Study Stopped
Based on recent study data from VAC18193, it was decided to terminate the study. There are no underlying safety concerns to terminate VAC18195RSV1001
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
3 other identifiers
interventional
132
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2022
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2022
CompletedStudy Start
First participant enrolled
April 13, 2022
CompletedFirst Posted
Study publicly available on registry
April 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2023
CompletedResults Posted
Study results publicly available
January 2, 2024
CompletedMay 25, 2025
May 1, 2025
9 months
April 13, 2022
December 12, 2023
May 22, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
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)
Study Arms (19)
Arm 1a: Respiratory Syncytial Virus (RSV) preFusion (preF) Based Vaccine
EXPERIMENTALParticipants 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.
Arm 1b: RSV preF Based Vaccine
EXPERIMENTALParticipants 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.
Arm 1c: Placebo
EXPERIMENTALParticipants will receive single dose of placebo in C 1 (G 1-4) and C 2 through intramuscular injection on Day 1.
Arm 2: RSV preF Based Vaccine
EXPERIMENTALParticipants 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.
Arm 3: RSV preF Based Vaccine
EXPERIMENTALParticipants 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.
Arm 4: RSV preF Based Vaccine
EXPERIMENTALParticipants 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.
Arm 5: RSV preF Based Vaccine
EXPERIMENTALParticipants 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.
Arm 6: RSV preF Based Vaccine
EXPERIMENTALParticipants 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.
Arm 7: RSV preF Based Vaccine
EXPERIMENTALParticipants 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.
Arm 8: RSV preF Based Vaccine
EXPERIMENTALParticipants 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.
Arm 9: RSV preF Based Vaccine
EXPERIMENTALParticipants 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.
Arm 10: RSV preF Based Vaccine
EXPERIMENTALParticipants will receive a single dose of selected formulation (based on C 1 and 2 results) in C 3 through intramuscular injection on Day 1.
Arm 11a: RSV preF Based Vaccine and Placebo
EXPERIMENTALParticipants 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.
Arm 11b: RSV preF Based Vaccine and Placebo
EXPERIMENTALParticipants 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.
Arm 12: RSV preF Based Vaccine and Placebo
EXPERIMENTALParticipants 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.
Arm 13: RSV preF Based Vaccine
EXPERIMENTALParticipants in C 3 will receive the mixture of RSV preF-based vaccine plus placebo on Day 1 through intramuscular injection.
Arm 14: RSV preF Based Vaccine
EXPERIMENTALParticipants 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.
Arm 15: RSV preF Based Vaccine and Placebo
EXPERIMENTALParticipants 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.
Arm 16: RSV preF Based Vaccine and Placebo
EXPERIMENTALParticipants 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.
Interventions
RSV preF-based vaccine will be administered as intramuscular injection.
Placebo will be administered as intramuscular injection.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Ark Clinical Research
Long Beach, California, 90815, United States
Accel Research Sites
DeLand, Florida, 32720, United States
Floridian Clinical Research LLC
Miami Lakes, Florida, 33016, United States
Heartland Research Associates, an AMR Company
Wichita, Kansas, 67207, United States
Clinical Trials Management, LLC
Metairie, Louisiana, 70006, United States
The Center for Pharmaceutical Research (CPR)
Kansas City, Missouri, 64114, United States
CTI Clinical Trial and Consulting Services
Cincinnati, Ohio, 45212, United States
Meridian Clinical Research, LLC
Cincinnati, Ohio, 45246, United States
Coastal Carolina Research Center
North Charleston, South Carolina, 29405, United States
AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
Knoxville, Tennessee, 37920, United States
Tekton Research Inc.
Austin, Texas, 78745, United States
Limitations and Caveats
Study was terminated on sponsor's decision, hence, participants were enrolled in Cohort 1 only. Cohorts 2, 3, and 4 were not initiated. Participants enrolled in Cohort 1 completed visit up to Day 183 (6-months post vaccination) and safety evaluations were performed only for Cohort 1. Since the study was terminated prior to Cohort 2 enrolment and the data was planned for combined Cohorts 1 and 2, samples collected in Cohort 1 alone were not tested and no immunogenicity testing was performed.
Results Point of Contact
- Title
- Medical Leader
- Organization
- Janssen Vaccines & Prevention B.V.
Study Officials
- STUDY DIRECTOR
Janssen Vaccines & Prevention B.V. Clinical Trial
Janssen Vaccines & Prevention B.V.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2022
First Posted
April 14, 2022
Study Start
April 13, 2022
Primary Completion
January 16, 2023
Study Completion
February 14, 2023
Last Updated
May 25, 2025
Results First Posted
January 2, 2024
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
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