Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Respiratory Syncytial Viruses
Respiratory Tract Diseases
Lead sponsor: Janssen Vaccines & Prevention B.V.
Sponsor class: INDUSTRY
First posted: 2019-06-11
Enrollment: 5815
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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 (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)

Primary outcomes:
measure: Number of Participants With First Occurrence of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV) Mediated Lower Respiratory Tract Disease (LRTD)
timeFrame: From screening (Day 1) up to 9 months
Secondary outcomes:
measure: Main Cohorts: Number of Participants With Any RT-PCR-confirmed RSV Disease
timeFrame: From screening (Day 1) up to 9 months
measure: Main Cohorts: Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers
timeFrame: Days 15, 85, 169, 365
measure: Revaccination Subcohorts: Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers
timeFrame: Days 15, 365, 379, 393, 449, 730, 737, 744, 758
measure: Revaccination Subcohorts: Geometric Mean Titers (GMTs) of Prefusion F-protein (Pre-F) A Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
timeFrame: Day 15: Arms 3 to 7,13 and 14; Days 365, 379, 393, 449, 533: Arms 3 to 7; Day 730: Arms 4 to 7; Days 737, 744, 758: Arms 5 to 7; Day 1095, 1109: Arms 13 and 14
measure: Revaccination Subcohort 2A: T-cell Interferon (IFN) Gamma Responses to RSV F Protein Peptides Analyzed by Enzyme-linked Immunospot Assay (ELISpot)
timeFrame: Days 730, 744, 758
measure: Main Cohorts: T-cell Interferon (IFN) Gamma Responses to RSV F Protein Peptides Analyzed by Enzyme-linked Immunospot Assay (ELISpot)
timeFrame: Days 15, 85, 169, 365, 533
measure: Main Cohorts: Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After First Vaccination
timeFrame: Up to Day 8 (7 days after first vaccination on Day 1)
measure: Main Cohorts: Number of Participants With Solicited Systemic AEs up to 7 Days After First Vaccination
timeFrame: Up to Day 8 (7 days after first vaccination on Day 1)
measure: Main Cohorts: Number of Participants With Unsolicited AEs up to 28 Days After First Vaccination
timeFrame: Up to Day 29 (28 days after first vaccination on Day 1)
measure: Revaccination Subcohorts: Number of Participants With Solicited Local AEs 7 Days After Re-vaccination up to 1, 2 and 3 Years
timeFrame: Arms 3,4: 7 days after revacc at 1 year (up to Day 372); Arm 5,6,7,8,9: 7 days after revacc at 2 years (up to Day 737); Arms 10,11,12,13,14: 7 days after revacc at 3 year (up to Day 1102)
measure: Revaccination Subcohorts: Number of Participants With Solicited Systemic AEs 7 Days After Re-vaccination up to 1, 2 and 3 Years
timeFrame: Arms 3,4: 7 days after revacc at 1 year (up to Day 372); Arm 5,6,7,8,9: 7 days after revacc at 2 years (up to Day 737); Arms 10,11,12,13,14: 7 days after revacc at 3 year (up to Day 1102)
measure: Revaccination Subcohorts: Number of Participants With Unsolicited AEs 28 Days After Re-vaccination up to 1, 2 and 3 Years
timeFrame: Arms 3,4: 28 days after revacc at 1 year (up to Day 393); Arms 5,6,7,8,9: 28 days after revacc at 2 years (up to Day 758); Arms 10,11,12,13,14: 28 days after revaccination at 3 year (up to Day 1123)
measure: Revaccination Subcohorts: Number of Participants With Adverse Events of Special Interests (AESI)
timeFrame: Arms 3,4: 6 months after revacc at 1 year (up to Day 547); Arm 5,6,7,8,9: 6 months after revacc at 2 years (up to Day 912); Arms 10,11,12,13,14: 6 months after revacc at 3 year (up to Day 1277)
measure: Main Cohorts:Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to Day 1095
measure: Revaccination Subcohorts: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Arms 3,4: 6 months after revacc at 1 year (up to Day 547); Arm 5,6,7,8,9: 6 months after revacc at 2 years (up to Day 912); Arms 10,11,12,13,14: 6 months after revacc at 3 year (up to Day 1277)
measure: Main Cohorts: Geometric Mean Titers (GMTs) of Prefusion F-protein (Pre-F) A Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
timeFrame: Days 15, 85, 169, 365, 533
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Optimal Research
state: Alabama
city: Chandler
country: United States
facility: Synexus Clinical Research US Inc
state: Arizona
city: Phoenix
country: United States
facility: Synexus Clinical Research US Inc
state: Arizona
city: Phoenix
country: United States
facility: Central Phoenix Medical Clinic
state: Arizona
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Redding
country: United States
facility: Paradigm Clinical Research Centers, Inc.
state: California
city: Sacramento
country: United States
facility: Benchmark Research
state: California
city: San Diego
country: United States
facility: Optimal Research
state: California
city: Aurora
country: United States
facility: Synexus Clinical Research US Inc
state: Colorado
city: Colorado Springs
country: United States
facility: Lynn Institute
state: Colorado
city: Melbourne
country: United States
facility: Optimal Research
state: Florida
city: Boise
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Peoria
country: United States
facility: Optimal Research
state: Illinois
city: Evansville
country: United States
facility: Synexus Clinical Research US Inc
state: Indiana
city: West Des Moines
country: United States
facility: The Iowa Clinic
state: Iowa
city: Hutchinson
country: United States
facility: Hutchinson Clinic
state: Kansas
city: Lenexa
country: United States
facility: Johnson County Clin-Trials
state: Kansas
city: Newton
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Rockville
country: United States
facility: Optimal Research
state: Maryland
city: Richfield
country: United States
facility: Synexus Clinical Research US Inc
state: Minnesota
city: Kansas City
country: United States
facility: The Center For Pharmaceutical Research
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Saint Louis
country: United States
facility: Synexus Clinical Research US Inc
state: Missouri
city: Elkhorn
country: United States
facility: Synexus Clinical Research US Inc
state: Nebraska
city: Omaha
country: United States
facility: Synexus Clinical Research US Inc
state: Nebraska
city: Binghamton
country: United States
facility: United Medical Associates
state: New York
city: Endwell
country: United States
facility: Regional Clinical Research, Inc.
state: New York
city: Rochester
country: United States
facility: University of Rochester / Rochester General Hospital
state: New York
city: Akron
country: United States
facility: Synexus Clinical Research US Inc
state: Ohio
city: Cincinnati
country: United States
facility: Synexus Clinical Research US Inc
state: Ohio
city: Cleveland
country: United States
facility: Rapid Medical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Austin
country: United States
facility: Optimal Research
state: Texas
city: Fort Worth
country: United States
facility: Ventavia Research Group, LLC
state: Texas
city: Murray
country: United States
facility: Synexus Clinical Research US Inc
state: Utah
city: Salt Lake City
country: United States
facility: Advanced Clinical Research
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
Study officials:
affiliation: Janssen Vaccines & Prevention B.V.
name: Janssen Vaccines & Prevention B.V. Clinical Trial
role: STUDY_DIRECTOR
References: