MVA-BN-RSV Vaccine Trial

NCT05238025
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Terminated
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Participants
20,419
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Lead sponsor
Bavarian Nordic
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Start date
2022-04-19
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Number of sites
120
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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
clinicaltrials.gov
Short title
MVA-BN-RSV Vaccine Trial
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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
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Registry reports results
Yes
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Listing at source
Listed
clinicaltrials.gov
Recruitment status
Terminated
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Phase
Phase 3
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Study type
Interventional
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Reason stopped
The trial was terminated after the first RSV season because of the failure to meet the primary outcome measures of vaccine efficacy
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Completion date
2023-09-01
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First posted
2022-02-14
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Registry last updated
2024-10-31
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Primary completion date
2023-06-29
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Start date
2022-04-19
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Actual participants
20,419
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Participants
20,419
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Participant count basis
Actual
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Protocol amendments
6
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Number of sites
120
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Bavarian Nordic
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05238025
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ClinicalTrials.gov ID
NCT05238025
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

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

    Timeframe: 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)

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

    Timeframe: 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)

  1. Occurrence of PCR Confirmed RSV-associated ARD

    Timeframe: 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)

  2. Occurrence of Complications Related to PCR-confirmed RSV Disease

    Timeframe: 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.

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

    Timeframe: 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.

  4. Occurrence of Severe PCR Confirmed RSV-associated LRTD

    Timeframe: 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

  5. Number of Participants With Serious Adverse Events

    Timeframe: 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.

  6. Number of Participants With Grade 3 or Higher Adverse Events

    Timeframe: 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

  7. Number of Participants With Solicited Local Adverse Events

    Timeframe: 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.

  8. Number of Participants With Solicited Systemic Adverse Events

    Timeframe: 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.

  9. Number of Participants With Unsolicited Adverse Events

    Timeframe: Within 29 days after vaccination

    Number and percentage of study participants reporting any unsolicited adverse events within 29 days after vaccination.

  10. RSV-specific T-cell Responses

    Timeframe: 1 week after vaccination

    RSV-specific T-cell responses measured 1 week post vaccination in a subset of the study population

  11. RSV-specific Serum IgG Antibody Titers

    Timeframe: 2 weeks after vaccination

    Geometric Mean Titers (GMTs) based on RSV-specific Immunoglobulin G (IgG) Enzyme-linked Immunosorbent Assay (ELISA)

  12. RSV-specific Serum Neutralizing Antibody Titers (Subtype A)

    Timeframe: 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

  13. RSV-specific Serum Neutralizing Antibody Titers (Subtype B)

    Timeframe: 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

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
60 Years
Healthy volunteers
Yes

  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.

  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.

Sources for eligibility
clinicaltrials.gov

  • North Alabama Research Center, LLCAthens, United States
  • Central Alabama ResearchBirmingham, United States
  • Achieve Clinical Research, LLC d/b/a Accel Research SitesBirmingham, United States
  • Medical Affiliation Research CenterHuntsville, United States
  • Lenzmeier Family Medicine / CCT ResearchGlendale, United States
  • Aventiv Research Inc.Mesa, United States
  • Phoenix Clinical LLCPhoenix, United States
  • Pain Center of ArizonaPhoenix, United States
  • Cognitive Clinical Trials, LLCPhoenix, United States
  • Fiel Family and Sports Medicine/CCT ResearchTempe, United States
  • HOPE Research InstituteTempe, United States
  • Tucson Neuroscience Research, LLCTucson, United States
  • Lynn Institute of the OzarksLittle Rock, United States
  • Hope Clinical Research, LLCCanoga Park, United States
  • Marvel Clinical Research 002, LLCHuntington Beach, United States
  • Join Clinical TrialsHuntington Park, United States
  • Paradigm Clinical Research CenterLa Mesa, United States
  • Atella Clinical Research LLCLa Palma, United States
  • Chemidox Clinical Trials Inc.Lancaster, United States
  • ARK Clinical ResearchLong Beach, United States
  • Matrix Clinical ResearchLos Angeles, United States
  • Artemis Institute for Clinical ResearchSan Diego, United States
  • California Research FoundationSan Diego, United States
  • Diablo Clinical Research, Inc.Walnut Creek, United States
  • Lynn Institute of DenverAurora, United States

And 95 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)