Clincosm LogoSign in Get a demo

MVA-BN-RSV Vaccine Trial

Sponsor
Bavarian Nordic (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05238025
Collaborator
(none)
20,000
Enrollment
79
Locations
2
Arms
31.4
Anticipated Duration (Months)
253.2
Patients Per Site
8.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Biological: MVA-BN-RSV vaccine
  • Biological: Tris Buffered Saline (TBS)
 Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Apr 19, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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

Primary Outcome Measures

  1. Occurrence of LRTD [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 [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 [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 [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 [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 [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 [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 [Within 29 days after vaccination]

    Occurrence of any unsolicited adverse events within 29 days after vaccination.

  8. RSV-specific T-cell responses [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 [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 [Within 2 weeks after vaccination]

    RSV-specific serum neutralizing antibody titers 2 weeks post vaccination (subtype A and B)

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

  1. 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.

  1. Previous vaccination with an RSV vaccine, or any planned vaccination with an RSV vaccine other than the trial vaccine.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Involvement with this trial as research personnel.

Contacts and Locations

Locations

Site City State Country Postal Code
1 North Alabama Research Center, LLC Athens Alabama United States 35611
2 Central Alabama Research Birmingham Alabama United States 35209
3 Achieve Clinical Research, LLC d/b/a Accel Research Sites Birmingham Alabama United States 35216
4 Medical Affiliation Research Center Huntsville Alabama United States 35801
5 Aventiv Research Inc. Mesa Arizona United States 85210
6 Phoenix Clinical LLC Phoenix Arizona United States 85014
7 Pain Center of Arizona Phoenix Arizona United States 85018
8 Cognitive Clinical Trials, LLC Phoenix Arizona United States 85044
9 Fiel Family and Sports Medicine/CCT Research Tempe Arizona United States 85283
10 HOPE Research Institute Tempe Arizona United States 85284
11 Hope Clinical Research, LLC Canoga Park California United States 91303
12 Marvel Clinical Research 002, LLC Huntington Beach California United States 92647
13 Join Clinical Trials Huntington Park California United States 90255
14 Paradigm Clinical Research Center La Mesa California United States 91942
15 Atella Clinical Research LLC La Palma California United States 90623
16 ARK Clinical Research Long Beach California United States 90806
17 Artemis Institute for Clinical Research San Diego California United States 92103
18 California Research Foundation San Diego California United States 92123
19 Diablo Clinical Research, Inc. Walnut Creek California United States 94598
20 Lynn Institute of Denver Aurora Colorado United States 80012
21 Innovative Research Of West Florida, Inc. Clearwater Florida United States 33756
22 Doral Medical Research Hialeah Florida United States 33016
23 K2 Medical Research, LLC Maitland Florida United States 32751
24 Global Health Research Center, Inc Miami Lakes Florida United States 33016
25 De La Cruz Research Center, LLC Miami Florida United States 33184
26 Pines Care Research Center, LLC Pembroke Pines Florida United States 33024
27 IDEAL Clinical Research Pembroke Pines Florida United States 33026
28 Centricity Research Columbus Multispecialty Columbus Georgia United States 31904
29 Meridian Clinical Research, LLC Savannah Georgia United States 31406
30 Bingham Memorial Hospital Blackfoot Idaho United States 83221
31 Clinical Research Prime Idaho Falls Idaho United States 83404
32 Snake River Research, PLLC Idaho Falls Idaho United States 83404
33 Great Lakes Clinical Trials at Ravenswood Rheumatology Chicago Illinois United States 60625
34 Accelacare- DuPage Medical Group Oak Lawn Illinois United States 60453
35 Centennial Medical Group Elkridge Maryland United States 21075
36 Meridian Clinical Research Rockville Maryland United States 20854
37 The Clinical Research Center, LLC Saint Louis Missouri United States 63141
38 Meridian Clinical Research, LLC Grand Island Nebraska United States 68803
39 Meridian Clinical Research, LLC Norfolk Nebraska United States 68701
40 University Of Nebraska Medical Center Omaha Nebraska United States 68105
41 Quality Clinical Research Inc Omaha Nebraska United States 68114
42 Meridian Clinical Research Associates, LLC Omaha Nebraska United States 68134
43 Midwest Regional Health Services, LLC/CCT Research Omaha Nebraska United States 68144
44 Excel Clinical Research Las Vegas Nevada United States 89109
45 Santa Rosa Medical Centers of Nevada/ CCT Research Las Vegas Nevada United States 89119
46 MedPharmics, LLC Albuquerque New Mexico United States 87102
47 Certified Research Associates Cortland New York United States 13045
48 Meridian Clinical Research LLC Endwell New York United States 13760
49 CHEAR Center LLC New York New York United States 10455
50 Rochester Clinical Research Inc. Rochester New York United States 14609
51 Accellacare - Raleigh Medical Group Cary North Carolina United States 27518
52 PharmQuest Greensboro North Carolina United States 27408
53 Accellacare - Raleigh Medical Group Raleigh North Carolina United States 27609
54 Accellacare - Piedmont Statesville North Carolina United States 28625
55 Accellacare of Wilmington Wilmington North Carolina United States 28401
56 Progressive Medicine of the Triad, LLC Winston-Salem North Carolina United States 27103
57 CTI Clinical Research Center Cincinnati Ohio United States 45212
58 Velocity Clinical Research Cincinnati Ohio United States 45242
59 Lynn Health Science Institute Oklahoma City Oklahoma United States 73112
60 Tekton Research Inc. Yukon Oklahoma United States 73099
61 Capital Area Research, LLC Camp Hill Pennsylvania United States 17011
62 Velocity Clinical Research- Providence East Greenwich Rhode Island United States 02818
63 Velocity Clinical Research Anderson Anderson South Carolina United States 29621
64 Accellacare of Knoxville Knoxville Tennessee United States 37938
65 Tekton Research, Inc. Austin Texas United States 78745
66 Invesclinic US LLC Edinburg Texas United States 78539
67 DM Clinical Research Houston Texas United States 77065
68 SMS Clinical Research Mesquite Texas United States 75149
69 Research Your Health Plano Texas United States 75093
70 Be Well Clinical Studies Round Rock Texas United States 78681
71 Mt Olympus Medical Research LLC Sugar Land Texas United States 77479
72 DM Clinical Research Tomball Texas United States 77375
73 Tanner Clinic Layton Utah United States 84041
74 South Ogden Family Medicine/ CCT Research Ogden Utah United States 84405
75 Velocity Clinical Research, Salt Lake City West Jordan Utah United States 84088
76 Clinical Alliance for Research and Education Infectious Disease Annandale Virginia United States 22003-7347
77 Meridian Clinical Research, LLC Portsmouth Virginia United States 23703
78 Centricity Research Suffolk Primary Care Suffolk Virginia United States 23435
79 Sound Medical Research Port Orchard Washington United States 98366

Sponsors and Collaborators

  • Bavarian Nordic

Investigators

  • Study Director: Bernard Hoet, MD, Bavarian Nordic GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bavarian Nordic
ClinicalTrials.gov Identifier:
NCT05238025
Other Study ID Numbers:
  • RSV-MVA-004
First Posted:
Feb 14, 2022
Last Update Posted:
Aug 1, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Respiratory Syncytial Virus Infections

Study Results

No Results Posted as of Aug 1, 2022