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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 (CYPRESS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03982199
Recruitment Status : Active, not recruiting
First Posted : June 11, 2019
Last Update Posted : January 19, 2022
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Tracking Information
First Submitted Date  ICMJE June 10, 2019
First Posted Date  ICMJE June 11, 2019
Last Update Posted Date January 19, 2022
Actual Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date June 3, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2021)
  • Percentage of Participants with any RT-PCR-confirmed RSV Disease [ Time Frame: Up to 2.6 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.
  • RSV Neutralization Assay [ Time Frame: Day 1, Day 15 and Day 365 after vaccination (up to 1.6 years) ]
    Analysis of neutralizing antibodies to RSV A and/or B strain will be performed.
  • RSV Fusion Protein (F Protein) Binding Antibodies [ Time Frame: Day 1, Day 15 and Day 365 after 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).
  • Interferon Gamma (IFN-gamma) Enzyme-Linked Immunospot (ELISpot) Assay [ Time Frame: Day 1, Day 15 and Day 365 after 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.
  • Percentage of Participants With Solicited Local Adverse Events (AEs) [ Time Frame: 7 days after vaccination (Day 8) ]
    Solicited local AEs includes erythema, swelling, and pain/tenderness.
  • Percentage of Participants With Solicited Systemic AEs [ Time Frame: 7 days after vaccination (Day 8) ]
    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).
  • Percentage of Participants With Unsolicited AEs [ Time Frame: 28 days after vaccination (Day 29) ]
    Unsolicited AEs are all AEs for which the participant is specifically not questioned in the participant eDiary.
  • Percentage of Participants With Solicited Local Adverse Events (AEs) in Revaccination Subcohorts [ Time Frame: 7 Days after revaccination at 1 year, 2 years, 3 years and 4 Years (Up to 4.5 Years) ]
    Solicited local AEs includes erythema, swelling, and pain/tenderness.
  • Percentage of Participants With Solicited Systemic Adverse Events (AEs) in Revaccination Subcohorts [ Time Frame: 7 Days after revaccination at 1 year, 2 years, 3 years and 4 Years (Up to 4.5 Years) ]
    Solicited systemic AEs includes fatigue, headache, nausea, myalgia, and fever (defined as an endogenous elevation of body temperature >=38.0 degree Celsius, as recorded in at least one measurement).
  • Percentage of Participants With Unsolicited AEs in Revaccination Subcohorts [ Time Frame: 28 Days after revaccination at 1 year, 2 years, 3 years and 4 Years (Up to 4.5 Years) ]
    Unsolicited AEs are all AEs for which the participant is specifically not questioned in the participant eDiary.
  • Percentage of Participants With Serious Adverse Events (SAEs) During the RSV Season [ Time Frame: Up to 4.5 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.
  • Percentage of Participants with Adverse Events of Special Interest (AESIs) [ Time Frame: 6 months after revaccination (up to 4.5 years) ]
    Percentage of participants with AESIs will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI.
  • Percentage of Participants With SAEs During the Acute Respiratory Infection (ARI) Follow-up Periods [ Time Frame: Up to 4.5 years ]
    An 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Respiratory Syncytial Viruses
  • Respiratory Tract Diseases
Intervention  ICMJE
  • 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 revaccination after either 1 year, 2 years, 3 years or 4 years.
  • Biological: Placebo
    Participants will receive a single IM injection of placebo control on Day 1.
Study Arms  ICMJE
  • 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. Participants will then be divided into revaccination subcohorts: 1A, 1B, 1C and 1D to receive revaccination with Ad26.RSV.preF based vaccine at 1 year, 2 years, 3 years and 4 years respectively after the first vaccination.
    Intervention: Biological: RSV Vaccine
  • Placebo Comparator: Group 2: Placebo
    Participants will receive a single IM injection of placebo control on Day 1. Participants will then be divided into revaccination subcohorts 2A, 2B, 2C, 2D and will first receive Ad26.RSV.preF based vaccine at years 1, 2, 3 and 4. In subcohorts 2A and 2B, participants will receive a revaccination one year later with either Ad26.RSV.preF based vaccine, study vaccine A or study vaccine B.
    Interventions:
    • Biological: RSV Vaccine
    • Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 27, 2020)
5815
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2019)
5800
Estimated Study Completion Date  ICMJE May 16, 2024
Estimated Primary Completion Date June 3, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 (or a paper safety diary, if designated by the sponsor)
  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Australia,   Chile,   New Zealand
 
Administrative Information
NCT Number  ICMJE NCT03982199
Other Study ID Numbers  ICMJE CR108634
VAC18193RSV2001 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Janssen Vaccines & Prevention B.V.
Study Sponsor  ICMJE Janssen Vaccines & Prevention B.V.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.
PRS Account Janssen Vaccines & Prevention B.V.
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP