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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

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ClinicalTrials.gov Identifier: NCT03982199
Recruitment Status : Not yet recruiting
First Posted : June 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

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.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Viruses Respiratory Tract Diseases Biological: RSV Vaccine Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Estimated Study Start Date : August 12, 2019
Estimated Primary Completion Date : June 10, 2021
Estimated Study Completion Date : October 26, 2021

Arm Intervention/treatment
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.




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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982199


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

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Locations
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United States, Alabama
Optimal Research Not yet recruiting
Huntsville, Alabama, United States, 35807
United States, Arizona
Synexus Clinical Research US, Inc Not yet recruiting
Chandler, Arizona, United States, 85224
Synexus Clinical Research US, Inc Not yet recruiting
Phoenix, Arizona, United States, 85018
Central Phoenix Medical Clinic Not yet recruiting
Phoenix, Arizona, United States, 85020
United States, California
Anaheim Clinical Trials, LLC Not yet recruiting
Anaheim, California, United States, 92801
Paradigm Clinical Research Centers, Inc. Not yet recruiting
Redding, California, United States, 96001
Benchmark Research Not yet recruiting
Sacramento, California, United States, 95684
Optimal Research Not yet recruiting
San Diego, California, United States, 92108
United States, Colorado
Synexus Clinical Research US, Inc Not yet recruiting
Aurora, Colorado, United States, 80014
Lynn Institute Not yet recruiting
Colorado Springs, Colorado, United States, 80920
United States, Florida
University of Florida Not yet recruiting
Gainesville, Florida, United States, 32610
Optimal Research Not yet recruiting
Melbourne, Florida, United States, 32935
United States, Idaho
Advanced Clinical Research Not yet recruiting
Meridian, Idaho, United States, 83642
United States, Illinois
Optimal Research Not yet recruiting
Peoria, Illinois, United States, 61614
United States, Indiana
Synexus Clinical Research US, Inc Not yet recruiting
Evansville, Indiana, United States, 47714
United States, Iowa
The Iowa Clinic Not yet recruiting
West Des Moines, Iowa, United States, 50266
United States, Kansas
Hutchinson Clinic Not yet recruiting
Hutchinson, Kansas, United States, 67502
Johnson County Clin-Trials Not yet recruiting
Lenexa, Kansas, United States, 66219
Heartland Research Associates, LLC Not yet recruiting
Wichita, Kansas, United States, 67205
United States, Maryland
Optimal Research Not yet recruiting
Rockville, Maryland, United States, 20850
United States, Minnesota
Synexus Clinical Research US, Inc Not yet recruiting
Richfield, Minnesota, United States, 55432
United States, Missouri
The Center For Pharmaceutical Research Not yet recruiting
Kansas City, Missouri, United States, 64114
Sundance Clinical Research Not yet recruiting
Saint Louis, Missouri, United States, 63141
Synexus Clinical Research US, Inc Not yet recruiting
Saint Louis, Missouri, United States, 63141
United States, Nebraska
Synexus Clinical Research US, Inc Not yet recruiting
Elkhorn, Nebraska, United States, 68022
Synexus Clinical Research US, Inc Not yet recruiting
Omaha, Nebraska, United States, 68144
United States, New York
United Medical Associates Not yet recruiting
Binghamton, New York, United States, 13903
Regional Clinical Research, Inc. Not yet recruiting
Endwell, New York, United States, 13760
University of Rochester / Rochester General Hospital Not yet recruiting
Rochester, New York, United States, 14621
United States, Ohio
Synexus Clinical Research US, Inc Not yet recruiting
Akron, Ohio, United States, 44311
Synexus Clinical Research US, Inc Not yet recruiting
Cincinnati, Ohio, United States, 45236
Rapid Medical Research Not yet recruiting
Cleveland, Ohio, United States, 44122
United States, Oklahoma
Lynn Health Science Institute Not yet recruiting
Oklahoma City, Oklahoma, United States, 73112
United States, Rhode Island
Omega Medical Research Not yet recruiting
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Coastal Carolina Research Center Not yet recruiting
Mount Pleasant, South Carolina, United States, 29464
United States, Texas
Optimal Research Not yet recruiting
Austin, Texas, United States, 78705
Ventavia Research Group, LLC Not yet recruiting
Fort Worth, Texas, United States, 76104
United States, Utah
Synexus Clinical Research US, Inc Not yet recruiting
Murray, Utah, United States, 84123
Advanced Clinical Research Not yet recruiting
Salt Lake City, Utah, United States, 84123
Advanced Clinical Research Not yet recruiting
West Jordan, Utah, United States, 84088
Australia
Paratus Clinical Blacktown Clinic Not yet recruiting
Blacktown, Australia, 2148
Genesis Research Services Not yet recruiting
Broadmeadow, Australia, 2292
Monash Medical Centre Not yet recruiting
Clayton, Australia, 3168
Northside Health Not yet recruiting
Coffs Harbour, Australia, 2450
Paratus Clinical Kanwal Clinic Not yet recruiting
Kanwal, Australia, 2059
Emeritus Research Not yet recruiting
Malvern East, Australia, VIC 3145
Australian Clinical Research Network Not yet recruiting
Maroubra, Australia, 2035
Mater Hospital Brisbane Not yet recruiting
South Brisbane, Australia, 4101
Chile
Hospital San Martin de Quillota Not yet recruiting
Quillota, Chile, 2260494
Schönffeldt y Guerrero Limitada Not yet recruiting
Santiago de Chile, Chile, 8320000
Centro de Investigaciones Medicas Respiratorias Not yet recruiting
Santiago, Chile, 7500692
Bioclinica Santiago Bulnes Not yet recruiting
Santiago, Chile, 8331143
Facultad de Medicina Universidad de Chile Not yet recruiting
Santiago, Chile, 8380453
Centro de Estudios Clínicos Barros Luco Withdrawn
Santiago, Chile
New Zealand
Southern Clinical Trials Ltd Not yet recruiting
Auckland, New Zealand, 0626
Optimal Clinical Trials Not yet recruiting
Auckland, New Zealand, 1144
Southern Clinical Trials Ltd Not yet recruiting
Christchurch, New Zealand, 8024
P3 Research Ltd Not yet recruiting
Havelock North, New Zealand, 3410
P3 Research Ltd Not yet recruiting
Newtown, New Zealand, 6021
Lakeland Family Medical Services Ltd Not yet recruiting
Rotorua, New Zealand, 3010
P3 Research Ltd Not yet recruiting
Tauranga, New Zealand, 3110
Sponsors and Collaborators
Janssen Vaccines & Prevention B.V.
Investigators
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Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.

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Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT03982199     History of Changes
Other Study ID Numbers: CR108634
VAC18193RSV2001 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs