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

Janssen (J&J Innovative Medicine)

Status and phase: Terminated; Phase 2; Phase 1

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

Treatments: Biological: RSV preF-based Vaccine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05327816

CR109184

VAC18195RSV1001 (Other Identifier)

2022-001015-14 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 19 patient groups

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

Experimental group

Description:

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.

Treatment:

Biological: RSV preF-based Vaccine

Arm 1b: RSV preF Based Vaccine

Experimental group

Description:

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.

Treatment:

Biological: RSV preF-based Vaccine

Arm 1c: Placebo

Experimental group

Description:

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

Treatment:

Drug: Placebo

Arm 2: RSV preF Based Vaccine

Experimental group

Description:

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.

Treatment:

Biological: RSV preF-based Vaccine

Arm 3: RSV preF Based Vaccine

Experimental group

Description:

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.

Treatment:

Biological: RSV preF-based Vaccine

Arm 4: RSV preF Based Vaccine

Experimental group

Description:

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.

Treatment:

Biological: RSV preF-based Vaccine

Arm 5: RSV preF Based Vaccine

Experimental group

Description:

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.

Treatment:

Biological: RSV preF-based Vaccine

Arm 6: RSV preF Based Vaccine

Experimental group

Description:

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.

Treatment:

Biological: RSV preF-based Vaccine

Arm 7: RSV preF Based Vaccine

Experimental group

Description:

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.

Treatment:

Biological: RSV preF-based Vaccine

Arm 8: RSV preF Based Vaccine

Experimental group

Description:

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.

Treatment:

Biological: RSV preF-based Vaccine

Arm 9: RSV preF Based Vaccine

Experimental group

Description:

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.

Treatment:

Biological: RSV preF-based Vaccine

Arm 10: RSV preF Based Vaccine

Experimental group

Description:

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.

Treatment:

Biological: RSV preF-based Vaccine

Arm 11a: RSV preF Based Vaccine and Placebo

Experimental group

Description:

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.

Treatment:

Biological: RSV preF-based Vaccine

Drug: Placebo

Arm 11b: RSV preF Based Vaccine and Placebo

Experimental group

Description:

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.

Treatment:

Biological: RSV preF-based Vaccine

Drug: Placebo

Arm 12: RSV preF Based Vaccine and Placebo

Experimental group

Description:

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.

Treatment:

Biological: RSV preF-based Vaccine

Drug: Placebo

Arm 13: RSV preF Based Vaccine

Experimental group

Description:

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

Treatment:

Biological: RSV preF-based Vaccine

Drug: Placebo

Arm 14: RSV preF Based Vaccine

Experimental group

Description:

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.

Treatment:

Biological: RSV preF-based Vaccine

Arm 15: RSV preF Based Vaccine and Placebo

Experimental group

Description:

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.

Treatment:

Biological: RSV preF-based Vaccine

Drug: Placebo

Arm 16: RSV preF Based Vaccine and Placebo

Experimental group

Description:

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.

Treatment:

Biological: RSV preF-based Vaccine

Drug: Placebo