A Study of Various Respiratory Syncytial Virus (RSV) Pre-Fusion (preF)-Based Vaccine Formulations in Adults Aged 60 Years and Older

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Respiratory Syncytial Virus-associated Lower Respiratory Tract Disease Prevention

In brief

The purpose of the study is to evaluate safety and immunogenicity of various respiratory syncytial virus (RSV) pre-Fusion (preF)-based vaccine components followed by expanded safety evaluation and durability/revaccination evaluation of the selected RSV preF-based vaccine formulation in participants aged greater than or equal to (\>=) 60 years in stable health.

Key facts

Study ID: NCT05327816
Run by: Janssen Vaccines & Prevention B.V.
People needed: 132
Starts: 2022-04-13
Expected to finish: 2023-02-14
Last updated by the study team: 2025-05-25

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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 (COPD), Type 2 diabetes mellitus, 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 physical examination, medical history, and vital signs performed between informed consent form (ICF) signature and vaccination
For participants in Cohorts 1 and 2 only: Participant must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the laboratory normal reference ranges and additionally within the limits of toxicity Grade 2 according to the United States Food and Drug Administration (US FDA) toxicity tables (that is, for tests in the FDA table), the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
Agrees not to donate blood from the time of vaccination through 3 months after vaccination
Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study

You may not qualify if…

History of malignancy within 5 years before screening not in the following categories: a) Participants with squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix may be enrolled at the discretion of the investigator; b) Participants with a history of malignancy within 5 years before screening, with minimal risk of recurrence per investigator's judgment, can be enrolled
Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components
Per medical history, participant has chronic active hepatitis B or hepatitis C infection, human immunodeficiency viruses (HIV) type 1 or type 2 infection, acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy
Participant is in receipt of, or planning to receive, licensed live attenuated vaccine within 28 days before and after study vaccinations; other licensed vaccines (that is, not live such as, influenza, tetanus, hepatitis A or B, rabies) within 14 days before and after study vaccinations
Received treatment with immunoglobulins expected to impact the vaccine-induced immune response (including monoclonal antibodies [MAbs] for chronic underlying conditions) in the 2 months; immunoglobulins specific to respiratory syncytial virus (RSV), human metapneumovirus, or parainfluenza viruses in the 12 months; apheresis therapies in the 4 months; or blood products in the 4 months prior to study vaccination or has any plans to receive such treatment during the study

Where it is running

Ark Clinical Research — Long Beach, California, United States
Accel Research Sites — DeLand, Florida, United States
Floridian Clinical Research LLC — Miami Lakes, Florida, United States
Heartland Research Associates, an AMR Company — Wichita, Kansas, United States
Clinical Trials Management, LLC — Metairie, Louisiana, United States
The Center for Pharmaceutical Research (CPR) — Kansas City, Missouri, United States
CTI Clinical Trial and Consulting Services — Cincinnati, Ohio, United States
Meridian Clinical Research, LLC — Cincinnati, Ohio, United States
Coastal Carolina Research Center — North Charleston, South Carolina, United States
AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company — Knoxville, Tennessee, United States
Tekton Research Inc. — Austin, Texas, United States

Full record on ClinicalTrials.gov

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