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

NCT02873286 | Completed Phase 2 Results DMC

• 1 other identifier: RSV-MVA-002
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 12

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.

Conditions

Respiratory Syncytial Virus Infections

Keywords

RSV Vaccines; Respiratory Syncytial Virus Vaccines

Outcome Measures

Primary Outcomes (1)

• PRNT (Subtype A) GMT

  Geometric Mean Titers (GMTs) based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype A). Titers below the detection limit (DL) are included with a value of '10' (i.e. 1/2 DL)

  Week 6 (Main Study) i.e., 2 weeks following the second vaccination

Secondary Outcomes (43)

• PRNT (Subtype A) GMT

  within 108 weeks

• Percentage of Participants With Response by PRNT (Subtype A)

  within 108 weeks

• PRNT (Subtype B) GMT

  within 108 weeks

• Percentage of Participants With Response by PRNT (Subtype B)

  within 108 weeks

• ELISA (IgG) GMT

  within 108 weeks

Study Arms (5)

Group 1 - Single Low Dose / Booster

EXPERIMENTAL

First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)

Biological: MVA-BN-RSV; Other: Placebo

Group 2 - Two Low Doses

EXPERIMENTAL

First dose (Week 0): MVA-BN-RSV 1x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 1x10E8 Inf.U; (intramuscular vaccinations)

Biological: MVA-BN-RSV

Group 3 - Single High Dose / Booster

EXPERIMENTAL

First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): placebo; Booster dose (Week 56): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)

Biological: MVA-BN-RSV; Other: Placebo

Group 4 - Two High Doses

EXPERIMENTAL

First dose (Week 0): MVA-BN-RSV 5x10E8 Inf.U; Second dose (Week 4): MVA-BN-RSV 5x10E8 Inf.U; (intramuscular vaccinations)

Biological: MVA-BN-RSV

Group 5 - Placebo

EXPERIMENTAL

First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)

Other: Placebo

Interventions

MVA-BN-RSV BIOLOGICAL

MVA-mBN294B

Group 1 - Single Low Dose / Booster; Group 2 - Two Low Doses; Group 3 - Single High Dose / Booster; Group 4 - Two High Doses

Placebo OTHER

Tris Buffered Saline, sterile

Group 1 - Single Low Dose / Booster; Group 3 - Single High Dose / Booster; Group 5 - Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects, ≥ 55 years of age.
• 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.
• 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.
• Able to comply with trial requirements; including access to transportation for trial visits.
• Body mass index (BMI) ≥ 18.5 and ≤ 39.9
• BMI formula for pounds and inches:
• BMI = (bodyweight in pounds) \* 703 (bodyheight in inches)2
• 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
• Not clinically significant laboratory values as defined in the protocol, excluding any Grade ≥ 3 toxicity.
• Negative human immunodeficiency virus antibody test (anti-HIV), negative hepatitis B surface antigen (HBsAG) and negative antibody test to hepatitis C virus.
• Electrocardiogram (ECG) without clinically significant acute findings (e.g. findings suggestive of current ischemia, ventricular arrhythmias, congestive heart failure and ventricular hypertrophy).

You may not qualify if:

• Pregnant or breast-feeding women.
• Uncontrolled serious infection, i.e. not responding to antimicrobial therapy.
• 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.
• 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.
• Known or suspected impairment of immunologic functions including, but not limited to chronic inflammatory bowel disorders, diabetes mellitus type I.
• 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.
• Clinically significant mental disorder, not adequately controlled by medical treatment.
• 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.
• 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.
• Known allergy to eggs or aminoglycosides.
• History of anaphylaxis or severe allergic reaction to any vaccine.
• Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior to or after trial vaccination.
• Having received any vaccinations or planned vaccinations with an inactivated vaccine within 14 days prior to or after trial vaccination.

Sponsors & Collaborators

• Bavarian Nordic: lead

Study Sites (12)

Paradigm Research

Redding, California, 96001, United States

Location

Optimal Research

San Diego, California, 92108, United States

Location

Compass Research

The Villages, Florida, 32162, United States

Location

Meridian Clinical Research

Savannah, Georgia, 31406, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Optimal Research

Peoria, Illinois, 61614, United States

Location

Optimal Research

Rockville, Maryland, 20850, United States

Location

Washington University in St. Louis, School of Medicine

St Louis, Missouri, 63110, United States

Location

United Medical Associates

Binghamton, New York, 13901, United States

Location

Regional Clinical Research Associates

Endwell, New York, 13760, United States

Location

Rapid Medical Research

Cleveland, Ohio, 44122, United States

Location

Ventavia Research Group

Fort Worth, Texas, 76104, United States

Location

Related Publications (1)

• Jordan E, Lawrence SJ, Meyer TPH, Schmidt D, Schultz S, Mueller J, Stroukova D, Koenen B, Gruenert R, Silbernagl G, Vidojkovic S, Chen LM, Weidenthaler H, Samy N, Chaplin P. Broad Antibody and Cellular Immune Response From a Phase 2 Clinical Trial With a Novel Multivalent Poxvirus-Based Respiratory Syncytial Virus Vaccine. J Infect Dis. 2021 Mar 29;223(6):1062-1072. doi: 10.1093/infdis/jiaa460.

  PMID: 32726422 DERIVED

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Program Lead, Clinical Operations
• Organization: Bavarian Nordic A/S

info@bavarian-nordic.com

+45 3326

Study Officials

• Steven Lawrence, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 19, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 22, 2020
• Results First Posted: September 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)