Clinical trial NCT05327816: A Study of Various Respiratory Syncytial Virus (RSV) Pre-Fusion (preF)-Based Vaccine Formulations in Adults Aged 60 Years and Older
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Respiratory Syncytial Virus-associated Lower Respiratory Tract Disease Prevention
Lead sponsor: Janssen Vaccines & Prevention B.V.
Sponsor class: INDUSTRY
First posted: 2022-04-14
Enrollment: 132
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to 6 months post vaccination (up to Day 183)
measure: Number of Participants With Adverse Events of Special Interest (AESIs)
timeFrame: From Day 1 up to 6 months post vaccination (up to Day 183)
measure: Number of Participants With Solicited Local and Systemic Adverse Events (AEs)
timeFrame: 7 days post vaccination (Day 8)
measure: Number of Participants With Unsolicited Adverse Events (AEs)
timeFrame: 28 days post vaccination (Day 29)
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Ark Clinical Research
state: California
city: DeLand
country: United States
facility: Accel Research Sites
state: Florida
city: Miami Lakes
country: United States
facility: Floridian Clinical Research LLC
state: Florida
city: Wichita
country: United States
facility: Heartland Research Associates, an AMR Company
state: Kansas
city: Metairie
country: United States
facility: Clinical Trials Management, LLC
state: Louisiana
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research (CPR)
state: Missouri
city: Cincinnati
country: United States
facility: CTI Clinical Trial and Consulting Services
state: Ohio
city: Cincinnati
country: United States
facility: Meridian Clinical Research, LLC
state: Ohio
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Knoxville
country: United States
facility: AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
state: Tennessee
city: Austin
country: United States
facility: Tekton Research Inc.
state: Texas
Study officials:
affiliation: Janssen Vaccines & Prevention B.V.
name: Janssen Vaccines & Prevention B.V. Clinical Trial
role: STUDY_DIRECTOR
References: