Clinical trial NCT05070546: A Study of an Ad26.RSV. preF-based Vaccine in Adults Aged 18 to 59 Years, Including Adults at High Risk for Severe RSV Infection
Official title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Safety and Immunogenicity of an Ad26.RSV.preF-based Vaccine in Adults Aged 18 to 59 Years, Including Those at High-risk for Severe RSV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Syncytial Virus Infection Prevention
Lead sponsor: Janssen Vaccines & Prevention B.V.
Sponsor class: INDUSTRY
First posted: 2021-10-07
Enrollment: 1124
Sex: ALL
Minimum age (years): 18
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 investigate the safety and immunogenicity of the Ad26.RSV.preF based vaccine in adults 18 to 59 years of age who are healthy or at risk for severe Respiratory Syncytial Virus (RSV) disease, compared to adults 65 years and above.

Detailed description: RSV is an important cause of serious respiratory infections in adults aged 60 years and older, immunocompromised individuals, and those with underlying chronic cardiopulmonary conditions. The current study assess the safety and immunogenicity of the RSV vaccine in adults 18 to 59 years of age, including those who are at risk for severe RSV disease. The study comprises screening (pre-vaccination) and vaccination for each participant on Day 1, and a 6- month safety and immunogenicity follow-up period. The study duration will be up to 6 months per participant. Assessments like immunogenicity (such as humoral and cellular immune responses), safety (such as monitoring of AEs, physical examinations, and vital signs) and reactogenicity will be performed in this study.

Eligibility criteria: Inclusion Criteria:

* Participants must be of a) non child bearing potential or b) of child bearing potential and practicing an acceptable and effective of contraception
* All participants of childbearing potential must: have a negative highly sensitive urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening; and have a negative highly sensitive urine beta-hCG pregnancy test immediately prior to each study vaccination (if screening and vaccination are not performed on the same day) Cohorts 1 and 2
* Participant is aged 18 to 59 years (inclusive) on the day of signing the informed consent form (ICF) and expected to be available for the duration of the study Cohort 2
* Has an existing chronic heart or lung condition, without hospitalizations or major medication class change (that is, new or stopped medications) within 30 days prior to screening, meeting the following criteria; a) cardiac disease: at least Class II symptoms per New York Heart Association classification or similar guidelines according to local practice, b) pulmonary disease: activity-restricting symptoms or use of long-term medications Cohort 3
* Participant is aged 65 years or older on the day of signing the ICF and expected to be available for the duration of the study
* Participant may have underlying illnesses such as hypertension, congestive heart failure, chronic obstructive pulmonary disease (COPD), type 2 diabetes, 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

Exclusion Criteria:

* Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
* Abnormal function of immune system due to a clinical condition or treatment
* History of thrombosis with thrombocytopenia syndrome (TTS) or heparin-induced thrombocytopenia and thrombosis (HITT).
* Participant received or plans to receive: (a) licensed live attenuated vaccines - within 28 days before or after planned administration of study vaccine; and (b) other licensed (not live) vaccines - within 14 days before or after planned administration of study vaccine
* Received an respiratory syncytial virus (RSV) vaccine in a previous RSV vaccine study
* History of acute polyneuropathy (example, Guillain-Barre syndrome) or chronic idiopathic demyelinating polyneuropathy

Primary outcomes:
measure: Cohorts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs)
timeFrame: 7 days after vaccination on Day 1 (Day 8)
measure: Cohorts 1 and 2: Number of Participants With Solicited Systemic AEs
timeFrame: 7 days after vaccination on Day 1 (Day 8)
measure: Cohorts 1 and 2: Number of Participants With Unsolicited AEs
timeFrame: 28 days after vaccination on Day 1 (Day 29)
measure: Cohorts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: 6 months after vaccination on Day 1 (Day 183)
measure: Cohorts 1, 2, and 3: Number of Participants With Adverse Events of Special Interest (AESI)
timeFrame: 6 months after vaccination on Day 1 (Day 183)
measure: Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers
timeFrame: 14 days after vaccination on Day 1 (Day 15)
measure: Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Percentage of Participants With Seroresponse as Assessed by Virus Neutralizing Assay (VNA-A2)
timeFrame: 14 days after vaccination on Day 1 (Day 15)
Secondary outcomes:
measure: Cohorts 1, 2, and 3: Geomteric Mean Titers (GMTs) of RSV Fusion Protein (F-protein) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)- Pre-Fusion
timeFrame: 14 days after vaccination on Day 1 (Day 15)
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Alliance for Multispeciality Research
state: Florida
city: Miami
country: United States
facility: Research Institute of South Florida Inc
state: Florida
city: El Dorado
country: United States
facility: Heartland Research Associates, an AMR Company
state: Kansas
city: New Orleans
country: United States
facility: AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
state: Louisiana
city: Rockville
country: United States
facility: Meridian Clinical Research, LLC
state: Maryland
city: Yukon
country: United States
facility: Tekton Research Inc.
state: Oklahoma
city: Knoxville
country: United States
facility: Alliance for Multispeciality Research
state: Tennessee
city: Alken
country: Belgium
facility: Anima
city: Bruxelles
country: Belgium
facility: C.H.U. St Pierre / Maladies Infectieuses
city: Namur
country: Belgium
facility: Private Practice RESPISOM Namur
city: Berlin
country: Germany
facility: Emovis GmbH
city: Berlin
country: Germany
facility: Klinische Forschung Berlin GbR
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH
city: Hamburg
country: Germany
facility: Clinical Research HamburggmbH
city: Koeln
country: Germany
facility: Zentrum fuer klinische Forschung
city: Leipzig
country: Germany
facility: SIBAmed GmbH & Co. KG
city: Schwerin
country: Germany
facility: Klinische Forschung Schwerin GmbH
city: Córdoba
country: Spain
facility: Hosp Reina Sofia
city: Málaga
country: Spain
facility: Hosp Virgen de La Victoria
city: Lund
country: Sweden
facility: ProbarE i Lund AB
city: Solna
country: Sweden
facility: ClinSmart Sweden AB
city: Stockholm
country: Sweden
facility: ProbarE i Stockholm AB
city: Stockholm
country: Sweden
facility: Studieenheten Akademiskt Specialistcentrum Stockholm
Study officials:
affiliation: Janssen Vaccines & Prevention B.V.
name: Janssen Vaccines & Prevention B.V. Clinical Trial
role: STUDY_DIRECTOR
References: