Clinical trial NCT05238025: MVA-BN-RSV Vaccine Trial
Official title: A Randomized, Double-blind, Phase 3 Trial to Assess Clinical Efficacy, Safety and Reactogenicity of the Recombinant MVA-BN® -RSV Vaccine in Adults ≥60 Years of Age
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Respiratory Syncytial Virus Infections
Lead sponsor: Bavarian Nordic
Sponsor class: INDUSTRY
First posted: 2022-02-14
Enrollment: 20419
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: Phase 3 randomized, double blind study comparing recombinant MVA-BN-RSV vaccine vs placebo for efficacy and safety in adults \>=60 years of age


Eligibility criteria: Inclusion Criteria:

1. Male and female subjects ≥60 years of age.
2. Informed Consent signed by the subject.
3. Subjects may have one or more chronic medical conditions e.g., mild to moderate underlying illnesses such as chronic cardiac diseases and chronic lung disease (asthma and chronic obstructive pulmonary disease \[COPD\]), congestive heart failure (CHF), hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, that is clinically stable as assessed by the investigator.
4. Absence of known, current, and life-limiting diagnoses that render survival to completion of the protocol unlikely.
5. Ability to comply with trial requirements, which necessitates access to transportation to on-site visits, including symptom visits for a nasopharyngeal swab.
6. Willingness and ability to utilize an application on a personal device (i.e., smartphone, tablet, etc.) or a provisioned device to record solicited events and record all per protocol required data during the surveillance period.
7. For women of childbearing potential (WOCBP), agreement to use an acceptable method of contraception during the trial and a negative urine pregnancy test within 24 hours prior to vaccination.

Exclusion Criteria:

1. History of or current clinical manifestation of any serious medical condition that in the opinion of the investigator would compromise the safety of the subject, confound data interpretation, or would limit the subject's ability to complete the trial.
2. History of or active autoimmune disease, including diabetes mellitus type I. Vitiligo or hypothyroidism requiring thyroid replacement therapy are not exclusions. Rheumatoid arthritis not requiring immunomodulatory and/or immunosuppressant treatment is not an exclusion.
3. Known or suspected impairment of immunologic functions, including chronic inflammatory bowel disorders.
4. Clinically significant mental disorder that would prevent patients from giving informed consent and complying with study procedures (e.g., completion of the electronic diary).
5. Active or recent (within 6 months before enrollment) history of chronic alcohol abuse.
6. History of a serious reaction to any prior vaccination or Guillain-Barré syndrome (GBS) within 6 weeks of any prior influenza immunization.
7. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g., tris(hydroxymethyl)-amino methane, chicken embryo fibroblast proteins, gentamycin, ciprofloxacin; this includes:

   * Known allergy to eggs or aminoglycosides
   * History of anaphylaxis or severe allergic reaction to any vaccine
8. Any administration or planned administration of:

   * A licensed live or vector-based vaccine within 30 days prior to or after trial vaccine administration.
   * A licensed inactivated or ribonucleic acid (RNA)-based vaccine within 14 days prior to or after trial vaccine administration.
9. Previous vaccination with an RSV vaccine, or any planned vaccination with an RSV vaccine other than the trial vaccine.
10. Planned chronic, systemic administration (defined as more than 14 days) of \>10 mg prednisone (or equivalent)/day or any other systemic use of immunemodifying drugs during a period starting from 3 months prior to first administration of the trial vaccine and ending at the End of Study Visit (EOS). The use of topical, inhaled, ophthalmic and nasal glucocorticoids is permitted.
11. Administration or planned administration of immunoglobulins and/or any blood products during a period starting from 3 months prior to first administration of the trial vaccine and during the trial.
12. Known uncontrolled coagulation disorder. Anticoagulant treatment under adequate control for cardiovascular prophylaxis or prophylaxis of thromboembolic disease or stroke in the setting of atrial fibrillation are permitted.
13. Use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days prior to the administration of the trial vaccine, or planned administration of such a drug or vaccine between enrollment in the trial and until the end of the clinical trial including follow-up. \[For US Only\]
14. Involvement with this trial as research personnel.

Primary outcomes:
measure: Occurrence of PCR Confirmed RSV-associated LRTD With at Least 3 Symptoms
timeFrame: From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months
measure: Occurrence of PCR Confirmed RSV-associated LRTD With at Least 2 Symptoms
timeFrame: From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months
Secondary outcomes:
measure: Occurrence of PCR Confirmed RSV-associated ARD
timeFrame: From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months
measure: Occurrence of Complications Related to PCR-confirmed RSV Disease
timeFrame: From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months
measure: Occurrence of Hospitalization Due to Confirmed RSV Disease or Due to Any Complication Related to RSV-confirmed Respiratory Disease
timeFrame: From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months
measure: Occurrence of Severe PCR Confirmed RSV-associated LRTD
timeFrame: From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months
measure: Number of Participants With Serious Adverse Events
timeFrame: From vaccination through study termination, up to 16 months
measure: Number of Participants With Grade 3 or Higher Adverse Events
timeFrame: Within 29 days after vaccination
measure: Number of Participants With Solicited Local Adverse Events
timeFrame: Within 8 days after vaccination
measure: Number of Participants With Solicited Systemic Adverse Events
timeFrame: Within 8 days after vaccination
measure: Number of Participants With Unsolicited Adverse Events
timeFrame: Within 29 days after vaccination
measure: RSV-specific T-cell Responses
timeFrame: 1 week after vaccination
measure: RSV-specific Serum IgG Antibody Titers
timeFrame: 2 weeks after vaccination
measure: RSV-specific Serum Neutralizing Antibody Titers (Subtype A)
timeFrame: 2 weeks after vaccination
measure: RSV-specific Serum Neutralizing Antibody Titers (Subtype B)
timeFrame: 2 weeks after vaccination
Other outcomes:
Locations:
city: Athens
country: United States
facility: North Alabama Research Center, LLC
state: Alabama
city: Birmingham
country: United States
facility: Central Alabama Research
state: Alabama
city: Birmingham
country: United States
facility: Achieve Clinical Research, LLC d/b/a Accel Research Sites
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliation Research Center
state: Alabama
city: Glendale
country: United States
facility: Lenzmeier Family Medicine / CCT Research
state: Arizona
city: Mesa
country: United States
facility: Aventiv Research Inc.
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Clinical LLC
state: Arizona
city: Phoenix
country: United States
facility: Pain Center of Arizona
state: Arizona
city: Phoenix
country: United States
facility: Cognitive Clinical Trials, LLC
state: Arizona
city: Tempe
country: United States
facility: Fiel Family and Sports Medicine/CCT Research
state: Arizona
city: Tempe
country: United States
facility: HOPE Research Institute
state: Arizona
city: Tucson
country: United States
facility: Tucson Neuroscience Research, LLC
state: Arizona
city: Little Rock
country: United States
facility: Lynn Institute of the Ozarks
state: Arkansas
city: Canoga Park
country: United States
facility: Hope Clinical Research, LLC
state: California
city: Huntington Beach
country: United States
facility: Marvel Clinical Research 002, LLC
state: California
city: Huntington Park
country: United States
facility: Join Clinical Trials
state: California
city: La Mesa
country: United States
facility: Paradigm Clinical Research Center
state: California
city: La Palma
country: United States
facility: Atella Clinical Research LLC
state: California
city: Lancaster
country: United States
facility: Chemidox Clinical Trials Inc.
state: California
city: Long Beach
country: United States
facility: ARK Clinical Research
state: California
city: Los Angeles
country: United States
facility: Matrix Clinical Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Aurora
country: United States
facility: Lynn Institute of Denver
state: Colorado
city: Clearwater
country: United States
facility: Innovative Research Of West Florida, Inc.
state: Florida
city: Hialeah
country: United States
facility: Doral Medical Research
state: Florida
city: Maitland
country: United States
facility: K2 Medical Research, LLC
state: Florida
city: Miami Lakes
country: United States
facility: Global Health Research Center, Inc
state: Florida
city: Miami
country: United States
facility: Optimus U Corporation
state: Florida
city: Miami
country: United States
facility: De La Cruz Research Center, LLC
state: Florida
city: Pembroke Pines
country: United States
facility: Pines Care Research Center, LLC
state: Florida
city: Pembroke Pines
country: United States
facility: IDEAL Clinical Research
state: Florida
city: Columbus
country: United States
facility: Centricity Research Columbus Multispecialty
state: Georgia
city: Decatur
country: United States
facility: Accel Research Site - Neurostudies
state: Georgia
city: Lilburn
country: United States
facility: Lifeline Primary Care/CCT Research
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research, LLC
state: Georgia
city: Blackfoot
country: United States
facility: Bingham Memorial Hospital
state: Idaho
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Idaho Falls
country: United States
facility: Snake River Research, PLLC
state: Idaho
city: Chicago
country: United States
facility: Great Lakes Clinical Trials at Ravenswood Rheumatology
state: Illinois
city: Oak Lawn
country: United States
facility: Accelacare- DuPage Medical Group
state: Illinois
city: Evansville
country: United States
facility: AES Evansville
state: Indiana
city: Ames
country: United States
facility: Accellacare and McFarland Clinic
state: Iowa
city: Sioux City
country: United States
facility: Meridian Clinical Research
state: Iowa
city: Metairie
country: United States
facility: Med Pharmics, LLC
state: Louisiana
city: Elkridge
country: United States
facility: Centennial Medical Group
state: Maryland
city: Rockville
country: United States
facility: Meridian Clinical Research
state: Maryland
city: Methuen
country: United States
facility: ActivMed Practices and Research, LLC
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health Hospital
state: Michigan
city: Saint Louis
country: United States
facility: Edward A. Doisy Research Center-Saint Louis University Center for Vaccine Development
state: Missouri
city: Saint Louis
country: United States
facility: The Clinical Research Center, LLC
state: Missouri
city: Grand Island
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Norfolk
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Omaha
country: United States
facility: University Of Nebraska Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research Inc
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research Associates, LLC
state: Nebraska
city: Omaha
country: United States
facility: Midwest Regional Health Services, LLC/CCT Research
state: Nebraska
city: Henderson
country: United States
facility: Synexus Clinical Research US, Inc.
state: Nevada
city: Las Vegas
country: United States
facility: Excel Clinical Research
state: Nevada
city: Las Vegas
country: United States
facility: Santa Rosa Medical Centers of Nevada/ CCT Research
state: Nevada
city: Raritan
country: United States
facility: Amici Clinical Research
state: New Jersey
city: Albuquerque
country: United States
facility: MedPharmics, LLC
state: New Mexico
city: Cortland
country: United States
facility: Certified Research Associates
state: New York
city: Endwell
country: United States
facility: Meridian Clinical Research LLC
state: New York
city: New York
country: United States
facility: CHEAR Center LLC
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research Inc.
state: New York
city: Cary
country: United States
facility: Accellacare - Raleigh Medical Group
state: North Carolina
city: Charlotte
country: United States
facility: Accellacare Research of Charlotte
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Raleigh
country: United States
facility: Accellacare - Raleigh Medical Group
state: North Carolina
city: Rocky Mount
country: United States
facility: Accellacare, Inc. - Rocky Mount
state: North Carolina
city: Statesville
country: United States
facility: Accellacare - Piedmont
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare of Wilmington
state: North Carolina
city: Winston-Salem
country: United States
facility: Progressive Medicine of the Triad, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research
state: Ohio
city: Moore
country: United States
facility: Tekton Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute East
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Yukon
country: United States
facility: Tekton Research Inc.
state: Oklahoma
city: Camp Hill
country: United States
facility: Capital Area Research, LLC
state: Pennsylvania
city: Philadelphia
country: United States
facility: DM Clinical Research
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clinical Research- Providence
state: Rhode Island
city: Anderson
country: United States
facility: Synexus Clinical Research US, Inc.
state: South Carolina
city: Anderson
country: United States
facility: Velocity Clinical Research Anderson
state: South Carolina
city: Little River
country: United States
facility: Main Street Physician's Care-Waterway
state: South Carolina
city: Knoxville
country: United States
facility: Accellacare of Knoxville
state: Tennessee
city: Austin
country: United States
facility: Tekton Research, Inc.
state: Texas
city: Edinburg
country: United States
facility: Invesclinic US LLC
state: Texas
city: Houston
country: United States
facility: DM Clinical Research
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research
state: Texas
city: Plano
country: United States
facility: Research Your Health
state: Texas
city: Round Rock
country: United States
facility: Be Well Clinical Studies
state: Texas
city: Sugar Land
country: United States
facility: Mt Olympus Medical Research LLC
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Holladay
country: United States
facility: Olympus Family Medicine/CCT Research
state: Utah
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
city: Ogden
country: United States
facility: South Ogden Family Medicine/ CCT Research
state: Utah
city: West Jordan
country: United States
facility: Velocity Clinical Research, Salt Lake City
state: Utah
city: Annandale
country: United States
facility: Clinical Alliance for Research and Education Infectious Disease
state: Virginia
city: Portsmouth
country: United States
facility: Meridian Clinical Research, LLC
state: Virginia
city: Suffolk
country: United States
facility: Centricity Research Suffolk Primary Care
state: Virginia
city: Port Orchard
country: United States
facility: Sound Medical Research
state: Washington
city: Spokane
country: United States
facility: MultiCare Health System-DMOB (Deaconess Medical Office Building)
state: Washington
city: Berlin
country: Germany
facility: Klinische Forschung Berlin GbR
city: Berlin
country: Germany
facility: Studienzentrum Diabetespraxis Dr. Braun
city: Cottbus
country: Germany
facility: MECS Cottbus GmbH
city: Dresden
country: Germany
facility: Klinsche Forschung Dresden GmbH
city: Frankfurt
country: Germany
facility: IKF Institut fuer klinische Forschung Frankfurt
city: Hannover
country: Germany
facility: Klinische Forschung Hannover-Mitte GmbH
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover (MHH)
city: Hanover
country: Germany
facility: Siteworks GmbH
city: Heidelberg
country: Germany
facility: Siteworks Zentrum für Klinische Studien Heidelberg
city: Leipzig
country: Germany
facility: SIBAmed Studienzentrum GmbH & Co. KG
city: Mainz
country: Germany
facility: Dermatologische Gemeinschaftspraxis Dres. Quist
city: Oldenburg
country: Germany
facility: RED Institut GmbH
city: Rendsburg
country: Germany
facility: Siteworks Prufzentrum Rendsburg - HNO Research GmbH
city: Schwerin
country: Germany
facility: Klinische Forschung Schwerin GmbH
city: Wiesbaden
country: Germany
facility: Intermed GmbH, Institut fuer medizinische Forschung und Arzneimittelsicherheit
Study officials:
affiliation: Bavarian Nordic
name: Bernard Hoet, MD
role: STUDY_DIRECTOR
References: