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RSV Vaccine for Respiratory Syncytial Virus (CYPRESS Trial)

Phase 2
Waitlist Available
Research Sponsored by Janssen Vaccines & Prevention B.V.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening up to end of the study (up to 3 years 9 months)
Awards & highlights

CYPRESS Trial Summary

This trial is testing a vaccine for RSV, a virus that causes respiratory problems. They want to see if the vaccine prevents people from getting the disease.

Eligible Conditions
  • Respiratory Syncytial Virus
  • Respiratory Diseases

CYPRESS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening up to end of the study (up to 3 years 9 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening up to end of the study (up to 3 years 9 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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)
Secondary outcome measures
Interferon-gamma (IFN-gamma) T-Cells Responses Analyzed by Enzyme-linked Immunospot Assay (ELISpot)
Number of Participants With Adverse Events of Special Interests (AESI) During the RSV Season
Number of Participants With Any RT-PCR-confirmed RSV Disease
+11 more

Side effects data

From 2019 Phase 2 trial • 713 Patients • NCT04071158
53%
Myalgia
8%
Pyrexia
7%
Injection site swelling
6%
Injection site erythema
2%
Vomiting
1%
Ear infection
1%
Fatigue
1%
Migraine
1%
Haemorrhoids
1%
Injection site pain
1%
Swelling
1%
Pharyngitis streptococcal
1%
Muscle strain
1%
Pharyngeal mass
1%
Axillary pain
1%
Tonsillitis
1%
Depression
1%
Cholecystitis acute
1%
Upper respiratory tract infection
1%
Headache
1%
Toothache
1%
Seasonal allergy
1%
Sinusitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap
RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo
RSV Vaccine 120 mcg With Tdap
RSV Vaccine 120 mcg With Placebo
Placebo/Tdap

CYPRESS Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1: RSV VaccineExperimental Treatment1 Intervention
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 II: Group 2: PlaceboPlacebo Group2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RSV Vaccine
2020
Completed Phase 2
~7030

Find a Location

Who is running the clinical trial?

Janssen Vaccines & Prevention B.V.Lead Sponsor
55 Previous Clinical Trials
1,128,533 Total Patients Enrolled
Janssen Vaccines & Prevention B.V. Clinical TrialStudy DirectorJanssen Vaccines & Prevention B.V.
47 Previous Clinical Trials
129,741 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent has this medical experiment been implemented in various healthcare facilities?

"At the present, this clinical trial is welcoming enrollees from a total of 40 medical sites. These include Boise, Kansas City and Binghamton in addition to other cities around the country. To curtail any potential travel demands associated with participation, it may be beneficial to select an affiliated clinic located near you."

Answered by AI

Is there still an opportunity to join this investigation?

"According to the medical database hosted on clinicaltrials.gov, this trial is not currently enrolling. Initially posted in August 2019 and last edited November 2020, no new patients are being sought at this time; however there are 92 other trials with active recruitment requirements available now."

Answered by AI

Are there any known adverse effects associated with the RSV Vaccine?

"According to our team at Power, the RSV Vaccine scored a 2 on a scale of 1-3. This is owed to its progression through Phase 2 trials thus far and confirmation that it has been deemed safe but not yet effective."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Arizona
Louisiana
Other
How old are they?
18 - 65
What site did they apply to?
Central Phoenix Medical Clinic
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
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
2019. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03982199.
~1026 spots leftby Apr 2025
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