MVA-BN-RSV Vaccine Trial

Respiratory Syncytial Virus Infections Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05238025
• Other study ID #: RSV-MVA-004
• Status: Completed
• Phase: Phase 3
• Start date: April 19, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: September 2023
• Source: Bavarian Nordic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21656
• Est. completion date: September 1, 2023
• Est. primary completion date: June 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
Germany	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	Hannover
Germany	Medizinische Hochschule Hannover (MHH)	Hannover
Germany	Siteworks GmbH	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
United States	MedPharmics, LLC	Albuquerque	New Mexico
United States	Accellacare and McFarland Clinic	Ames	Iowa
United States	Synexus Clinical Research US, Inc.	Anderson	South Carolina
United States	Velocity Clinical Research Anderson	Anderson	South Carolina
United States	Clinical Alliance for Research and Education Infectious Disease	Annandale	Virginia
United States	North Alabama Research Center, LLC	Athens	Alabama
United States	Lynn Institute of Denver	Aurora	Colorado
United States	Tekton Research, Inc.	Austin	Texas
United States	Achieve Clinical Research, LLC d/b/a Accel Research Sites	Birmingham	Alabama
United States	Central Alabama Research	Birmingham	Alabama
United States	Bingham Memorial Hospital	Blackfoot	Idaho
United States	Capital Area Research, LLC	Camp Hill	Pennsylvania
United States	Hope Clinical Research, LLC	Canoga Park	California
United States	Accellacare - Raleigh Medical Group	Cary	North Carolina
United States	Accellacare Research of Charlotte	Charlotte	North Carolina
United States	Great Lakes Clinical Trials at Ravenswood Rheumatology	Chicago	Illinois
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Velocity Clinical Research	Cincinnati	Ohio
United States	Innovative Research Of West Florida, Inc.	Clearwater	Florida
United States	Centricity Research Columbus Multispecialty	Columbus	Georgia
United States	Certified Research Associates	Cortland	New York
United States	Accel Research Site - Neurostudies	Decatur	Georgia
United States	Henry Ford Health Hospital	Detroit	Michigan
United States	Velocity Clinical Research- Providence	East Greenwich	Rhode Island
United States	Invesclinic US LLC	Edinburg	Texas
United States	Centennial Medical Group	Elkridge	Maryland
United States	Meridian Clinical Research LLC	Endwell	New York
United States	AES Evansville	Evansville	Indiana
United States	Lenzmeier Family Medicine / CCT Research	Glendale	Arizona
United States	Meridian Clinical Research, LLC	Grand Island	Nebraska
United States	PharmQuest	Greensboro	North Carolina
United States	Synexus Clinical Research US, Inc.	Henderson	Nevada
United States	Doral Medical Research	Hialeah	Florida
United States	Olympus Family Medicine/CCT Research	Holladay	Utah
United States	DM Clinical Research	Houston	Texas
United States	Marvel Clinical Research 002, LLC	Huntington Beach	California
United States	Join Clinical Trials	Huntington Park	California
United States	Medical Affiliation Research Center	Huntsville	Alabama
United States	Clinical Research Prime	Idaho Falls	Idaho
United States	Snake River Research, PLLC	Idaho Falls	Idaho
United States	Accellacare of Knoxville	Knoxville	Tennessee
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	Excel Clinical Research	Las Vegas	Nevada
United States	Santa Rosa Medical Centers of Nevada/ CCT Research	Las Vegas	Nevada
United States	Tanner Clinic	Layton	Utah
United States	Lifeline Primary Care/CCT Research	Lilburn	Georgia
United States	Main Street Physician's Care-Waterway	Little River	South Carolina
United States	Lynn Institute of the Ozarks	Little Rock	Arkansas
United States	ARK Clinical Research	Long Beach	California
United States	Matrix Clinical Research	Los Angeles	California
United States	K2 Medical Research, LLC	Maitland	Florida
United States	Aventiv Research Inc.	Mesa	Arizona
United States	SMS Clinical Research	Mesquite	Texas
United States	Med Pharmics, LLC	Metairie	Louisiana
United States	ActivMed Practices and Research, LLC	Methuen	Massachusetts
United States	De La Cruz Research Center, LLC	Miami	Florida
United States	Optimus U Corporation	Miami	Florida
United States	Global Health Research Center, Inc	Miami Lakes	Florida
United States	Tekton Research	Moore	Oklahoma
United States	CHEAR Center LLC	New York	New York
United States	Meridian Clinical Research, LLC	Norfolk	Nebraska
United States	Accelacare- DuPage Medical Group	Oak Lawn	Illinois
United States	South Ogden Family Medicine/ CCT Research	Ogden	Utah
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Lynn Health Science Institute East	Oklahoma City	Oklahoma
United States	Meridian Clinical Research Associates, LLC	Omaha	Nebraska
United States	Midwest Regional Health Services, LLC/CCT Research	Omaha	Nebraska
United States	Quality Clinical Research Inc	Omaha	Nebraska
United States	University Of Nebraska Medical Center	Omaha	Nebraska
United States	IDEAL Clinical Research	Pembroke Pines	Florida
United States	Pines Care Research Center, LLC	Pembroke Pines	Florida
United States	DM Clinical Research	Philadelphia	Pennsylvania
United States	Cognitive Clinical Trials, LLC	Phoenix	Arizona
United States	Pain Center of Arizona	Phoenix	Arizona
United States	Phoenix Clinical LLC	Phoenix	Arizona
United States	Research Your Health	Plano	Texas
United States	Sound Medical Research	Port Orchard	Washington
United States	Meridian Clinical Research, LLC	Portsmouth	Virginia
United States	Accellacare - Raleigh Medical Group	Raleigh	North Carolina
United States	Amici Clinical Research	Raritan	New Jersey
United States	Rochester Clinical Research Inc.	Rochester	New York
United States	Meridian Clinical Research	Rockville	Maryland
United States	Accellacare, Inc. - Rocky Mount	Rocky Mount	North Carolina
United States	Be Well Clinical Studies	Round Rock	Texas
United States	Edward A. Doisy Research Center-Saint Louis University Center for Vaccine Development	Saint Louis	Missouri
United States	The Clinical Research Center, LLC	Saint Louis	Missouri
United States	Artemis Institute for Clinical Research	San Diego	California
United States	California Research Foundation	San Diego	California
United States	Meridian Clinical Research, LLC	Savannah	Georgia
United States	Meridian Clinical Research	Sioux City	Iowa
United States	MultiCare Health System-DMOB (Deaconess Medical Office Building)	Spokane	Washington
United States	Accellacare - Piedmont	Statesville	North Carolina
United States	Centricity Research Suffolk Primary Care	Suffolk	Virginia
United States	Mt Olympus Medical Research LLC	Sugar Land	Texas
United States	Fiel Family and Sports Medicine/CCT Research	Tempe	Arizona
United States	HOPE Research Institute	Tempe	Arizona
United States	DM Clinical Research	Tomball	Texas
United States	Tucson Neuroscience Research, LLC	Tucson	Arizona
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Velocity Clinical Research, Salt Lake City	West Jordan	Utah
United States	Accellacare of Wilmington	Wilmington	North Carolina
United States	Progressive Medicine of the Triad, LLC	Winston-Salem	North Carolina
United States	Tekton Research Inc.	Yukon	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Bavarian Nordic

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of LRTD	Occurrence of LRTD associated with RSV until the end of one RSV season (at least 6 months, and up to 12 months post vaccination).	Over one RSV season (at least 6 months, and up to 12 months post vaccination)
Secondary	Occurrence of ARD	Occurrence of ARD associated with RSV until the end of one RSV season (at least 6 months, and up to 12 months post vaccination).	Over one RSV season (at least 6 months, and up to 12 months post vaccination)
Secondary	Occurrence of complications and hospitalizations	Occurrence of complications and hospitalizations related to PCR-confirmed RSV disease.	Over one RSV season (at least 6 months, and up to 12 months post vaccination)
Secondary	Occurrence of any serious adverse events	Occurrence of any serious adverse events at any time during the trial period.	Up to 24 months after vaccination
Secondary	Occurrence of any grade 3 or higher adverse events	Occurrence of any grade 3 or higher adverse events assessed as related to study vaccine within 29 days after vaccination.	Within 29 days after vaccination
Secondary	Occurrence of solicited local adverse events	Occurrence of solicited local adverse events (pain, swelling, pruritus, erythema, induration) within 8 days after vaccination.	Within 8 days after vaccination
Secondary	Occurrence of solicited systemic adverse events	Occurrence of solicited systemic adverse events (body temperature, headache, fatigue, myalgia, nausea, chills) within 8 days after vaccination.	Within 8 days after vaccination
Secondary	Occurrence of any unsolicited adverse events	Occurrence of any unsolicited adverse events within 29 days after vaccination.	Within 29 days after vaccination
Secondary	RSV-specific T-cell responses	RSV-specific T-cell responses measured 1 week post vaccination in a subset of the study population	Within 1 week after vaccination
Secondary	RSV-specific serum IgG antibody titers	RSV-specific serum IgG antibody titers 2 weeks post vaccination in a subset of the study population	2 weeks after vaccination
Secondary	RSV-specific serum neutralizing antibody titers	RSV-specific serum neutralizing antibody titers 2 weeks post vaccination (subtype A and B)	Within 2 weeks after vaccination