Research Ltd
Newtown, New Zealand, 6021
Lakeland Family Medical Services Ltd
Rotorua, New Zealand, 3010
P3 Research Ltd
Tauranga, New Zealand, 3110
Open or close this module IPDSharing
Plan to Share IPD: Yes

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

Supporting Information:
Time Frame:
Access Criteria:
URL: https://www.janssen.com/clinical-trials/transparency
Open or close this module References
Citations:
Links:
Available IPD/Information:

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