Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
20419 participants
INTERVENTIONAL
2022-04-19
2023-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Group 1: Single dose MVA-BN-RSV
Single dose (Week 0): MVA-BN-RSV virus with a titer of at least 3x10E8 Inf.U/0.5mL (intramuscular vaccination)
MVA-BN-RSV vaccine
One injection, suspension for injection, intramuscular use, 0.5mL MVA-BN-RSV virus with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL in a Tris buffer at pH 7.7.
Group 2: Single dose Placebo
Single dose of TBS (intramuscular injection; 0.5mL)
Tris Buffered Saline (TBS)
One injection, solution for injection, intramuscular use, 0.5mL TBS, pH 7.7.
Interventions
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MVA-BN-RSV vaccine
One injection, suspension for injection, intramuscular use, 0.5mL MVA-BN-RSV virus with a titer of at least 3 x 10E8 infectious units (Inf.U)/0.5mL in a Tris buffer at pH 7.7.
Tris Buffered Saline (TBS)
One injection, solution for injection, intramuscular use, 0.5mL TBS, pH 7.7.
Eligibility Criteria
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Inclusion Criteria
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
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.
60 Years
ALL
Yes
Sponsors
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Bavarian Nordic
INDUSTRY
Responsible Party
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Principal Investigators
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Bernard Hoet, MD
Role: STUDY_DIRECTOR
Bavarian Nordic
Locations
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North Alabama Research Center, LLC
Athens, Alabama, United States
Central Alabama Research
Birmingham, Alabama, United States
Achieve Clinical Research, LLC d/b/a Accel Research Sites
Birmingham, Alabama, United States
Medical Affiliation Research Center
Huntsville, Alabama, United States
Lenzmeier Family Medicine / CCT Research
Glendale, Arizona, United States
Aventiv Research Inc.
Mesa, Arizona, United States
Phoenix Clinical LLC
Phoenix, Arizona, United States
Pain Center of Arizona
Phoenix, Arizona, United States
Cognitive Clinical Trials, LLC
Phoenix, Arizona, United States
Fiel Family and Sports Medicine/CCT Research
Tempe, Arizona, United States
HOPE Research Institute
Tempe, Arizona, United States
Tucson Neuroscience Research, LLC
Tucson, Arizona, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States
Hope Clinical Research, LLC
Canoga Park, California, United States
Marvel Clinical Research 002, LLC
Huntington Beach, California, United States
Join Clinical Trials
Huntington Park, California, United States
Paradigm Clinical Research Center
La Mesa, California, United States
Atella Clinical Research LLC
La Palma, California, United States
Chemidox Clinical Trials Inc.
Lancaster, California, United States
ARK Clinical Research
Long Beach, California, United States
Matrix Clinical Research
Los Angeles, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
California Research Foundation
San Diego, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Lynn Institute of Denver
Aurora, Colorado, United States
Innovative Research Of West Florida, Inc.
Clearwater, Florida, United States
Doral Medical Research
Hialeah, Florida, United States
K2 Medical Research, LLC
Maitland, Florida, United States
Optimus U Corporation
Miami, Florida, United States
De La Cruz Research Center, LLC
Miami, Florida, United States
Global Health Research Center, Inc
Miami Lakes, Florida, United States
Pines Care Research Center, LLC
Pembroke Pines, Florida, United States
IDEAL Clinical Research
Pembroke Pines, Florida, United States
Centricity Research Columbus Multispecialty
Columbus, Georgia, United States
Accel Research Site - Neurostudies
Decatur, Georgia, United States
Lifeline Primary Care/CCT Research
Lilburn, Georgia, United States
Meridian Clinical Research, LLC
Savannah, Georgia, United States
Bingham Memorial Hospital
Blackfoot, Idaho, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Snake River Research, PLLC
Idaho Falls, Idaho, United States
Great Lakes Clinical Trials at Ravenswood Rheumatology
Chicago, Illinois, United States
Accelacare- DuPage Medical Group
Oak Lawn, Illinois, United States
AES Evansville
Evansville, Indiana, United States
Accellacare and McFarland Clinic
Ames, Iowa, United States
Meridian Clinical Research
Sioux City, Iowa, United States
Med Pharmics, LLC
Metairie, Louisiana, United States
Centennial Medical Group
Elkridge, Maryland, United States
Meridian Clinical Research
Rockville, Maryland, United States
ActivMed Practices and Research, LLC
Methuen, Massachusetts, United States
Henry Ford Health Hospital
Detroit, Michigan, United States
Edward A. Doisy Research Center-Saint Louis University Center for Vaccine Development
St Louis, Missouri, United States
The Clinical Research Center, LLC
St Louis, Missouri, United States
Meridian Clinical Research, LLC
Grand Island, Nebraska, United States
Meridian Clinical Research, LLC
Norfolk, Nebraska, United States
University Of Nebraska Medical Center
Omaha, Nebraska, United States
Quality Clinical Research Inc
Omaha, Nebraska, United States
Meridian Clinical Research Associates, LLC
Omaha, Nebraska, United States
Midwest Regional Health Services, LLC/CCT Research
Omaha, Nebraska, United States
Synexus Clinical Research US, Inc.
Henderson, Nevada, United States
Excel Clinical Research
Las Vegas, Nevada, United States
Santa Rosa Medical Centers of Nevada/ CCT Research
Las Vegas, Nevada, United States
Amici Clinical Research
Raritan, New Jersey, United States
MedPharmics, LLC
Albuquerque, New Mexico, United States
Certified Research Associates
Cortland, New York, United States
Meridian Clinical Research LLC
Endwell, New York, United States
CHEAR Center LLC
New York, New York, United States
Rochester Clinical Research Inc.
Rochester, New York, United States
Accellacare - Raleigh Medical Group
Cary, North Carolina, United States
Accellacare Research of Charlotte
Charlotte, North Carolina, United States
PharmQuest
Greensboro, North Carolina, United States
Accellacare - Raleigh Medical Group
Raleigh, North Carolina, United States
Accellacare, Inc. - Rocky Mount
Rocky Mount, North Carolina, United States
Accellacare - Piedmont
Statesville, North Carolina, United States
Accellacare of Wilmington
Wilmington, North Carolina, United States
Progressive Medicine of the Triad, LLC
Winston-Salem, North Carolina, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Velocity Clinical Research
Cincinnati, Ohio, United States
Tekton Research
Moore, Oklahoma, United States
Lynn Health Science Institute East
Oklahoma City, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Tekton Research Inc.
Yukon, Oklahoma, United States
Capital Area Research, LLC
Camp Hill, Pennsylvania, United States
DM Clinical Research
Philadelphia, Pennsylvania, United States
Velocity Clinical Research- Providence
East Greenwich, Rhode Island, United States
Synexus Clinical Research US, Inc.
Anderson, South Carolina, United States
Velocity Clinical Research Anderson
Anderson, South Carolina, United States
Main Street Physician's Care-Waterway
Little River, South Carolina, United States
Accellacare of Knoxville
Knoxville, Tennessee, United States
Tekton Research, Inc.
Austin, Texas, United States
Invesclinic US LLC
Edinburg, Texas, United States
DM Clinical Research
Houston, Texas, United States
SMS Clinical Research
Mesquite, Texas, United States
Research Your Health
Plano, Texas, United States
Be Well Clinical Studies
Round Rock, Texas, United States
Mt Olympus Medical Research LLC
Sugar Land, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Olympus Family Medicine/CCT Research
Holladay, Utah, United States
Tanner Clinic
Layton, Utah, United States
South Ogden Family Medicine/ CCT Research
Ogden, Utah, United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, United States
Clinical Alliance for Research and Education Infectious Disease
Annandale, Virginia, United States
Meridian Clinical Research, LLC
Portsmouth, Virginia, United States
Centricity Research Suffolk Primary Care
Suffolk, Virginia, United States
Sound Medical Research
Port Orchard, Washington, United States
MultiCare Health System-DMOB (Deaconess Medical Office Building)
Spokane, Washington, United States
Klinische Forschung Berlin GbR
Berlin, , Germany
Studienzentrum Diabetespraxis Dr. Braun
Berlin, , Germany
MECS Cottbus GmbH
Cottbus, , Germany
Klinsche Forschung Dresden GmbH
Dresden, , Germany
IKF Institut fuer klinische Forschung Frankfurt
Frankfurt, , Germany
Klinische Forschung Hannover-Mitte GmbH
Hanover, , Germany
Siteworks GmbH
Hanover, , Germany
Medizinische Hochschule Hannover (MHH)
Hanover, , Germany
Siteworks Zentrum für Klinische Studien Heidelberg
Heidelberg, , Germany
SIBAmed Studienzentrum GmbH & Co. KG
Leipzig, , Germany
Dermatologische Gemeinschaftspraxis Dres. Quist
Mainz, , Germany
RED Institut GmbH
Oldenburg, , Germany
Siteworks Prufzentrum Rendsburg - HNO Research GmbH
Rendsburg, , Germany
Klinische Forschung Schwerin GmbH
Schwerin, , Germany
Intermed GmbH, Institut fuer medizinische Forschung und Arzneimittelsicherheit
Wiesbaden, , Germany
Countries
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References
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Jordan E, Jenkins V, Silbernagl G, Chavez MPV, Schmidt D, Schnorfeil F, Schultz S, Chen L, Salgado F, Jacquet JM, Welte T, De Moerlooze L. A multivalent RSV vaccine based on the modified vaccinia Ankara vector shows moderate protection against disease caused by RSV in older adults in a phase 3 clinical study. Vaccine. 2024 Dec 2;42(26):126427. doi: 10.1016/j.vaccine.2024.126427. Epub 2024 Oct 25.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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RSV-MVA-004
Identifier Type: -
Identifier Source: org_study_id
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