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

NCT03982199 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: CR108634VAC18193RSV2001
• Study Type: interventional
• Target: 5,815
• Locations: 1 country
• Sites: 40

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

Outcome Measures

Primary Outcomes (1)

• 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)

  Number of participants with first occurrence of RT-PCR-confirmed RSV mediated LRTD according to case definition-1, 2 and 3 were reported. Case definition 1 was defined as having a new onset or worsening in 3 or more symptoms of lower respiratory tract infection (LRTI) ; Case definition 2 was defined as having a new onset or worsening in greater than or equal to (\>=) 2 symptoms of LRTI; and Case definition 3 was defined as having a new onset or worsening in \>=2 OR \>=1 symptoms of LRTI with \>=1 systemic symptoms. Systemic symptoms (fatigue/malaise and fever/feverishness) and symptoms of LRTI (cough, shortness of breath, sputum production, wheezing and tachypnea) were collected via the RiiQ. RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The total LRTD symptom score was calculated as the mean of the LRTD symptom scores.

  From screening (Day 1) up to 9 months

Secondary Outcomes (16)

• Main Cohorts: Number of Participants With Any RT-PCR-confirmed RSV Disease

  From screening (Day 1) up to 9 months

• Main Cohorts: Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers

  Days 15, 85, 169, 365

• Revaccination Subcohorts: Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers

  Days 15, 365, 379, 393, 449, 730, 737, 744, 758

• Revaccination Subcohorts: Geometric Mean Titers (GMTs) of Prefusion F-protein (Pre-F) A Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)

  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

• Revaccination Subcohort 2A: T-cell Interferon (IFN) Gamma Responses to RSV F Protein Peptides Analyzed by Enzyme-linked Immunospot Assay (ELISpot)

  Days 730, 744, 758

Study Arms (2)

Group 1: RSV Vaccine

EXPERIMENTAL

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.

Biological: RSV Vaccine

Group 2: Placebo

PLACEBO COMPARATOR

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.

Biological: RSV Vaccine; Biological: Placebo

Interventions

RSV Vaccine 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 1: RSV Vaccine; Group 2: Placebo

Placebo BIOLOGICAL

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

Group 2: Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Vaccines & Prevention B.V.: lead

Study Sites (40)

Optimal Research

Huntsville, Alabama, 35802, United States

Location

Synexus Clinical Research US Inc

Chandler, Arizona, 85224, United States

Location

Synexus Clinical Research US Inc

Phoenix, Arizona, 85018, United States

Location

Central Phoenix Medical Clinic

Phoenix, Arizona, 85020, United States

Location

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Paradigm Clinical Research Centers, Inc.

Redding, California, 96001, United States

Location

Benchmark Research

Sacramento, California, 95684, United States

Location

Optimal Research

San Diego, California, 92108, United States

Location

Synexus Clinical Research US Inc

Aurora, Colorado, 80014, United States

Location

Lynn Institute

Colorado Springs, Colorado, 80920, United States

Location

Optimal Research

Melbourne, Florida, 32934, United States

Location

Advanced Clinical Research

Boise, Idaho, 83642, United States

Location

Optimal Research

Peoria, Illinois, 61614, United States

Location

Synexus Clinical Research US Inc

Evansville, Indiana, 47714, United States

Location

The Iowa Clinic

West Des Moines, Iowa, 50266, United States

Location

Hutchinson Clinic

Hutchinson, Kansas, 67502, United States

Location

Johnson County Clin-Trials

Lenexa, Kansas, 66219, United States

Location

Heartland Research Associates, LLC

Newton, Kansas, 67114, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67205, United States

Location

Optimal Research

Rockville, Maryland, 20850, United States

Location

Synexus Clinical Research US Inc

Richfield, Minnesota, 55432, United States

Location

The Center For Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

Sundance Clinical Research

St Louis, Missouri, 63141, United States

Location

Synexus Clinical Research US Inc

St Louis, Missouri, 63141, United States

Location

Synexus Clinical Research US Inc

Elkhorn, Nebraska, 68022, United States

Location

Synexus Clinical Research US Inc

Omaha, Nebraska, 68144, United States

Location

United Medical Associates

Binghamton, New York, 13901, United States

Location

Regional Clinical Research, Inc.

Endwell, New York, 13760, United States

Location

University of Rochester / Rochester General Hospital

Rochester, New York, 14621, United States

Location

Synexus Clinical Research US Inc

Akron, Ohio, 44311, United States

Location

Synexus Clinical Research US Inc

Cincinnati, Ohio, 45236, United States

Location

Rapid Medical Research

Cleveland, Ohio, 44122, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Optimal Research

Austin, Texas, 78705, United States

Location

Ventavia Research Group, LLC

Fort Worth, Texas, 76104, United States

Location

Synexus Clinical Research US Inc

Murray, Utah, 84123, United States

Location

Advanced Clinical Research

Salt Lake City, Utah, 84123, United States

Location

Advanced Clinical Research

West Jordan, Utah, 84088, United States

Location

Related Publications (2)

• 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.

  PMID: 38801826 DERIVED

• 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.

  PMID: 36791161 DERIVED

MeSH Terms

Conditions

Respiratory Tract Diseases

Interventions

Respiratory Syncytial Virus Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Medical Leader
• Organization: Janssen Vaccines & Prevention B.V.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Vaccines & Prevention B.V. Clinical Trial

  Janssen Vaccines & Prevention B.V.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 11, 2019
• Study Start: August 1, 2019
• Primary Completion: June 6, 2022
• Study Completion: May 26, 2023
• Last Updated: May 25, 2025
• Results First Posted: July 24, 2023

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (40)