MVA-BN-RSV Vaccine Trial

Phase 3

Terminated

• Conditions: Respiratory Syncytial Virus Infections
• Interventions: Biological: MVA-BN-RSV vaccine; Biological: Tris Buffered Saline (TBS)

• Registration Number: NCT05238025
• Lead Sponsor: Bavarian Nordic

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-02-03
• Study First Posted: 2022-02-14
• Study Start: 2022-04-19
• Primary Completion: 2023-06-29
• Study Completion: 2023-09-01
• Results First Submitted: 2024-06-28
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-30
• Last Update Submitted: 2024-10-30
• Results First Posted: 2024-10-31
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20419

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Single dose MVA-BN-RSV	MVA-BN-RSV vaccine	Single dose (Week 0): MVA-BN-RSV virus with a titer of at least 3x10E8 Inf.U/0.5mL (intramuscular vaccination)
Group 2: Single dose Placebo	Tris Buffered Saline (TBS)	Single dose of TBS (intramuscular injection; 0.5mL)

Primary Outcome Measures

Name	Time	Method
Occurrence of PCR Confirmed RSV-associated LRTD With at Least 3 Symptoms	From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months	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)
Occurrence of PCR Confirmed RSV-associated LRTD With at Least 2 Symptoms	From 14 days post-vaccination up to the end of one RSV season, up to a maximum of 11 months	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)

Secondary Outcome Measures

Name	Time	Method
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	RSV-associated acute respiratory disease (ARD) is defined by the presence of either one ARD symptom lasting for at least 24 hours or two simultaneously occurring ARD symptoms (irrespective of duration), 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)
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	RSV-specific complications include the presence of acute clinical consequences of RSV infection, such as pneumonia (incl. bacterial superinfection), sepsis, positive blood culture, and pneumothorax as well as longer term consequences of RSV-specific symptoms, such as persistent worsening of chronic conditions (e.g. COPD), new onset of persistent medical conditions (e.g. chronically impaired lung function, asthma) or a worsening of the functional status of the patient, e.g. new onset of nursing or assisted living need. RSV disease had to be confirmed by PCR testing.
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	Hospitalization due to PCR confirmed RSV disease and/or any complication related to PCR-confirmed RSV disease. RSV-specific complications include the presence of acute clinical consequences of RSV infection, such as pneumonia (incl. bacterial superinfection), sepsis, positive blood culture, and pneumothorax as well as longer term consequences of RSV-specific symptoms, such as persistent worsening of chronic conditions (e.g. COPD), new onset of persistent medical conditions (e.g. chronically impaired lung function, asthma) or a worsening of the functional status of the patient, e.g. new onset of nursing or assisted living need. RSV disease had to be confirmed by PCR testing.
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	Severe RSV-associated LRTD is defined by the presence of clinical evidence of at least 1 sign or symptom of ARD and at least 1 of the following 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): 1) hypoxemia (oxygen saturation \<92% at rest in conjunction with an at least 3% decrease from baseline); 2) respiratory rate \>25 breaths/Min; 3) imaging evidence of new onset of bronchitis, bronchiolitis, or pneumonia
Number of Participants With Serious Adverse Events	From vaccination through study termination, up to 16 months	Number and percentage of study participants reporting any serious adverse events at any time during the trial period.
Number of Participants With Grade 3 or Higher Adverse Events	Within 29 days after vaccination	Number and percentage of study participants reporting any grade 3 or higher unsolicited adverse events assessed as related to study vaccine
Number of Participants With Solicited Local Adverse Events	Within 8 days after vaccination	Number and percentage of study participants reporting injection site reactions (solicited via electronic diaries) within 8 days after vaccination. The number of participants analyzed and the percentages are based on the subset of participants in the Safety Set that completed the electronic diary.
Number of Participants With Solicited Systemic Adverse Events	Within 8 days after vaccination	Number and percentage of study participants reporting systemic reactions (solicited via electronic diaries) within 8 days after vaccination. The number of participants analyzed and the percentages are based on the subset of participants in the Safety Set that completed the electronic diary.
Number of Participants With Unsolicited Adverse Events	Within 29 days after vaccination	Number and percentage of study participants reporting any unsolicited adverse events within 29 days after vaccination.
RSV-specific T-cell Responses	1 week after vaccination	RSV-specific T-cell responses measured 1 week post vaccination in a subset of the study population
RSV-specific Serum IgG Antibody Titers	2 weeks after vaccination	Geometric Mean Titers (GMTs) based on RSV-specific Immunoglobulin G (IgG) Enzyme-linked Immunosorbent Assay (ELISA)
RSV-specific Serum Neutralizing Antibody Titers (Subtype A)	2 weeks after vaccination	Geometric Mean Titers (GMTs) based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype A). Results below the lower limit of quantitation (LLOQ) are included with a value of 1/2 LLOQ
RSV-specific Serum Neutralizing Antibody Titers (Subtype B)	2 weeks after vaccination	Geometric Mean Titers (GMTs) based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype B). Results below the lower limit of quantitation (LLOQ) are included with a value of 1/2 LLOQ

Trial Locations

Locations (112)

Optimus U Corporation; 🇺🇸 Miami, Florida, United States

De La Cruz Research Center, LLC; 🇺🇸 Miami, Florida, United States

Great Lakes Clinical Trials at Ravenswood Rheumatology; 🇺🇸 Chicago, Illinois, United States

Artemis Institute for Clinical Research; 🇺🇸 San Diego, California, United States

CTI Clinical Research Center; 🇺🇸 Cincinnati, Ohio, United States

Velocity Clinical Research; 🇺🇸 Cincinnati, Ohio, United States

Henry Ford Health Hospital; 🇺🇸 Detroit, Michigan, United States

Lynn Health Science Institute East; 🇺🇸 Oklahoma City, Oklahoma, United States

Lynn Institute of the Ozarks; 🇺🇸 Little Rock, Arkansas, United States

Achieve Clinical Research, LLC d/b/a Accel Research Sites; 🇺🇸 Birmingham, Alabama, United States

Central Alabama Research; 🇺🇸 Birmingham, Alabama, United States

Lenzmeier Family Medicine / CCT Research; 🇺🇸 Glendale, Arizona, United States

North Alabama Research Center, LLC; 🇺🇸 Athens, Alabama, United States

Phoenix Clinical LLC; 🇺🇸 Phoenix, Arizona, United States

HOPE Research Institute; 🇺🇸 Tempe, Arizona, United States

Atella Clinical Research LLC; 🇺🇸 La Palma, California, United States

Fiel Family and Sports Medicine/CCT Research; 🇺🇸 Tempe, Arizona, United States

Join Clinical Trials; 🇺🇸 Huntington Park, California, United States

Hope Clinical Research, LLC; 🇺🇸 Canoga Park, California, United States

California Research Foundation; 🇺🇸 San Diego, California, United States

ARK Clinical Research; 🇺🇸 Long Beach, California, United States

Marvel Clinical Research 002, LLC; 🇺🇸 Huntington Beach, California, 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

Snake River Research, PLLC; 🇺🇸 Idaho Falls, Idaho, United States

K2 Medical Research, LLC; 🇺🇸 Maitland, Florida, United States

Matrix Clinical Research; 🇺🇸 Los Angeles, California, United States

Accelacare- DuPage Medical Group; 🇺🇸 Oak Lawn, Illinois, United States

Lifeline Primary Care/CCT Research; 🇺🇸 Lilburn, Georgia, United States

Diablo Clinical Research, Inc.; 🇺🇸 Walnut Creek, California, United States

Meridian Clinical Research; 🇺🇸 Rockville, Maryland, United States

Excel Clinical Research; 🇺🇸 Las Vegas, Nevada, United States

AES Evansville; 🇺🇸 Evansville, Indiana, United States

Med Pharmics, LLC; 🇺🇸 Metairie, Louisiana, United States

Pines Care Research Center, LLC; 🇺🇸 Pembroke Pines, Florida, United States

Meridian Clinical Research, LLC; 🇺🇸 Portsmouth, Virginia, United States

Accel Research Site - Neurostudies; 🇺🇸 Decatur, Georgia, United States

Midwest Regional Health Services, LLC/CCT Research; 🇺🇸 Omaha, Nebraska, United States

Centennial Medical Group; 🇺🇸 Elkridge, Maryland, United States

Clinical Research Prime; 🇺🇸 Idaho Falls, Idaho, United States

The Clinical Research Center, LLC; 🇺🇸 Saint Louis, Missouri, United States

Edward A. Doisy Research Center-Saint Louis University Center for Vaccine Development; 🇺🇸 Saint Louis, Missouri, United States

Accellacare - Raleigh Medical Group; 🇺🇸 Raleigh, North Carolina, United States

Accellacare - Piedmont; 🇺🇸 Statesville, North Carolina, United States

Amici Clinical Research; 🇺🇸 Raritan, New Jersey, United States

CHEAR Center LLC; 🇺🇸 New York, New York, United States

Accellacare Research of Charlotte; 🇺🇸 Charlotte, North Carolina, United States

Siteworks Prufzentrum Rendsburg - HNO Research GmbH; 🇩🇪 Rendsburg, Germany

Be Well Clinical Studies; 🇺🇸 Round Rock, Texas, United States

Studienzentrum Diabetespraxis Dr. Braun; 🇩🇪 Berlin, Germany

Velocity Clinical Research, Salt Lake City; 🇺🇸 West Jordan, Utah, United States

Research Your Health; 🇺🇸 Plano, Texas, United States

MultiCare Health System-DMOB (Deaconess Medical Office Building); 🇺🇸 Spokane, Washington, United States

Mt Olympus Medical Research LLC; 🇺🇸 Sugar Land, Texas, United States

Siteworks Zentrum für Klinische Studien Heidelberg; 🇩🇪 Heidelberg, Germany

Klinische Forschung Hannover-Mitte GmbH; 🇩🇪 Hannover, Germany

Intermed GmbH, Institut fuer medizinische Forschung und Arzneimittelsicherheit; 🇩🇪 Wiesbaden, Germany

Klinische Forschung Berlin GbR; 🇩🇪 Berlin, Germany

SIBAmed Studienzentrum GmbH & Co. KG; 🇩🇪 Leipzig, Germany

Medical Affiliation Research Center; 🇺🇸 Huntsville, Alabama, United States

ActivMed Practices and Research, LLC; 🇺🇸 Methuen, Massachusetts, United States

Pain Center of Arizona; 🇺🇸 Phoenix, Arizona, United States

Cognitive Clinical Trials, LLC; 🇺🇸 Phoenix, Arizona, United States

Tucson Neuroscience Research, LLC; 🇺🇸 Tucson, Arizona, United States

Accellacare, Inc. - Rocky Mount; 🇺🇸 Rocky Mount, North Carolina, United States

Lynn Institute of Denver; 🇺🇸 Aurora, Colorado, United States

Progressive Medicine of the Triad, LLC; 🇺🇸 Winston-Salem, North Carolina, United States

Velocity Clinical Research Anderson; 🇺🇸 Anderson, South Carolina, United States

Synexus Clinical Research US, Inc.; 🇺🇸 Anderson, South Carolina, United States

Aventiv Research Inc.; 🇺🇸 Mesa, Arizona, United States

Innovative Research Of West Florida, Inc.; 🇺🇸 Clearwater, Florida, United States

Doral Medical Research; 🇺🇸 Hialeah, Florida, United States

Global Health Research Center, Inc; 🇺🇸 Miami Lakes, Florida, United States

Paradigm Clinical Research Center; 🇺🇸 La Mesa, California, United States

IDEAL Clinical Research; 🇺🇸 Pembroke Pines, Florida, United States

Chemidox Clinical Trials Inc.; 🇺🇸 Lancaster, California, United States

Bingham Memorial Hospital; 🇺🇸 Blackfoot, Idaho, United States

Santa Rosa Medical Centers of Nevada/ CCT Research; 🇺🇸 Las Vegas, Nevada, United States

Rochester Clinical Research Inc.; 🇺🇸 Rochester, New York, United States

Meridian Clinical Research LLC; 🇺🇸 Endwell, New York, United States

PharmQuest; 🇺🇸 Greensboro, North Carolina, United States

Accellacare of Wilmington; 🇺🇸 Wilmington, North Carolina, United States

Tekton Research; 🇺🇸 Moore, Oklahoma, United States

Lynn Health Science Institute; 🇺🇸 Oklahoma City, Oklahoma, United States

Tekton Research Inc.; 🇺🇸 Yukon, Oklahoma, United States

Velocity Clinical Research- Providence; 🇺🇸 East Greenwich, Rhode Island, United States

DM Clinical Research; 🇺🇸 Tomball, Texas, United States

Capital Area Research, LLC; 🇺🇸 Camp Hill, Pennsylvania, United States

Accellacare of Knoxville; 🇺🇸 Knoxville, Tennessee, United States

Main Street Physician's Care-Waterway; 🇺🇸 Little River, South Carolina, United States

Invesclinic US LLC; 🇺🇸 Edinburg, Texas, United States

SMS Clinical Research; 🇺🇸 Mesquite, Texas, United States

Clinical Alliance for Research and Education Infectious Disease; 🇺🇸 Annandale, Virginia, United States

Olympus Family Medicine/CCT Research; 🇺🇸 Holladay, Utah, United States

South Ogden Family Medicine/ CCT Research; 🇺🇸 Ogden, Utah, United States

Sound Medical Research; 🇺🇸 Port Orchard, Washington, United States

Centricity Research Suffolk Primary Care; 🇺🇸 Suffolk, Virginia, United States

Tanner Clinic; 🇺🇸 Layton, Utah, United States

MECS Cottbus GmbH; 🇩🇪 Cottbus, Germany

IKF Institut fuer klinische Forschung Frankfurt; 🇩🇪 Frankfurt, Germany

Klinsche Forschung Dresden GmbH; 🇩🇪 Dresden, Germany

Medizinische Hochschule Hannover (MHH); 🇩🇪 Hannover, Germany

Siteworks GmbH; 🇩🇪 Hanover, Germany

RED Institut GmbH; 🇩🇪 Oldenburg, Germany

Dermatologische Gemeinschaftspraxis Dres. Quist; 🇩🇪 Mainz, Germany

Klinische Forschung Schwerin GmbH; 🇩🇪 Schwerin, Germany

MedPharmics, LLC; 🇺🇸 Albuquerque, New Mexico, United States

Tekton Research, Inc.; 🇺🇸 Austin, Texas, United States

Centricity Research Columbus Multispecialty; 🇺🇸 Columbus, Georgia, United States

Accellacare and McFarland Clinic; 🇺🇸 Ames, Iowa, United States

Certified Research Associates; 🇺🇸 Cortland, New York, United States