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

NCT ID: NCT03982199

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5815 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2023-05-26

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.

Conditions

Respiratory Syncytial Viruses; Respiratory Tract Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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, and 1C to receive revaccination with Ad26.RSV.preF based vaccine at 1 year, 2 years, and 3 years respectively after the first vaccination.

Group Type: EXPERIMENTAL

RSV Vaccine

Intervention Type: BIOLOGICAL

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, or 3 years.

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, and 2C, and will first receive Ad26.RSV.preF based vaccine at years 1, 2, and 3. 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.

Group Type: PLACEBO_COMPARATOR

RSV Vaccine

Intervention Type: BIOLOGICAL

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, or 3 years.

Placebo

Intervention Type: BIOLOGICAL

Participants will receive a single IM injection of placebo control on Day 1.

Interventions

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, or 3 years.

Intervention Type: BIOLOGICAL

Placebo

Participants will receive a single IM injection of placebo control on Day 1.

Intervention Type: BIOLOGICAL

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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Vaccines & Prevention B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Vaccines & Prevention B.V. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Vaccines & Prevention B.V.

Locations

Optimal Research

Huntsville, Alabama, United States

Synexus Clinical Research US Inc

Chandler, Arizona, United States

Synexus Clinical Research US Inc

Phoenix, Arizona, United States

Central Phoenix Medical Clinic

Phoenix, Arizona, United States

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Paradigm Clinical Research Centers, Inc.

Redding, California, United States

Benchmark Research

Sacramento, California, United States

Optimal Research

San Diego, California, United States

Synexus Clinical Research US Inc

Aurora, Colorado, United States

Lynn Institute

Colorado Springs, Colorado, United States

Optimal Research

Melbourne, Florida, United States

Advanced Clinical Research

Boise, Idaho, United States

Optimal Research

Peoria, Illinois, United States

Synexus Clinical Research US Inc

Evansville, Indiana, United States

The Iowa Clinic

West Des Moines, Iowa, United States

Hutchinson Clinic

Hutchinson, Kansas, United States

Johnson County Clin-Trials

Lenexa, Kansas, United States

Heartland Research Associates, LLC

Newton, Kansas, United States

Heartland Research Associates, LLC

Wichita, Kansas, United States

Optimal Research

Rockville, Maryland, United States

Synexus Clinical Research US Inc

Richfield, Minnesota, United States

The Center For Pharmaceutical Research

Kansas City, Missouri, United States

Sundance Clinical Research

St Louis, Missouri, United States

Synexus Clinical Research US Inc

St Louis, Missouri, United States

Synexus Clinical Research US Inc

Elkhorn, Nebraska, United States

Synexus Clinical Research US Inc

Omaha, Nebraska, United States

United Medical Associates

Binghamton, New York, United States

Regional Clinical Research, Inc.

Endwell, New York, United States

University of Rochester / Rochester General Hospital

Rochester, New York, United States

Synexus Clinical Research US Inc

Akron, Ohio, United States

Synexus Clinical Research US Inc

Cincinnati, Ohio, United States

Rapid Medical Research

Cleveland, Ohio, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Omega Medical Research

Warwick, Rhode Island, United States

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, United States

Optimal Research

Austin, Texas, United States

Ventavia Research Group, LLC

Fort Worth, Texas, United States

Synexus Clinical Research US Inc

Murray, Utah, United States

Advanced Clinical Research

Salt Lake City, Utah, United States

Advanced Clinical Research

West Jordan, Utah, United States

Countries

United States

References

Falsey AR, Hosman T, Bastian AR, Vandenberghe S, Chan EKH, Douoguih M, Heijnen E, Comeaux CA, Callendret B; CYPRESS investigators. Long-term efficacy and immunogenicity of Ad26.RSV.preF-RSV preF protein vaccine (CYPRESS): a randomised, double-blind, placebo-controlled, phase 2b study. Lancet Infect Dis. 2024 Sep;24(9):1015-1024. doi: 10.1016/S1473-3099(24)00226-3. Epub 2024 May 24.

Reference Type: DERIVED

PMID: 38801826 (View on PubMed)

Falsey AR, Williams K, Gymnopoulou E, Bart S, Ervin J, Bastian AR, Menten J, De Paepe E, Vandenberghe S, Chan EKH, Sadoff J, Douoguih M, Callendret B, Comeaux CA, Heijnen E; CYPRESS Investigators. Efficacy and Safety of an Ad26.RSV.preF-RSV preF Protein Vaccine in Older Adults. N Engl J Med. 2023 Feb 16;388(7):609-620. doi: 10.1056/NEJMoa2207566.

Reference Type: DERIVED

PMID: 36791161 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

VAC18193RSV2001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108634

Identifier Type: -

Identifier Source: org_study_id