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

NCT ID: NCT05327816

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-13
• Study Completion Date: 2023-02-14

Brief Summary

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.

Detailed Description

RSV is an important cause of serious respiratory infections in adults aged 60 years and older. The current study is divided into four cohorts, evaluating various doses and combinations of RSV preF-based vaccines. Cohort 1 will assess the safety and reactogenicity of different RSV preF-based vaccines. Cohort 2 is an expansion of cohort 1 and will assess both safety and immunogenicity of these different RSV vaccines. based on C1 and 2 data the optimal vaccine composition will be selected and further evaluated in Cohort 3 and 4 including durability and revaccination. Cohort 3 will accumulate safety data on the selected vaccine and optimize its formulation. Cohort 4 is an expansion of several arms in cohort 3, aimed to understand the durability of the immune response induced by the selected vaccine, and to explore the possibility for revaccination.

Conditions

Respiratory Syncytial Virus-associated Lower Respiratory Tract Disease Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Arm 1a: Respiratory Syncytial Virus (RSV) preFusion (preF) Based Vaccine

Participants will receive single dose of mixture of RSV preF-based vaccine in cohort (C) 1 (Group \[G\] 1) and C 2 through intramuscular injection on Day 1.

Group Type: EXPERIMENTAL

RSV preF-based Vaccine

Intervention Type: BIOLOGICAL

RSV preF-based vaccine will be administered as intramuscular injection.

Arm 1b: RSV preF Based Vaccine

Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 1-4) and C 2 through intramuscular injection on Day 1.

Group Type: EXPERIMENTAL

RSV preF-based Vaccine

Intervention Type: BIOLOGICAL

RSV preF-based vaccine will be administered as intramuscular injection.

Arm 1c: Placebo

Participants will receive single dose of placebo in C 1 (G 1-4) and C 2 through intramuscular injection on Day 1.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Placebo will be administered as intramuscular injection.

Arm 2: RSV preF Based Vaccine

Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 2) and C 2 through intramuscular injection on Day 1.

Group Type: EXPERIMENTAL

RSV preF-based Vaccine

Intervention Type: BIOLOGICAL

RSV preF-based vaccine will be administered as intramuscular injection.

Arm 3: RSV preF Based Vaccine

Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 2) and C 2 through intramuscular injection on Day 1.

Group Type: EXPERIMENTAL

RSV preF-based Vaccine

Intervention Type: BIOLOGICAL

RSV preF-based vaccine will be administered as intramuscular injection.

Arm 4: RSV preF Based Vaccine

Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 2) and C 2 through intramuscular injection on Day 1.

Group Type: EXPERIMENTAL

RSV preF-based Vaccine

Intervention Type: BIOLOGICAL

RSV preF-based vaccine will be administered as intramuscular injection.

Arm 5: RSV preF Based Vaccine

Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 2) and C 2 through intramuscular injection on Day 1.

Group Type: EXPERIMENTAL

RSV preF-based Vaccine

Intervention Type: BIOLOGICAL

RSV preF-based vaccine will be administered as intramuscular injection.

Arm 6: RSV preF Based Vaccine

Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 2) and C 2 through intramuscular injection on Day 1.

Group Type: EXPERIMENTAL

RSV preF-based Vaccine

Intervention Type: BIOLOGICAL

RSV preF-based vaccine will be administered as intramuscular injection.

Arm 7: RSV preF Based Vaccine

Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 3) and C 2 through intramuscular injection on Day 1.

Group Type: EXPERIMENTAL

RSV preF-based Vaccine

Intervention Type: BIOLOGICAL

RSV preF-based vaccine will be administered as intramuscular injection.

Arm 8: RSV preF Based Vaccine

Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 3) and C 2 through intramuscular injection on Day 1.

Group Type: EXPERIMENTAL

RSV preF-based Vaccine

Intervention Type: BIOLOGICAL

RSV preF-based vaccine will be administered as intramuscular injection.

Arm 9: RSV preF Based Vaccine

Participants will receive single dose of mixture of RSV preF-based vaccine in C 1 (G 4) and C 2 through intramuscular injection on Day 1.

Group Type: EXPERIMENTAL

RSV preF-based Vaccine

Intervention Type: BIOLOGICAL

RSV preF-based vaccine will be administered as intramuscular injection.

Arm 10: RSV preF Based Vaccine

Participants will receive a single dose of selected formulation (based on C 1 and 2 results) in C 3 through intramuscular injection on Day 1.

Group Type: EXPERIMENTAL

RSV preF-based Vaccine

Intervention Type: BIOLOGICAL

RSV preF-based vaccine will be administered as intramuscular injection.

Arm 11a: RSV preF Based Vaccine and Placebo

Participants in C 3 will receive a single dose of first vaccination with selected formulation (as per data C1 and 2) plus placebo on Day 1 and re-vaccination with selected formulation whenever revaccination would be needed through intramuscular injection.

Group Type: EXPERIMENTAL

RSV preF-based Vaccine

Intervention Type: BIOLOGICAL

RSV preF-based vaccine will be administered as intramuscular injection.

Placebo

Intervention Type: DRUG

Placebo will be administered as intramuscular injection.

Arm 11b: RSV preF Based Vaccine and Placebo

Participants in C 3 will receive a single dose of first vaccination with selected formulation (as per data from C 1 and 2) plus placebo on Day 1 and re-vaccination with placebo whenever revaccination would be needed through intramuscular injection.

Group Type: EXPERIMENTAL

RSV preF-based Vaccine

Intervention Type: BIOLOGICAL

RSV preF-based vaccine will be administered as intramuscular injection.

Placebo

Intervention Type: DRUG

Placebo will be administered as intramuscular injection.

Arm 12: RSV preF Based Vaccine and Placebo

Participants in C 3 will receive first vaccination with placebo on Day 1 and re-vaccination with selected formulation (as per data from C 1 and 2) whenever revaccination would be needed through intramuscular injection.

Group Type: EXPERIMENTAL

RSV preF-based Vaccine

Intervention Type: BIOLOGICAL

RSV preF-based vaccine will be administered as intramuscular injection.

Placebo

Intervention Type: DRUG

Placebo will be administered as intramuscular injection.

Arm 13: RSV preF Based Vaccine

Participants in C 3 will receive the mixture of RSV preF-based vaccine plus placebo on Day 1 through intramuscular injection.

Group Type: EXPERIMENTAL

RSV preF-based Vaccine

Intervention Type: BIOLOGICAL

RSV preF-based vaccine will be administered as intramuscular injection.

Placebo

Intervention Type: DRUG

Placebo will be administered as intramuscular injection.

Arm 14: RSV preF Based Vaccine

Participants in C 4 will receive first vaccination with selected formulation (as per data from C 1 and 2) on Day 1 and re-vaccination with selected formulation whenever revaccination would be needed through intramuscular injection.

Group Type: EXPERIMENTAL

RSV preF-based Vaccine

Intervention Type: BIOLOGICAL

RSV preF-based vaccine will be administered as intramuscular injection.

Arm 15: RSV preF Based Vaccine and Placebo

Participants in C 4 will receive first vaccination with selected formulation (as per data from C 1 and 2) on Day 1 and re-vaccination with placebo whenever revaccination would be needed through intramuscular injection.

Group Type: EXPERIMENTAL

RSV preF-based Vaccine

Intervention Type: BIOLOGICAL

RSV preF-based vaccine will be administered as intramuscular injection.

Placebo

Intervention Type: DRUG

Placebo will be administered as intramuscular injection.

Arm 16: RSV preF Based Vaccine and Placebo

Participants in C 4 will receive first vaccination with placebo on Day 1 and re-vaccination with selected formulation (as per data from C 1 and 2) whenever revaccination would be needed through intramuscular injection.

Group Type: EXPERIMENTAL

RSV preF-based Vaccine

Intervention Type: BIOLOGICAL

RSV preF-based vaccine will be administered as intramuscular injection.

Placebo

Intervention Type: DRUG

Placebo will be administered as intramuscular injection.

Interventions

RSV preF-based Vaccine

RSV preF-based vaccine will be administered as intramuscular injection.

Intervention Type: BIOLOGICAL

Placebo

Placebo will be administered as intramuscular injection.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Vaccines & Prevention B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Vaccines & Prevention B.V. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Vaccines & Prevention B.V.

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

VAC18195RSV1001

Identifier Type: OTHER

Identifier Source: secondary_id

2022-001015-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR109184

Identifier Type: -

Identifier Source: org_study_id