Clinical trial NCT05083585: A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Aged 60 - 75 Years Old
Official title: A Randomized, Double-blind Phase 3 Study to Compare the Immunogenicity of Clinical Trial Material of an Ad26.RSV.preF-based Vaccine for Phase 3 With Clinical Trial Material Representative of Phase 2b 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: 2021-10-19
Enrollment: 250
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses induced by vaccination with one dose of the Phase 3 clinical trial material (CTM) compared with one dose of the Phase 2b CTM.


Eligibility criteria: Inclusion Criteria:

* Willing and able to adhere to the prohibitions and restrictions specified in the protocol
* Before randomization, a participant 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
* In the investigator's clinical judgment, 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 willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
* From the time of vaccination through 3 months after vaccination, agrees not to donate blood

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 condition or medication
* History of acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy
* History of thrombosis with thrombocytopenia syndrome (TTS) or heparin-induced thrombocytopenia and thrombosis (HITT)
* 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

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: 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 Day 28 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)
measure: Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at 14 Days Post Vaccination
timeFrame: 14 days post vaccination on Day 1 (Day 15)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Diego
country: United States
facility: Optimal Research
state: California
city: Lakeland
country: United States
facility: Accel Research Sites
state: Florida
city: Melbourne
country: United States
facility: Optimal Research
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic Inc
state: Florida
city: Miami
country: United States
facility: Research Institute of South Florida Inc
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Cincinnati
country: United States
facility: Meridian Clinical Research, LLC
state: Ohio
city: San Antonio
country: United States
facility: Tekton Research Inc.
state: Texas
Study officials:
affiliation: Janssen Vaccines & Prevention B.V.
name: Janssen Vaccines & Prevention B.V. Clinical Trial
role: STUDY_DIRECTOR
References: