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

Completed · Phase 3 · Has a placebo group

Conditions studied: Respiratory Syncytial Virus Infection Prevention

In brief

The purpose of the study is to investigate the safety and immunogenicity of the Ad26.RSV.preF based vaccine in adults 18 to 59 years of age who are healthy or at risk for severe Respiratory Syncytial Virus (RSV) disease, compared to adults 65 years and above.

Key facts

Study ID

NCT05070546

Run by

Janssen Vaccines & Prevention B.V.

People needed

1124

Starts

2021-09-29

Expected to finish

2022-08-12

Last updated by the study team

2025-05-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants must be of a) non child bearing potential or b) of child bearing potential and practicing an acceptable and effective of contraception
• 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

You may not qualify if…

• 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 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

Where it is running

• Heartland Research Associates, an AMR Company — El Dorado, Kansas, United States
• Alliance for Multispeciality Research — Coral Gables, Florida, United States
• Research Institute of South Florida Inc — Miami, Florida, 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

Full record on ClinicalTrials.gov

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