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

Respiratory Tract Diseases Clinical Trial

— CYPRESS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03982199
• Other study ID #: CR108634
• Secondary ID: VAC18193RSV2001
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2019
• Est. completion date: May 26, 2023

Study information

• Verified date: July 2023
• Source: Janssen Vaccines & Prevention B.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5815
• Est. completion date: May 26, 2023
• Est. primary completion date: June 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Respiratory Syncytial Viruses
• Respiratory Tract Diseases

Intervention

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, or 3 years.
• Placebo
Participants will receive a single IM injection of placebo control on Day 1.

Locations

Country	Name	City	State
United States	Synexus Clinical Research US, Inc	Akron	Ohio
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	Synexus Clinical Research US, Inc	Aurora	Colorado
United States	Optimal Research	Austin	Texas
United States	United Medical Associates	Binghamton	New York
United States	Advanced Clinical Research	Boise	Idaho
United States	Synexus Clinical Research US, Inc	Chandler	Arizona
United States	Synexus Clinical Research US, Inc	Cincinnati	Ohio
United States	Rapid Medical Research	Cleveland	Ohio
United States	Lynn Institute	Colorado Springs	Colorado
United States	Synexus Clinical Research US, Inc	Elkhorn	Nebraska
United States	Regional Clinical Research, Inc.	Endwell	New York
United States	Synexus Clinical Research US, Inc	Evansville	Indiana
United States	Ventavia Research Group, LLC	Fort Worth	Texas
United States	Optimal Research	Huntsville	Alabama
United States	Hutchinson Clinic	Hutchinson	Kansas
United States	The Center For Pharmaceutical Research	Kansas City	Missouri
United States	Johnson County Clin-Trials	Lenexa	Kansas
United States	Optimal Research	Melbourne	Florida
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Synexus Clinical Research US, Inc	Murray	Utah
United States	Heartland Research Associates, LLC	Newton	Kansas
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Synexus Clinical Research US, Inc	Omaha	Nebraska
United States	Optimal Research	Peoria	Illinois
United States	Central Phoenix Medical Clinic	Phoenix	Arizona
United States	Synexus Clinical Research US, Inc	Phoenix	Arizona
United States	Paradigm Clinical Research Centers, Inc.	Redding	California
United States	Synexus Clinical Research US, Inc	Richfield	Minnesota
United States	University of Rochester / Rochester General Hospital	Rochester	New York
United States	Optimal Research	Rockville	Maryland
United States	Benchmark Research	Sacramento	California
United States	Sundance Clinical Research	Saint Louis	Missouri
United States	Synexus Clinical Research US, Inc	Saint Louis	Missouri
United States	Advanced Clinical Research	Salt Lake City	Utah
United States	Optimal Research	San Diego	California
United States	Omega Medical Research	Warwick	Rhode Island
United States	The Iowa Clinic	West Des Moines	Iowa
United States	Advanced Clinical Research	West Jordan	Utah
United States	Heartland Research Associates, LLC	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Vaccines & Prevention B.V.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 up to 2 years 9 months
Secondary	Number of Participants With Any RT-PCR-confirmed RSV Disease		From screening up to end of the study (up to 3 years 9 months)
Secondary	RSV A2 Strain Neutralization Antibody Titers		From screening up to end of the study (up to 3 years 9 months)
Secondary	Pre-Fusion Immunoglobulin G (IgG) Serum Antibody Response as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)		From screening up to end of the study (up to 3 years 9 months)
Secondary	Post-Fusion IgG Serum Antibody Response as Assessed by ELISA		From screening up to end of the study (up to 3 years 9 months)
Secondary	Interferon-gamma (IFN-gamma) T-Cells Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot)		From screening up to end of the study (up to 3 years 9 months)
Secondary	Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After First Vaccination	An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness. Per protocol, all solicited local AEs were considered as related to intervention.	Up to Day 8 (7 days after first vaccination on Day 1)
Secondary	Number of Participants With Solicited Systemic AEs up to 7 Days After First Vaccination	An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs included fatigue, headache, myalgia, arthralgia, and fever (defined as an endogenous elevation of body temperature >=38.0°C, as recorded in at least one measurement).	Up to Day 8 (7 days after first vaccination on Day 1)
Secondary	Number of Participants With Unsolicited AEs up to 28 Days After First Vaccination	An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary.	Up to Day 29 (28 days after first vaccination on Day 1)
Secondary	Number of Participants With Solicited Local AEs 7 Days After Re-vaccination at 1, 2 and 3 Years		7 days after re-vaccination at 1, 2 and 3 years
Secondary	Number of Participants With Solicited Systemic AEs 7 Days After Re-vaccination at 1, 2 and 3 Years		7 days after re-vaccination at 1, 2 and 3 years
Secondary	Number of Participants With Unsolicited AEs 28 Days After Re-vaccination at 1, 2 and 3 Years		28 days after re-vaccination at 1, 2 and 3 years
Secondary	Number of Participants With Serious Adverse Events (SAEs) During the RSV Season		From screening up to end of the study (up to 3 years 9 months)
Secondary	Number of Participants With Adverse Events of Special Interests (AESI) During the RSV Season		From screening up to end of the study (up to 3 years 9 months)
Secondary	Number of Participants With SAE During ARI Follow-up Period		Up to 2 years 9 months