MVA-BN-RSV Vaccine Trial

NCT05238025 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: RSV-MVA-004
• Study Type: interventional
• Target: 20,419
• Locations: 2 countries
• Sites: 120

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

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (2)

• Occurrence of PCR Confirmed RSV-associated LRTD With at Least 3 Symptoms

  RSV-associated lower respiratory tract disease (LRTD) is defined by the presence of clinical evidence of at least 1 sign or symptom of acute respiratory disease (ARD) and at least 3 LRTD signs or symptoms with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR)

  From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months

• Occurrence of PCR Confirmed RSV-associated LRTD With at Least 2 Symptoms

  RSV-associated lower respiratory tract disease (LRTD) is defined by the presence of clinical evidence of at least 1 sign or symptom of acute respiratory disease (ARD) and at least 2 LRTD signs or symptoms with onset ≥14 days following vaccination until the end of one RSV season (up to 12 months after vaccination), confirmed and documented by a medical professional, together with RSV disease confirmed by polymerase chain reaction (PCR)

  From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months

Secondary Outcomes (13)

• Occurrence of PCR Confirmed RSV-associated ARD

  From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months

• Occurrence of Complications Related to PCR-confirmed RSV Disease

  From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months

• Occurrence of Hospitalization Due to Confirmed RSV Disease or Due to Any Complication Related to RSV-confirmed Respiratory Disease

  From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months

• Occurrence of Severe PCR Confirmed RSV-associated LRTD

  From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months

• Number of Participants With Serious Adverse Events

  From vaccination through study termination, up to 16 months

Study Arms (2)

Group 1: Single dose MVA-BN-RSV

EXPERIMENTAL

Single dose (Week 0): MVA-BN-RSV virus with a titer of at least 3x10E8 Inf.U/0.5mL (intramuscular vaccination)

Biological: MVA-BN-RSV vaccine

Group 2: Single dose Placebo

EXPERIMENTAL

Single dose of TBS (intramuscular injection; 0.5mL)

Biological: Tris Buffered Saline (TBS)

Interventions

MVA-BN-RSV vaccine BIOLOGICAL

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 1: Single dose MVA-BN-RSV

Tris Buffered Saline (TBS) BIOLOGICAL

One injection, solution for injection, intramuscular use, 0.5mL TBS, pH 7.7.

Group 2: Single dose Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects ≥60 years of age.
• Informed Consent signed by the subject.
• 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.
• Absence of known, current, and life-limiting diagnoses that render survival to completion of the protocol unlikely.
• Ability to comply with trial requirements, which necessitates access to transportation to on-site visits, including symptom visits for a nasopharyngeal swab.
• 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.
• 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.

You may not qualify if:

• 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.
• Known or suspected impairment of immunologic functions, including chronic inflammatory bowel disorders.
• Clinically significant mental disorder that would prevent patients from giving informed consent and complying with study procedures (e.g., completion of the electronic diary).
• Active or recent (within 6 months before enrollment) history of chronic alcohol abuse.
• History of a serious reaction to any prior vaccination or Guillain-Barré syndrome (GBS) within 6 weeks of any prior influenza immunization.
• 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
• 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.
• Previous vaccination with an RSV vaccine, or any planned vaccination with an RSV vaccine other than the trial vaccine.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Bavarian Nordic: lead

Study Sites (120)

North Alabama Research Center, LLC

Athens, Alabama, 35611, United States

Location

Central Alabama Research

Birmingham, Alabama, 35209, United States

Location

Achieve Clinical Research, LLC d/b/a Accel Research Sites

Birmingham, Alabama, 35216, United States

Location

Medical Affiliation Research Center

Huntsville, Alabama, 35801, United States

Location

Lenzmeier Family Medicine / CCT Research

Glendale, Arizona, 85308, United States

Location

Aventiv Research Inc.

Mesa, Arizona, 85210, United States

Location

Phoenix Clinical LLC

Phoenix, Arizona, 85014, United States

Location

Pain Center of Arizona

Phoenix, Arizona, 85018, United States

Location

Cognitive Clinical Trials, LLC

Phoenix, Arizona, 85044, United States

Location

Fiel Family and Sports Medicine/CCT Research

Tempe, Arizona, 85283, United States

Location

HOPE Research Institute

Tempe, Arizona, 85284, United States

Location

Tucson Neuroscience Research, LLC

Tucson, Arizona, 85710, United States

Location

Lynn Institute of the Ozarks

Little Rock, Arkansas, 72204, United States

Location

Hope Clinical Research, LLC

Canoga Park, California, 91303, United States

Location

Marvel Clinical Research 002, LLC

Huntington Beach, California, 92647, United States

Location

Join Clinical Trials

Huntington Park, California, 90255, United States

Location

Paradigm Clinical Research Center

La Mesa, California, 91942, United States

Location

Atella Clinical Research LLC

La Palma, California, 90623, United States

Location

Chemidox Clinical Trials Inc.

Lancaster, California, 93534, United States

Location

ARK Clinical Research

Long Beach, California, 90806, United States

Location

Matrix Clinical Research

Los Angeles, California, 90057, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

California Research Foundation

San Diego, California, 92123, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Lynn Institute of Denver

Aurora, Colorado, 80012, United States

Location

Innovative Research Of West Florida, Inc.

Clearwater, Florida, 33756, United States

Location

Doral Medical Research

Hialeah, Florida, 33016, United States

Location

K2 Medical Research, LLC

Maitland, Florida, 32751, United States

Location

Optimus U Corporation

Miami, Florida, 33125, United States

Location

De La Cruz Research Center, LLC

Miami, Florida, 33184, United States

Location

Global Health Research Center, Inc

Miami Lakes, Florida, 33016, United States

Location

Pines Care Research Center, LLC

Pembroke Pines, Florida, 33024, United States

Location

IDEAL Clinical Research

Pembroke Pines, Florida, 33026, United States

Location

Centricity Research Columbus Multispecialty

Columbus, Georgia, 31904, United States

Location

Accel Research Site - Neurostudies

Decatur, Georgia, 30030, United States

Location

Lifeline Primary Care/CCT Research

Lilburn, Georgia, 30047, United States

Location

Meridian Clinical Research, LLC

Savannah, Georgia, 31406, United States

Location

Bingham Memorial Hospital

Blackfoot, Idaho, 83221, United States

Location

Clinical Research Prime

Idaho Falls, Idaho, 83404, United States

Location

Snake River Research, PLLC

Idaho Falls, Idaho, 83404, United States

Location

Great Lakes Clinical Trials at Ravenswood Rheumatology

Chicago, Illinois, 60625, United States

Location

Accelacare- DuPage Medical Group

Oak Lawn, Illinois, 60453, United States

Location

AES Evansville

Evansville, Indiana, 47714, United States

Location

Accellacare and McFarland Clinic

Ames, Iowa, 50010, United States

Location

Meridian Clinical Research

Sioux City, Iowa, 51106, United States

Location

Med Pharmics, LLC

Metairie, Louisiana, 70006, United States

Location

Centennial Medical Group

Elkridge, Maryland, 21075, United States

Location

Meridian Clinical Research

Rockville, Maryland, 20854, United States

Location

ActivMed Practices and Research, LLC

Methuen, Massachusetts, 01844, United States

Location

Henry Ford Health Hospital

Detroit, Michigan, 48202, United States

Location

Edward A. Doisy Research Center-Saint Louis University Center for Vaccine Development

St Louis, Missouri, 63104, United States

Location

The Clinical Research Center, LLC

St Louis, Missouri, 63141, United States

Location

Meridian Clinical Research, LLC

Grand Island, Nebraska, 68803, United States

Location

Meridian Clinical Research, LLC

Norfolk, Nebraska, 68701, United States

Location

University Of Nebraska Medical Center

Omaha, Nebraska, 68105, United States

Location

Quality Clinical Research Inc

Omaha, Nebraska, 68114, United States

Location

Meridian Clinical Research Associates, LLC

Omaha, Nebraska, 68134, United States

Location

Midwest Regional Health Services, LLC/CCT Research

Omaha, Nebraska, 68144, United States

Location

Synexus Clinical Research US, Inc.

Henderson, Nevada, 89052, United States

Location

Excel Clinical Research

Las Vegas, Nevada, 89109, United States

Location

Santa Rosa Medical Centers of Nevada/ CCT Research

Las Vegas, Nevada, 89119, United States

Location

Amici Clinical Research

Raritan, New Jersey, 08869, United States

Location

MedPharmics, LLC

Albuquerque, New Mexico, 87102, United States

Location

Certified Research Associates

Cortland, New York, 13045, United States

Location

Meridian Clinical Research LLC

Endwell, New York, 13760, United States

Location

CHEAR Center LLC

New York, New York, 10455, United States

Location

Rochester Clinical Research Inc.

Rochester, New York, 14609, United States

Location

Accellacare - Raleigh Medical Group

Cary, North Carolina, 27518, United States

Location

Accellacare Research of Charlotte

Charlotte, North Carolina, 28209, United States

Location

PharmQuest

Greensboro, North Carolina, 27408, United States

Location

Accellacare - Raleigh Medical Group

Raleigh, North Carolina, 27609, United States

Location

Accellacare, Inc. - Rocky Mount

Rocky Mount, North Carolina, 27804, United States

Location

Accellacare - Piedmont

Statesville, North Carolina, 28625, United States

Location

Accellacare of Wilmington

Wilmington, North Carolina, 28401, United States

Location

Progressive Medicine of the Triad, LLC

Winston-Salem, North Carolina, 27103, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

Velocity Clinical Research

Cincinnati, Ohio, 45242, United States

Location

Tekton Research

Moore, Oklahoma, 73160, United States

Location

Lynn Health Science Institute East

Oklahoma City, Oklahoma, 73111, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Tekton Research Inc.

Yukon, Oklahoma, 73099, United States

Location

Capital Area Research, LLC

Camp Hill, Pennsylvania, 17011, United States

Location

DM Clinical Research

Philadelphia, Pennsylvania, 19107, United States

Location

Velocity Clinical Research- Providence

East Greenwich, Rhode Island, 02818, United States

Location

Synexus Clinical Research US, Inc.

Anderson, South Carolina, 29621, United States

Location

Velocity Clinical Research Anderson

Anderson, South Carolina, 29621, United States

Location

Main Street Physician's Care-Waterway

Little River, South Carolina, 29566, United States

Location

Accellacare of Knoxville

Knoxville, Tennessee, 37938, United States

Location

Tekton Research, Inc.

Austin, Texas, 78745, United States

Location

Invesclinic US LLC

Edinburg, Texas, 78539, United States

Location

DM Clinical Research

Houston, Texas, 77065, United States

Location

SMS Clinical Research

Mesquite, Texas, 75149, United States

Location

Research Your Health

Plano, Texas, 75093, United States

Location

Be Well Clinical Studies

Round Rock, Texas, 78681, United States

Location

Mt Olympus Medical Research LLC

Sugar Land, Texas, 77479, United States

Location

DM Clinical Research

Tomball, Texas, 77375, United States

Location

Olympus Family Medicine/CCT Research

Holladay, Utah, 84117, United States

Location

Tanner Clinic

Layton, Utah, 84041, United States

Location

South Ogden Family Medicine/ CCT Research

Ogden, Utah, 84405, United States

Location

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, 84088, United States

Location

Clinical Alliance for Research and Education Infectious Disease

Annandale, Virginia, 22003-7347, United States

Location

Meridian Clinical Research, LLC

Portsmouth, Virginia, 23703, United States

Location

Centricity Research Suffolk Primary Care

Suffolk, Virginia, 23435, United States

Location

Sound Medical Research

Port Orchard, Washington, 98366, United States

Location

MultiCare Health System-DMOB (Deaconess Medical Office Building)

Spokane, Washington, 99204, United States

Location

Klinische Forschung Berlin GbR

Berlin, 10787, Germany

Location

Studienzentrum Diabetespraxis Dr. Braun

Berlin, 13187, Germany

Location

MECS Cottbus GmbH

Cottbus, 03050, Germany

Location

Klinsche Forschung Dresden GmbH

Dresden, 01069, Germany

Location

IKF Institut fuer klinische Forschung Frankfurt

Frankfurt, 60596, Germany

Location

Klinische Forschung Hannover-Mitte GmbH

Hanover, 30159, Germany

Location

Siteworks GmbH

Hanover, 30449, Germany

Location

Medizinische Hochschule Hannover (MHH)

Hanover, 30625, Germany

Location

Siteworks Zentrum für Klinische Studien Heidelberg

Heidelberg, 69115, Germany

Location

SIBAmed Studienzentrum GmbH & Co. KG

Leipzig, 04103, Germany

Location

Dermatologische Gemeinschaftspraxis Dres. Quist

Mainz, 55128, Germany

Location

RED Institut GmbH

Oldenburg, 23758, Germany

Location

Siteworks Prufzentrum Rendsburg - HNO Research GmbH

Rendsburg, 24768, Germany

Location

Klinische Forschung Schwerin GmbH

Schwerin, 19055, Germany

Location

Intermed GmbH, Institut fuer medizinische Forschung und Arzneimittelsicherheit

Wiesbaden, 65189, Germany

Location

Related Publications (1)

• 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.

  PMID: 39461302 DERIVED

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Limitations and Caveats

Study terminated after the first RSV season, since the first primary endpoint was not met

Results Point of Contact

• Title: Program Lead, Clinical Operations
• Organization: Bavarian Nordic A/S

info@bavarian-nordic.com

+45 3326

Study Officials

• Bernard Hoet, MD

  Bavarian Nordic

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 14, 2022
• Study Start: April 19, 2022
• Primary Completion: June 29, 2023
• Study Completion: September 1, 2023
• Last Updated: October 31, 2024
• Results First Posted: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (105); DE (15)