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MVA-BN-RSV Vaccine Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05238025
Recruitment Status : Active, not recruiting
First Posted : February 14, 2022
Last Update Posted : January 18, 2023
Sponsor:
Information provided by (Responsible Party):
Bavarian Nordic

Study Description
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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

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Biological: MVA-BN-RSV vaccine Biological: Tris Buffered Saline (TBS) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : April 19, 2022
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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)
 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.
Experimental: Group 2: Single dose Placebo
Single dose of TBS (intramuscular injection; 0.5mL)
 Biological: Tris Buffered Saline (TBS)
One injection, solution for injection, intramuscular use, 0.5mL TBS, pH 7.7.


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of LRTD [ Time Frame: Over one RSV season (at least 6 months, and up to 12 months post vaccination) ]
    Occurrence of LRTD associated with RSV until the end of one RSV season (at least 6 months, and up to 12 months post vaccination).


Secondary Outcome Measures :
  1. Occurrence of ARD [ Time Frame: Over one RSV season (at least 6 months, and up to 12 months post vaccination) ]
    Occurrence of ARD associated with RSV until the end of one RSV season (at least 6 months, and up to 12 months post vaccination).

  2. Occurrence of complications and hospitalizations [ Time Frame: Over one RSV season (at least 6 months, and up to 12 months post vaccination) ]
    Occurrence of complications and hospitalizations related to PCR-confirmed RSV disease.

  3. Occurrence of any serious adverse events [ Time Frame: Up to 24 months after vaccination ]
    Occurrence of any serious adverse events at any time during the trial period.

  4. Occurrence of any grade 3 or higher adverse events [ Time Frame: Within 29 days after vaccination ]
    Occurrence of any grade 3 or higher adverse events assessed as related to study vaccine within 29 days after vaccination.

  5. Occurrence of solicited local adverse events [ Time Frame: Within 8 days after vaccination ]
    Occurrence of solicited local adverse events (pain, swelling, pruritus, erythema, induration) within 8 days after vaccination.

  6. Occurrence of solicited systemic adverse events [ Time Frame: Within 8 days after vaccination ]
    Occurrence of solicited systemic adverse events (body temperature, headache, fatigue, myalgia, nausea, chills) within 8 days after vaccination.

  7. Occurrence of any unsolicited adverse events [ Time Frame: Within 29 days after vaccination ]
    Occurrence of any unsolicited adverse events within 29 days after vaccination.

  8. RSV-specific T-cell responses [ Time Frame: Within 1 week after vaccination ]
    RSV-specific T-cell responses measured 1 week post vaccination in a subset of the study population

  9. RSV-specific serum IgG antibody titers [ Time Frame: 2 weeks after vaccination ]
    RSV-specific serum IgG antibody titers 2 weeks post vaccination in a subset of the study population

  10. RSV-specific serum neutralizing antibody titers [ Time Frame: Within 2 weeks after vaccination ]
    RSV-specific serum neutralizing antibody titers 2 weeks post vaccination (subtype A and B)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05238025


Locations
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Sponsors and Collaborators
Bavarian Nordic
Investigators
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Study Director: Bernard Hoet, MD Bavarian Nordic GmbH
More Information
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Responsible Party: Bavarian Nordic
ClinicalTrials.gov Identifier: NCT05238025    
Other Study ID Numbers: RSV-MVA-004
First Posted: February 14, 2022    Key Record Dates
Last Update Posted: January 18, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Syncytial Virus Infections
Virus Diseases
Infections
Pneumovirus Infections
Paramyxoviridae Infections
 Mononegavirales Infections
RNA Virus Infections
Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Antiviral Agents
Anti-Infective Agents