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

A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study for Safety and Immunogenicity Evaluations of Various RSV.preF-based Vaccine Formulations in Adults Aged 60 Years and Older

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.

Study Overview

• Status: Terminated
• Conditions: Respiratory Syncytial Virus-associated Lower Respiratory Tract Disease Prevention
• Intervention / Treatment: Biological: RSV preF-based Vaccine; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90815
      • ARK Clinical Research
  • Florida
    • DeLand, Florida, United States, 32720
      • Accel Research Sites
    • Miami Lakes, Florida, United States, 33016
      • Floridian Clinical Research LLC
  • Kansas
    • Wichita, Kansas, United States, 67207
      • Heartland Research Associates, an AMR Company
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Clinical Trials Management, LLC
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • The Center for Pharmaceutical Research (CPR)
  • Ohio
    • Cincinnati, Ohio, United States, 45246
      • Meridian Clinical Research, LLC
    • Cincinnati, Ohio, United States, 45212
      • CTI Clinical Trial and Consulting Services
  • South Carolina
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
  • Texas
    • Austin, Texas, United States, 78745
      • Tekton Research Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

19

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: RSV preF-based Vaccine; RSV preF-based vaccine will be administered as intramuscular injection.
Experimental: 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.	Biological: RSV preF-based Vaccine; RSV preF-based vaccine will be administered as intramuscular injection.
Experimental: 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.	Drug: Placebo; Placebo will be administered as intramuscular injection.
Experimental: 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.	Biological: RSV preF-based Vaccine; RSV preF-based vaccine will be administered as intramuscular injection.
Experimental: 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.	Biological: RSV preF-based Vaccine; RSV preF-based vaccine will be administered as intramuscular injection.
Experimental: 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.	Biological: RSV preF-based Vaccine; RSV preF-based vaccine will be administered as intramuscular injection.
Experimental: 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.	Biological: RSV preF-based Vaccine; RSV preF-based vaccine will be administered as intramuscular injection.
Experimental: 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.	Biological: RSV preF-based Vaccine; RSV preF-based vaccine will be administered as intramuscular injection.
Experimental: 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.	Biological: RSV preF-based Vaccine; RSV preF-based vaccine will be administered as intramuscular injection.
Experimental: 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.	Biological: RSV preF-based Vaccine; RSV preF-based vaccine will be administered as intramuscular injection.
Experimental: 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.	Biological: RSV preF-based Vaccine; RSV preF-based vaccine will be administered as intramuscular injection.
Experimental: 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.	Biological: RSV preF-based Vaccine; RSV preF-based vaccine will be administered as intramuscular injection.
Experimental: 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.	Biological: RSV preF-based Vaccine; RSV preF-based vaccine will be administered as intramuscular injection.; Drug: Placebo; Placebo will be administered as intramuscular injection.
Experimental: 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.	Biological: RSV preF-based Vaccine; RSV preF-based vaccine will be administered as intramuscular injection.; Drug: Placebo; Placebo will be administered as intramuscular injection.
Experimental: 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.	Biological: RSV preF-based Vaccine; RSV preF-based vaccine will be administered as intramuscular injection.; Drug: Placebo; Placebo will be administered as intramuscular injection.
Experimental: 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.	Biological: RSV preF-based Vaccine; RSV preF-based vaccine will be administered as intramuscular injection.; Drug: Placebo; Placebo will be administered as intramuscular injection.
Experimental: 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.	Biological: RSV preF-based Vaccine; RSV preF-based vaccine will be administered as intramuscular injection.
Experimental: 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.	Biological: RSV preF-based Vaccine; RSV preF-based vaccine will be administered as intramuscular injection.; Drug: Placebo; Placebo will be administered as intramuscular injection.
Experimental: 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.	Biological: RSV preF-based Vaccine; RSV preF-based vaccine will be administered as intramuscular injection.; Drug: Placebo; Placebo will be administered as intramuscular injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Serious Adverse Events (SAEs)	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.	From Day 1 up to 6 months post vaccination (up to Day 183)
Number of Participants With Adverse Events of Special Interest (AESIs)	Number of participants with AESIs were reported. Thrombosis with thrombocytopenia syndrome (TTS) were considered as potential AESIs.	From Day 1 up to 6 months post vaccination (up to Day 183)
Number of Participants With Solicited Local and Systemic Adverse Events (AEs)	Number of participants with solicited local and systemic AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Solicited systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).	7 days post vaccination (Day 8)
Number of Participants With Unsolicited Adverse Events (AEs)	Number of participants with unsolicited AEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant were not specifically questioned in the participant diary.	28 days post vaccination (Day 29)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort 2: RSV Fusion Protein (F Protein) Binding Antibodies as Assessed by Enzyme-Linked Immunosorbent assay (ELISA)	Antibodies binding to RSV F protein in pre-fusion (pre-F) and/or post-fusion (post-F) form will be assessed by ELISA.	Up to Day 1095
Cohort 2: Interferon Gamma (IFN-gamma) Enzyme-Linked Immunospot (ELISpot) Assay	IFN-gamma ELISpot assay will be performed to assess T-cell IFN-gamma responses to RSV F protein peptides.	Up to Day 1095
Cohort 3: Respiratory Syncytial Virus (RSV) Neutralizing Antibody Levels	RSV Neutralizing Antibody Levels will be reported	Up to Day 1095
Cohort 4: Number of Participants With Serious Adverse Events (SAEs)	An SAE is an adverse event (AE) resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.	Up to Day 1095
Cohort 4: Number of participants with AESI	Number of participants with AESIs will be reported.	Up to 6 months after vaccination (Up to Day 181)
Cohort 4: Number of Participants With Solicited Local Adverse Events (AEs)	Number of participants with solicited local AEs were reported. Solicited local AE's included pain/tenderness, erythema, and induration/swelling.	Up to 7 days after vaccination on Day 1 (up to Day 8) and Up to 7 days after re-vaccination
Cohort 4: Percentage of Participants with Systemic AEs	Number of participants with solicited systemic AEs were reported. Solicited systemic AEs included headache, fatigue, myalgia, arthralgia, chills, and fever.	Up to 7 days after vaccination on Day 1 (up to Day 8) and up to 7 days after re-vaccination
Cohort 4: Number of Participants With Unsolicited AEs	Number of participants with unsolicited AEs were reported. Unsolicited AEs included all AEs for which the participant was not specifically questioned in the participant diary	Up to 28 days after vaccination on Day 1 (up to Day 29) and Up to 28 days after re-vaccination

Collaborators and Investigators

• Sponsor: Janssen Vaccines & Prevention B.V.
• Investigators: Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial, Janssen Vaccines & Prevention B.V.

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2022
• Primary Completion (Actual): January 16, 2023
• Study Completion (Actual): February 14, 2023

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases
• Other Study ID Numbers: CR109184; VAC18195RSV1001 (Other Identifier: Janssen Vaccines & Prevention B.V.); 2022-001015-14 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No