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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03982199
Registration number
NCT03982199
Ethics application status
Date submitted
10/06/2019
Date registered
11/06/2019
Date last updated
24/07/2023
Titles & IDs
Public title
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
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Scientific 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
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Secondary ID [1]
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VAC18193RSV2001
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Secondary ID [2]
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CR108634
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Universal Trial Number (UTN)
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Trial acronym
CYPRESS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Viruses
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Respiratory Tract Diseases
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - RSV Vaccine
Other interventions - Placebo
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, and 1C to receive revaccination with Ad26.RSV.preF based vaccine at 1 year, 2 years, and 3 years respectively after the first vaccination.
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, 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.
Other 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.
Other interventions: Placebo
Participants will receive a single IM injection of placebo control on Day 1.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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)
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Assessment method [1]
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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.
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Timepoint [1]
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From screening up to 2 years 9 months
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Secondary outcome [1]
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Number of Participants With Any RT-PCR-confirmed RSV Disease
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Assessment method [1]
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Timepoint [1]
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From screening up to end of the study (up to 3 years 9 months)
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Secondary outcome [2]
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RSV A2 Strain Neutralization Antibody Titers
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Assessment method [2]
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Timepoint [2]
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From screening up to end of the study (up to 3 years 9 months)
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Secondary outcome [3]
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Pre-Fusion Immunoglobulin G (IgG) Serum Antibody Response as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
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Assessment method [3]
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Timepoint [3]
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From screening up to end of the study (up to 3 years 9 months)
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Secondary outcome [4]
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Post-Fusion IgG Serum Antibody Response as Assessed by ELISA
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Assessment method [4]
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Timepoint [4]
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From screening up to end of the study (up to 3 years 9 months)
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Secondary outcome [5]
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Interferon-gamma (IFN-gamma) T-Cells Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot)
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Assessment method [5]
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Timepoint [5]
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From screening up to end of the study (up to 3 years 9 months)
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Secondary outcome [6]
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Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After First Vaccination
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Assessment method [6]
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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.
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Timepoint [6]
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Up to Day 8 (7 days after first vaccination on Day 1)
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Secondary outcome [7]
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Number of Participants With Solicited Systemic AEs up to 7 Days After First Vaccination
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Assessment method [7]
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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).
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Timepoint [7]
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Up to Day 8 (7 days after first vaccination on Day 1)
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Secondary outcome [8]
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Number of Participants With Unsolicited AEs up to 28 Days After First Vaccination
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Assessment method [8]
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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.
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Timepoint [8]
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Up to Day 29 (28 days after first vaccination on Day 1)
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Secondary outcome [9]
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Number of Participants With Solicited Local AEs 7 Days After Re-vaccination at 1, 2 and 3 Years
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Assessment method [9]
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Timepoint [9]
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7 days after re-vaccination at 1, 2 and 3 years
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Secondary outcome [10]
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Number of Participants With Solicited Systemic AEs 7 Days After Re-vaccination at 1, 2 and 3 Years
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Assessment method [10]
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Timepoint [10]
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7 days after re-vaccination at 1, 2 and 3 years
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Secondary outcome [11]
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Number of Participants With Unsolicited AEs 28 Days After Re-vaccination at 1, 2 and 3 Years
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Assessment method [11]
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Timepoint [11]
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28 days after re-vaccination at 1, 2 and 3 years
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Secondary outcome [12]
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Number of Participants With Serious Adverse Events (SAEs) During the RSV Season
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Assessment method [12]
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Timepoint [12]
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From screening up to end of the study (up to 3 years 9 months)
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Secondary outcome [13]
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Number of Participants With Adverse Events of Special Interests (AESI) During the RSV Season
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Assessment method [13]
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Timepoint [13]
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From screening up to end of the study (up to 3 years 9 months)
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Secondary outcome [14]
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Number of Participants With SAE During ARI Follow-up Period
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Assessment method [14]
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Timepoint [14]
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Up to 2 years 9 months
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Eligibility
Key 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
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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)
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/05/2023
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Sample size
Target
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Accrual to date
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Final
5815
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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State/province [2]
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Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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State/province [6]
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Idaho
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United States of America
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State/province [7]
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Illinois
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United States of America
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Indiana
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United States of America
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Iowa
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Country [10]
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United States of America
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State/province [10]
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Kansas
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Country [11]
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United States of America
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State/province [11]
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Maryland
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Country [12]
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United States of America
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Minnesota
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Country [13]
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State/province [13]
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Missouri
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Country [14]
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State/province [14]
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Nebraska
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New York
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Ohio
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Oklahoma
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Rhode Island
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United States of America
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State/province [19]
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South Carolina
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Texas
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United States of America
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Utah
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Vaccines & Prevention B.V.
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03982199
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Janssen Vaccines & Prevention B.V. Clinical Trial
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Address
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Janssen Vaccines & Prevention B.V.
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03982199
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