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RSV-MVA-BN Vaccine Phase II Trial in ≥ 55 Year Old Adults

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ClinicalTrials.gov Identifier: NCT02873286
Recruitment Status : Completed
First Posted : August 19, 2016
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Bavarian Nordic

Brief Summary:

A total of 400 subjects will be recruited into five treatment subject groups à 80 subjects.Subject will receive two administrations 4 weeks apart which will consist of MVA-BN-RSV Dose 1, MVA-BN-RSV Dose 2 or Placebo (TBS).

86 subjects from 2 treatment groups (43 per treatment group) are supposed to receive one (booster) dose of MVA-BN-RSV vaccine approximately one year after their first vaccination. In this booster substudy, eligible subjects will receive the same dose they received during the main trial.


Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Biological: MVA-BN-RSV Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: A Randomized, Single-blind, Placebo Controlled, Dose-ranging Phase II Trial in ≥ 55 Year Old Adults to Evaluate the Safety and Immunogenicity of the Recombinant MVA-BN-RSV Vaccine
Actual Study Start Date : September 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
First vaccination dose 1 MVA-BN-RSV, second vaccination placebo, third vaccination (sub-group) MVA-BN-RSV
Biological: MVA-BN-RSV
MVA-mBN294B

Other: Placebo
Tris Buffered Saline, sterile

Experimental: Group 2
First vaccination dose 1 MVA-BN-RSV, second vaccination dose 1 MVA-BN-RSV
Biological: MVA-BN-RSV
MVA-mBN294B

Experimental: Group 3
First vaccination dose 2 MVA-BN-RSV, second vaccination placebo, third vaccination (sub-group) MVA-BN-RSV
Biological: MVA-BN-RSV
MVA-mBN294B

Other: Placebo
Tris Buffered Saline, sterile

Experimental: Group 4
First vaccination dose 2 MVA-BN-RSV, second vaccination dose 2 MVA-BN-RSV
Biological: MVA-BN-RSV
MVA-mBN294B

Experimental: Group 5
First vaccination placebo, second vaccination placebo
Other: Placebo
Tris Buffered Saline, sterile




Primary Outcome Measures :
  1. Plaque Reduction Neutralization Test (PRNT) [ Time Frame: 2 weeks post last vaccination ]
    Geometric Mean Titers (GMTs) after one or two MVA-BN-RSV vaccinations or placebo measured by Plaque Reduction Neutralization Test (PRNT; against strain A) 2 weeks post last vaccination.


Secondary Outcome Measures :
  1. SAE [ Time Frame: Screening up to week 34 after first vaccination ]
    Occurrence, relationship to the trial vaccine and intensity of any serious adverse event (SAE).

  2. AE ≥ Grade 3 [ Time Frame: within 4 weeks after each vaccination ]
    Occurrence of any Grade 3 or higher adverse events (AE) possibly, probably or definitely related to the trial vaccine within 4 weeks after each vaccination.



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (Main study):

  1. Male and female subjects, ≥ 55 years of age.
  2. Prior to performance of any trial specific procedures, the subject has read, signed and dated an informed consent form, having been advised of the risks and benefits of the trial in a language understood by the subject, and has signed the Health Insurance Portability and Accountability Act (HIPAA) authorization form.
  3. Subjects without symptomatic cardiopulmonary and/or metabolic disease. Note that subjects who have any active symptoms related to cardiac and/or pulmonary and/or metabolic disease (including e.g. uncontrolled asthma, angina pectoris, hyperglycaemia or other episodic symptoms), or who receive ongoing therapy to control current, active symptoms, are not eligible. Subjects on stable treatment (no change in ≥ 1 month) for previous and controlled symptoms or conditions are eligible. The following are examples of subjects who may bear cardiopulmonary or metabolic diagnoses but who would remain eligible:

    • Subjects on stable (no change in ≥ 1 month) therapy for findings (e.g. hypertension, hyperlipidemia) which are not associated with current symptoms or disability.
    • Subjects with type II diabetes mellitus are considered eligible as long as they are stable on oral antidiabetics and have either a documented glycated hemoglobin (HbA1c) of ≤ 8 % within three months prior to trial participation or confirmation of controlled blood glucose level must be obtained at the SCR (screening) visit by a lab test.
    • Subjects who receive short term treatment for temporary conditions.
    • Other clinically insignificant findings not deemed to be associated with increased risk for respiratory viral infections as determined by the investigator.
  4. Able to comply with trial requirements; including access to transportation for trial visits.
  5. Body mass index (BMI) ≥ 18.5 and ≤ 39.9

    BMI formula for pounds and inches:

    BMI = (bodyweight in pounds) * 703 (bodyheight in inches)2

  6. Women of childbearing potential (WOCBP) must have used an acceptable method of contraception for at least 30 days prior to the first vaccination, must agree to use an acceptable method of contraception (as defined in Section 8.2.11) during the trial, and must avoid becoming pregnant for at least 28 days after the last vaccination. WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to each vaccination
  7. Not clinically significant laboratory values as defined in the protocol, excluding any Grade ≥ 3 toxicity.
  8. Negative human immunodeficiency virus antibody test (anti-HIV), negative hepatitis B surface antigen (HBsAG) and negative antibody test to hepatitis C virus.
  9. Electrocardiogram (ECG) without clinically significant acute findings (e.g. findings suggestive of current ischemia, ventricular arrhythmias, congestive heart failure and ventricular hypertrophy).

Exclusion Criteria (Main Study):

  1. Pregnant or breast-feeding women.
  2. Uncontrolled serious infection, i.e. not responding to antimicrobial therapy.
  3. History or current clinical manifestation of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject or would limit the subject's ability to complete the trial.

    • History of cerebrovascular disorders, including stroke. Patients with history of transient ischaemic attack (TIA) ≥ 1 year prior to trial participation remain eligible.
    • History of myocardial infarction within ≤ 1 year prior to trial participation, current clinical manifestation of angina pectoris, current clinical manifestation of congestive heart failure ≥ New York Heart Association (NYHA) Grade II, uncontrolled high blood pressure defined as systolic blood pressure ≥ 150 mmHg and/or diastolic ≥ 100 mmHg within the last 2 months.
  4. History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded. Persons with rheumatoid arthritis not requiring immunomodulatory and/or immunosuppressant treatment are not excluded.
  5. Known or suspected impairment of immunologic functions including, but not limited to chronic inflammatory bowel disorders, diabetes mellitus type I.
  6. History of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision at least 6 months ago that is considered to have achieved cure. Subjects with history of skin cancer should not be vaccinated at the previous tumor site.
  7. Clinically significant mental disorder, not adequately controlled by medical treatment.
  8. Active or recent (within the time period of six months before trial participation) history of chronic alcohol abuse and/or intravenous and/or nasal drug abuse.
  9. 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.
  10. Known allergy to eggs or aminoglycosides.
  11. History of anaphylaxis or severe allergic reaction to any vaccine.
  12. Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior to or after trial vaccination.
  13. Having received any vaccinations or planned vaccinations with an inactivated vaccine within 14 days prior to or after trial vaccination.
  14. Chronic systemic administration (defined as more than 14 days) of > 5 mg prednisone (or equivalent)/day or any other immune-modifying drugs during a period starting from three months prior to first administration of the trial vaccination and ending at the last visit of the active trial phase. The use of topical, inhaled, ophthalmic and nasal glucocorticoids is permitted.
  15. Administration or planned administration of immunoglobulins and/or any blood products during a period starting from three months prior to first administration of the trial vaccination and ending at the last visit of the active trial phase.
  16. Use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the first trial vaccination, or planned administration of such a drug between participation in the trial and until 4 weeks after last trial vaccination.
  17. Previous or planned vaccination with a RSV vaccine/vaccine candidate.
  18. Clinical trial personnel working on the current trial.

Inclusion Criteria (Substudy):

  1. Prior to performance of any booster substudy specific procedures, the subject has read, signed and dated an informed consent form, having been advised of the risks and benefits of the trial in a language understood by the subject.
  2. Subject has completed all vaccinations of the main trial according to protocol.

Exclusion Criteria (Substudy):

  1. Any condition that, in the opinion of the investigator, makes it unsafe for the subject to receive a further vaccination.
  2. Pregnancy.
  3. An anaphylactic reaction following the administration of any vaccine(s).
  4. Clinical need for concomitant or ancillary therapy not permitted in the trial as outlined in Protocol Section 8.2.2.
  5. Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior to or after booster vaccination.
  6. Having received any vaccinations or planned vaccinations with an inactivated vaccine within 14 days prior to or after booster vaccination.
  7. Chronic systemic administration (defined as more than 14 days) of > 5 mg prednisone (or equivalent)/day or any other immune-modifying drugs during a period starting from 3 months prior to administration of the booster vaccine and ending at the last visit of the booster active trial phase. The use of topical, inhaled, ophthalmic and nasal glucocorticoids is permitted.
  8. Administration or planned administration of immunoglobulins and/or any blood products during a period starting from 3 months prior to administration of the booster vaccine and ending at the last visit of the booster active trial phase.
  9. Use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the booster vaccination, or planned administration of such a drug during participation in the booster substudy and until 4 weeks after booster vaccination.
  10. Subject's request to discontinue
  11. Subject's refusal to receive booster vaccination.
  12. Subject unwilling or unable to comply with trial requirements. Any reason that, in the opinion of the investigator contradicts administration of the booster vaccination or otherwise requires early discontinuation of a subject.

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): NCT02873286


Locations
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United States, California
Paradigm Research
Redding, California, United States, 96001
Optimal Research
San Diego, California, United States, 92108
United States, Florida
Compass Research
The Villages, Florida, United States, 32162
United States, Georgia
Meridian Clinical Research
Savannah, Georgia, United States, 31406
Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281
United States, Illinois
Optimal Research
Peoria, Illinois, United States, 61614
United States, Maryland
Optimal Research
Rockville, Maryland, United States, 20850
United States, Missouri
Washington University in St. Louis, School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New York
United Medical Associates
Binghamton, New York, United States, 13901
Regional Clinical Research Associates
Endwell, New York, United States, 13760
United States, Ohio
Rapid Medical Research
Cleveland, Ohio, United States, 44122
United States, Texas
Ventavia Research Group
Fort Worth, Texas, United States, 76104
Sponsors and Collaborators
Bavarian Nordic
Investigators
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Principal Investigator: Steven Lawrence, MD Washington University School of Medicine

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Responsible Party: Bavarian Nordic
ClinicalTrials.gov Identifier: NCT02873286     History of Changes
Other Study ID Numbers: RSV-MVA-002
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Bavarian Nordic:
RSV Vaccines
Respiratory Syncytial Virus Vaccines

Additional relevant MeSH terms:
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Virus Diseases
Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs