Clinical trial NCT05101486: A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years
Official title: A Randomized, Double-blind Phase 3 Study to Assess the Immunogenicity and Safety of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Syncytial Virus Prevention
Lead sponsor: Janssen Vaccines & Prevention B.V.
Sponsor class: INDUSTRY
First posted: 2021-11-01
Enrollment: 755
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses of Ad26.RSV.preF-based study vaccine lots representative of different aged vaccine in comparison to a non-aged Ad26.RSV.preF-based study vaccine lot.


Eligibility criteria: Inclusion Criteria:

* Before randomization, a participant must be: a) postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and b) not intending to conceive by any methods
* From the time of vaccination through 3 months after vaccination, agrees not to donate blood
* In the investigator's clinical judgment, a participant must be in stable health at the time of vaccination. Participants may have underlying illnesses such as hypertension, congestive heart failure, chronic obstructive pulmonary disease, Type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are stable at the time of vaccination, and these conditions receive routine follow-up by the participant's healthcare provider. Participants will be included on the basis of medical history and vital signs performed between informed consent form (ICF) signature and vaccination
* Must be able to read, understand, and complete questionnaires in the electronic diary (eDiary)
* Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
* Must be able to work with smartphones/tablets/computers

Exclusion Criteria:

* Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
* Abnormal function of the immune system resulting from clinical conditions or medication
* Per medical history, participant has chronic active hepatitis B or hepatitis C infection
* History of acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy
* Has had major surgery (per the investigator's judgment) within 4 weeks before administration of the study vaccine or will not have recovered from surgery per the investigator's judgment at time of vaccination
* Has had major psychiatric illness and/or drug or alcohol abuse which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures

Primary outcomes:
measure: Geometric Mean Titers (GMTs) of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) 14 Days Post Vaccination
timeFrame: 14 days post vaccination on Day 1 (Day 15)
Secondary outcomes:
measure: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days Post Vaccination
timeFrame: 14 days post vaccination on Day 1 (Day 15)
measure: Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days Post Vaccination
timeFrame: Up to Day 7 post vaccination on Day 1 (up to Day 8)
measure: Number of Participants With Solicited Systemic AEs for 7 Days Post Vaccination
timeFrame: Up to Day 7 post vaccination on Day 1 (up to Day 8)
measure: Number of Participants With Unsolicited AEs for 28 Days Post Vaccination
timeFrame: Up to 28 days post vaccination on Day 1 (up to Day 29)
measure: Number of Participants With Serious Adverse Events (SAEs) Until 6 Months Post Vaccination
timeFrame: From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183)
measure: Number of Participants With Adverse Event of Special Interests (AESIs) Until 6 Months Post Vaccination
timeFrame: From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183)
Other outcomes:
Locations:
city: Athens
country: United States
facility: North Alabama Research Center, LLC
state: Alabama
city: Vestavia Hills
country: United States
facility: Achieve Clinical Research, LLC
state: Alabama
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Milford
country: United States
facility: Clinical Research Consulting
state: Connecticut
city: DeLand
country: United States
facility: Accel Research Sites
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic Inc
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group
state: Florida
city: Miami
country: United States
facility: Suncoast Research Associates, LLC
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Elkridge
country: United States
facility: Centennial Medical Group
state: Maryland
city: Lincoln
country: United States
facility: Be Well Clinical Studies
state: Nebraska
city: Charlotte
country: United States
facility: American Health Network, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: CTI Clinical Trial and Consulting Services
state: Ohio
Study officials:
affiliation: Janssen Vaccines & Prevention B.V.
name: Janssen Vaccines & Prevention B.V. Clinical Trial
role: STUDY_DIRECTOR
References: