A Study of an Ad26.RSV. preF-based Vaccine in Adults Aged 18 to 59 Years, Including Adults at High Risk for Severe RSV Infection
NCT ID: NCT05070546
Last Updated: 2025-05-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1124 participants
INTERVENTIONAL
2021-09-29
2022-08-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Cohort (C)1 Group (G)1: Healthy Adults, 18-59 Years (Respiratory Syncytial Virus [RSV] vaccine)
Participants will receive a single intramuscular (IM) injection of study vaccine on Day 1.
Ad26.RSV.preF-based Vaccine
Participants will receive a single IM injection of an RSV vaccine.
C1 G2: Healthy Adults, 18-59 Years (Placebo)
Participants will receive a single IM injection of matching placebo on Day 1.
Placebo
Participants will receive a single IM injection of matching placebo.
C2 G3: High Risk Adult, 18-59 Years (RSV Vaccine)
Participants will receive a single IM injection of study vaccine on Day 1.
Ad26.RSV.preF-based Vaccine
Participants will receive a single IM injection of an RSV vaccine.
C2 G4: High Risk Adult, 18-59 Years (Placebo)
Participants will receive a single IM injection of matching placebo on Day 1.
Placebo
Participants will receive a single IM injection of matching placebo.
C3 G5: Adults, 65 Years and Older (RSV Vaccine)
Participants will receive a single IM injection of study vaccine on Day 1.
Ad26.RSV.preF-based Vaccine
Participants will receive a single IM injection of an RSV vaccine.
C3 G6: Adults, 65 Years and Older (Placebo)
Participants will receive a single IM injection of matching placebo on Day 1.
Placebo
Participants will receive a single IM injection of matching placebo.
Interventions
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Ad26.RSV.preF-based Vaccine
Participants will receive a single IM injection of an RSV vaccine.
Placebo
Participants will receive a single IM injection of matching placebo.
Eligibility Criteria
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Inclusion Criteria
* All participants of childbearing potential must: have a negative highly sensitive urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening; and have a negative highly sensitive urine beta-hCG pregnancy test immediately prior to each study vaccination (if screening and vaccination are not performed on the same day) Cohorts 1 and 2
* Participant is aged 18 to 59 years (inclusive) on the day of signing the informed consent form (ICF) and expected to be available for the duration of the study Cohort 2
* Has an existing chronic heart or lung condition, without hospitalizations or major medication class change (that is, new or stopped medications) within 30 days prior to screening, meeting the following criteria; a) cardiac disease: at least Class II symptoms per New York Heart Association classification or similar guidelines according to local practice, b) pulmonary disease: activity-restricting symptoms or use of long-term medications Cohort 3
* Participant is aged 65 years or older on the day of signing the ICF and expected to be available for the duration of the study
* Participant may have underlying illnesses such as hypertension, congestive heart failure, chronic obstructive pulmonary disease (COPD), 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
Exclusion Criteria
* Abnormal function of immune system due to a clinical condition or treatment
* History of thrombosis with thrombocytopenia syndrome (TTS) or heparin-induced thrombocytopenia and thrombosis (HITT).
* Participant received or plans to receive: (a) licensed live attenuated vaccines - within 28 days before or after planned administration of study vaccine; and (b) other licensed (not live) vaccines - within 14 days before or after planned administration of study vaccine
* Received an respiratory syncytial virus (RSV) vaccine in a previous RSV vaccine study
* History of acute polyneuropathy (example, Guillain-Barre syndrome) or chronic idiopathic demyelinating polyneuropathy
18 Years
ALL
Yes
Sponsors
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Janssen Vaccines & Prevention B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Vaccines & Prevention B.V. Clinical Trial
Role: STUDY_DIRECTOR
Janssen Vaccines & Prevention B.V.
Locations
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Alliance for Multispeciality Research
Coral Gables, Florida, United States
Research Institute of South Florida Inc
Miami, Florida, United States
Heartland Research Associates, an AMR Company
El Dorado, Kansas, United States
AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
New Orleans, Louisiana, United States
Meridian Clinical Research, LLC
Rockville, Maryland, United States
Tekton Research Inc.
Yukon, Oklahoma, United States
Alliance for Multispeciality Research
Knoxville, Tennessee, United States
Anima
Alken, , Belgium
C.H.U. St Pierre / Maladies Infectieuses
Brussels, , Belgium
Private Practice RESPISOM Namur
Namur, , Belgium
Emovis GmbH
Berlin, , Germany
Klinische Forschung Berlin GbR
Berlin, , Germany
Zentrum fuer klinische Forschung
Cologne, , Germany
Klinische Forschung Dresden GmbH
Dresden, , Germany
Clinical Research HamburggmbH
Hamburg, , Germany
SIBAmed GmbH & Co. KG
Leipzig, , Germany
Klinische Forschung Schwerin GmbH
Schwerin, , Germany
Hosp Reina Sofia
Córdoba, , Spain
Hosp Virgen de La Victoria
Málaga, , Spain
ProbarE i Lund AB
Lund, , Sweden
ClinSmart Sweden AB
Solna, , Sweden
ProbarE i Stockholm AB
Stockholm, , Sweden
Studieenheten Akademiskt Specialistcentrum Stockholm
Stockholm, , Sweden
Countries
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References
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LaRoche JK, Lanier J, Alvarenga R, Collins M, Costelloe T, Chiau A, Whetherly H, De Soete W, Faludi J, Rens K. Climate footprint of industry-sponsored in-human clinical trials: life cycle assessments of clinical trials spanning multiple phases and disease areas. BMJ Open. 2025 Feb 19;15(2):e085364. doi: 10.1136/bmjopen-2024-085364.
Jastorff A, Gymnopoulou E, Salas J, Merrall E, Buntinx E, Martin C, Askling HH, Schenkenberger I, Yuste AC, Smith W, Sotolongo R, Von Engelhardt C, Bastian AR, Comeaux C, Ligtenberg N, Callendret B, Heijnen E. Safety and immunogenicity of the Ad26/protein preF RSV vaccine in adults aged 18 to 59 years with and without at-risk comorbidities for severe respiratory syncytial virus disease: A phase 3, randomized, controlled, immunobridging trial. Vaccine. 2025 Jan 1;43(Pt 1):126514. doi: 10.1016/j.vaccine.2024.126514. Epub 2024 Nov 12.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2021-001909-77
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VAC18193RSV3006
Identifier Type: OTHER
Identifier Source: secondary_id
CR109038
Identifier Type: -
Identifier Source: org_study_id
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