respiratory syncytial virus disease MedDRA version: 21.1 Level: LLT Classification code 10066742 Term: Respiratory syncytial virus infection prophylaxis System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Code: MVA-BN-RSV
Pharmaceutical Form: Suspension for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intramuscular use
Sponsors
Bavarian Nordic A/S
Eligibility
Sex/Gender
All
Inclusion 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 diseases (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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 21600
Exclusion criteria
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 immune-modifying 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 4 weeks after the trial vaccine administration. 14. Involvement with this trial as research personnel. 15. Planned leave or holiday of 4 consecutive weeks or more during the RSV season covered by the study, that would prohibit the reporting of ARI cases and attendance at symptom visits. 16. Pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the clinical efficacy of MVA-BN-RSV vaccine against lower respiratory tract disease (LRTD) associated with RSV. The estimand corresponding to the primary objective to assess vaccine efficacy is defined as 1 minus the hazard ratio of LRTD associated with RSV infection in the 2 vaccination groups in the population who are randomized and receive the study vaccination, regardless of early termination during the RSV season.;Secondary Objective: To assess the clinical efficacy of MVA-BN-RSV vaccine against acute respiratory disease (ARD) associated with RSV. The estimand corresponding to this secondary objective of assessing vaccine efficacy is defined as 1 minus the hazard ratio of ARD associated with RSV disease in the 2 vaccination groups in the population who are randomized and receive the study vaccination, regardless of early termination during the RSV season. To assess clinical efficacy of MVA-BN-RSV vaccine against complications or hospitalization related to confirmed RSV disease. To assess safety and reactogenicity of the MVA-BN-RSV vaccine in medically stable subjects =60 years of age. To assess the RSV-specific humoral and cellular immunity elicited by MVA-BN-RSV in a subset of the study population.;Primary end point(s): Occurrence of LRTD (=3 symptoms) associated with RSV until the end of one RSV season (up to 12 months after vaccination). RSV-associated LRTD is defined by the presence of clinical evidence of at least 3 sign or symptom of ARD (see below) 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) (nasopharyngeal (NP) swab to be collected within 5 days of symptom onset; preferably within 72 hours of symptom onset). •hypoxemia (oxygen saturation 25 breaths/Min •imaging evidence of new ons | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy (Key secondary) Occurrence of ARD associated with RSV until the end of one RSV season (up to 12 months after vaccination). RSV-associated ARD is defined by the presence of either one (1) ARD symptom lasting for at least 24 hours or two (2) 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). RSV disease must be laboratory confirmed by PCR (NP swab to be collected within 5 days of symptom onset; preferably within 72 hours of symptom onset). Occurrence of complications related to PCR-confirmed RSV disease. Occurrence of hospitalization due to confirmed RSV disease or due to any complication related to RSV-confirmed respiratory disease. Occurrence of LRTD (severe LRTD) associated with RSV until the end of one RSV season (up to 12 months after vaccination). RSV-associated LRTD is defined by the presence of clinical evidence of at least 1 sign or symptom of ARD (see above) 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) (nasopharyngeal (NP) swab to be collected within 5 days of symptom onset; preferably within 72 hours of symptom onset). • hypoxemia (oxygen saturation 25 breaths/Min • imaging evidence of new onset of bronchitis, bronchiolitis, or pneumonia Safety Occurrence of any serious adverse events at any time during the trial period. Occurrence of any grade 3 or higher adverse events assessed as related to study vaccine within 29 days after vaccination. Occurrence of solicited local adverse events (pain, swelling, pruritus, erythema, induration) within 8 days after vaccination. Occurrence of solicited systemic adverse events (body temperature, headache, fatigue, myalgia, na | — |
Countries
Germany, United Kingdom, United States
Contacts
Public Contactclinical-mailbox
Bavarian Nordic GmbH
Outcome results
None listed