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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02873286
Recruitment Status : Completed
First Posted : August 19, 2016
Results First Posted : September 22, 2020
Last Update Posted : September 22, 2020
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

Layout table for study information
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 - Single Low Dose / Booster
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
MVA-mBN294B

Other: Placebo
Tris Buffered Saline, sterile

Experimental: Group 2 - Two Low Doses
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
MVA-mBN294B

Experimental: Group 3 - Single High Dose / Booster
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
MVA-mBN294B

Other: Placebo
Tris Buffered Saline, sterile

Experimental: Group 4 - Two High Doses
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
MVA-mBN294B

Experimental: Group 5 - Placebo
First dose (Week 0): placebo; Second dose (Week 4): placebo; (intramuscular vaccinations)
Other: Placebo
Tris Buffered Saline, sterile




Primary Outcome Measures :
  1. PRNT (Subtype A) GMT [ Time Frame: Week 6 (Main Study) i.e., 2 weeks following the second vaccination ]
    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)


Secondary Outcome Measures :
  1. PRNT (Subtype A) GMT [ Time Frame: within 108 weeks ]
    Geometric Mean Titers (GMTs) based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype A). Individual peak is defined as the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Titers below the detection limit (DL) are included with a value of '10' (i.e. 1/2 DL)

  2. Percentage of Participants With Response by PRNT (Subtype A) [ Time Frame: within 108 weeks ]
    Response rate based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype A). Response is defined as the appearance of antibody titers ≥ detection limit (20) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Individual peak response rate is based on the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Percentages based on number of subjects with data available.

  3. PRNT (Subtype B) GMT [ Time Frame: within 108 weeks ]
    Geometric Mean Titers (GMTs) based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype B). Individual peak is defined as the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Titers below the detection limit (DL) are included with a value of '10' (i.e. 1/2 DL)

  4. Percentage of Participants With Response by PRNT (Subtype B) [ Time Frame: within 108 weeks ]
    Response rate based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype B). Response is defined as the appearance of antibody titers ≥ detection limit (20) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Individual peak response rate is based on the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Percentages based on number of subjects with data available.

  5. ELISA (IgG) GMT [ Time Frame: within 108 weeks ]
    Geometric Mean Titers (GMTs) based on RSV-specific Immunoglobulin G (IgG) Enzyme-linked Immunosorbent Assay (ELISA). Individual peak is defined as the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Titers below the detection limit (DL) are included with a value of '31.5' (i.e. 1/2 DL)

  6. Percentage of Participants With Response by IgG ELISA [ Time Frame: within 108 weeks ]
    Response rate based on RSV-specific Immunoglobulin G (IgG) Enzyme-linked Immunosorbent Assay (ELISA). Response is defined as the appearance of antibody titers ≥ detection limit (63) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Individual peak response rate is based on the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Percentages based on number of subjects with data available.

  7. ELISA (IgA) GMT [ Time Frame: within 108 weeks ]
    Geometric Mean Titers (GMTs) based on RSV-specific Immunoglobulin A (IgA) Enzyme-linked Immunosorbent Assay (ELISA). Individual peak is defined as the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Titers below the detection limit (DL) are included with a value of '50' (i.e. 1/2 DL)

  8. Percentage of Participants With Response by IgA ELISA [ Time Frame: within 108 weeks ]
    Response rate based on RSV-specific Immunoglobulin A (IgA) Enzyme-linked Immunosorbent Assay (ELISA). Response is defined as the appearance of antibody titers ≥ detection limit (100) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Individual peak response rate is based on the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Percentages based on number of subjects with data available.

  9. ELISA (Mucosal IgA) GMT [ Time Frame: within 82 weeks ]
    Geometric Mean Titers (GMTs) based on mucosal RSV-specific Immunoglobulin A (IgA) Enzyme-linked Immunosorbent Assay (ELISA). Individual peak is defined as the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Titers below the detection limit (DL) are included with a value of '1' (i.e. 1/2 DL)

  10. Percentage of Participants With Response by Mucosal IgA ELISA [ Time Frame: within 82 weeks ]
    Response rate based on mucosal RSV-specific Immunoglobulin A (IgA) Enzyme-linked Immunosorbent Assay (ELISA). Response is defined as the appearance of antibody titers ≥ detection limit (2) for initially negative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Individual peak response rate is based on the maximum post-Baseline antibody titer up to the end of the respective active trial phase i.e., within 8 weeks for the main study and within 4 weeks for the booster substudy. Percentages based on number of subjects with data available.

  11. ELISPOT (IFN-g, Peptide Pool: F) GMSFU [ Time Frame: within 58 weeks ]
    Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool F. Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

  12. ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU [ Time Frame: within 58 weeks ]
    Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(A). Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

  13. ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU [ Time Frame: within 58 weeks ]
    Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(B). Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

  14. ELISPOT (IFN-g, Peptide Pool: M2) GMSFU [ Time Frame: within 58 weeks ]
    Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool M2. Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

  15. ELISPOT (IFN-g, Peptide Pool: N) GMSFU [ Time Frame: within 58 weeks ]
    Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool N. Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

  16. ELISPOT (IL-4, Peptide Pool: F) GMSFU [ Time Frame: within 58 weeks ]
    Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool F. Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

  17. ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU [ Time Frame: within 58 weeks ]
    Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(A). Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

  18. ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU [ Time Frame: within 58 weeks ]
    Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(B). Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

  19. ELISPOT (IL-4, Peptide Pool: M2) GMSFU [ Time Frame: within 58 weeks ]
    Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool M2. Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

  20. ELISPOT (IL-4, Peptide Pool: N) GMSFU [ Time Frame: within 58 weeks ]
    Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool N. Values below the detection limit (DL) are included with a value of '25' (i.e. 1/2 DL)

  21. Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F) [ Time Frame: within 58 weeks ]
    Response rate based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool F. Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

  22. Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A)) [ Time Frame: within 58 weeks ]
    Response rate based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(A). Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

  23. Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B)) [ Time Frame: within 58 weeks ]
    Response rate based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(B). Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

  24. Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2) [ Time Frame: within 58 weeks ]
    Response rate based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool M2. Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

  25. Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N) [ Time Frame: within 58 weeks ]
    Response rate based on RSV-specific Interferon-gamma (IFN-g) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool N. Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

  26. Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F) [ Time Frame: within 58 weeks ]
    Response rate based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool F. Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

  27. Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A)) [ Time Frame: within 58 weeks ]
    Response rate based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(A). Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

  28. Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B)) [ Time Frame: within 58 weeks ]
    Response rate based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool G(B). Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

  29. Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2) [ Time Frame: within 58 weeks ]
    Response rate based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool M2. Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

  30. Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N) [ Time Frame: within 58 weeks ]
    Response rate based on RSV-specific Interleukin 4 (IL-4) Enzyme-linked Immuno Spot Technique (ELISPOT) for the Peptide Pool N. Response is defined as the appearance of spot forming units ≥ detection limit (50) for initially negative subjects, or a doubling or more of the spot forming units compared to Baseline for initially positive subjects. Response for main study visits is based on main study Baseline, whereas response for booster study visits is based on booster substudy Baseline. Percentages based on number of subjects with paired data available, i.e. number of subjects with results available for the respective time point and the corresponding Baseline.

  31. Memory B Cells (IgG) GMSFU [ Time Frame: within 82 weeks ]
    Geometric Mean Spot Forming Units (GMSFUs) based on RSV-specific Immunoglobulin G (IgG)-producing memory B cells. Negative results (i.e. results below 0.01) are included with a value of '0.005'

  32. Serious Adverse Events [ Time Frame: within 108 weeks (Main Study + Booster Substudy) ]
    Number of participants reporting Serious Adverse Events per period: Between 1st and 2nd vaccination (Vaccination Period 1, Main Study, duration: 4 weeks), between 2nd vaccination and end of active phase of the Main Study (Vaccination Period 2, Main Study, duration: 4 weeks), during the follow-up phase of the Main Study (Follow-Up, Main Study, duration: 22 weeks), after the Main Study and before the booster vaccination (Between Study Parts [retrospectively collected in booster substudy], duration: 26 weeks), between booster vaccination and end of active phase of the Booster Substudy (Booster Vaccination Period, Booster Substudy, duration: 4 weeks), and during the follow-up phase of the Booster Substudy (Follow-Up, Booster Substudy, duration: 48 weeks). Percentages based on number of subjects still in the study at the start of the respective period.

  33. Related Serious Adverse Events [ Time Frame: within 108 weeks (Main Study + Booster Substudy) ]
    Number of participants reporting Serious Adverse Events possibly, probably or definitely related to the trial vaccine per period: Between 1st and 2nd vaccination (Vaccination Period 1, Main Study, duration: 4 weeks), between 2nd vaccination and end of active phase of the Main Study (Vaccination Period 2, Main Study, duration: 4 weeks), during the follow-up phase of the Main Study (Follow-Up, Main Study, duration: 22 weeks), after the Main Study and before the booster vaccination (Between Study Parts [retrospectively collected in booster substudy], duration: 26 weeks), between booster vaccination and end of active phase of the Booster Substudy (Booster Vaccination Period, Booster Substudy, duration: 4 weeks), and during the follow-up phase of the Booster Substudy (Follow-Up, Booster Substudy, duration: 48 weeks). Percentages based on number of subjects still in the study at the start of the respective period.

  34. Grade ≥ 3 Serious Adverse Events [ Time Frame: within 108 weeks (Main Study + Booster Substudy) ]
    Number of participants reporting Serious Adverse Events with intensity ≥ Grade 3 per period: Between 1st and 2nd vaccination (Vaccination Period 1, Main Study, duration: 4 weeks), between 2nd vaccination and end of active phase of the Main Study (Vaccination Period 2, Main Study, duration: 4 weeks), during the follow-up phase of the Main Study (Follow-Up, Main Study, duration: 22 weeks), after the Main Study and before the booster vaccination (Between Study Parts [retrospectively collected in booster substudy], duration: 26 weeks), between booster vaccination and end of active phase of the Booster Substudy (Booster Vaccination Period, Booster Substudy, duration: 4 weeks), and during the follow-up phase of the Booster Substudy (Follow-Up, Booster Substudy, duration: 48 weeks). Percentages based on number of subjects still in the study at the start of the respective period.

  35. Related Grade ≥ 3 Adverse Events [ Time Frame: within 29 days after vaccination ]
    Number of participants reporting Adverse Events possibly, probably or definitely related to the trial vaccine with intensity ≥ Grade 3 per period: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Pooled solicited (general only) and unsolicited AEs. Percentages based on number of subjects still in the study at the start of the respective period.

  36. Solicited Local Adverse Events [ Time Frame: within 8 days after vaccination ]
    Incidence of injection site reactions (solicited via diary cards) after vaccination: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects with a completed diary card for the respective vaccination period.

  37. Grade ≥ 3 Solicited Local Adverse Events [ Time Frame: within 8 days after vaccination ]
    Incidence of injection site reactions (solicited via diary cards) with intensity ≥ Grade 3 after vaccination: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects with a completed diary card for the respective vaccination period.

  38. Solicited General Adverse Events [ Time Frame: within 8 days after vaccination ]
    Incidence of systemic reactions (solicited via diary cards) after vaccination: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects with a completed diary card for the respective vaccination period.

  39. Grade ≥ 3 Solicited General Adverse Events [ Time Frame: within 8 days after vaccination ]
    Incidence of systemic reactions (solicited via diary cards) with intensity ≥ Grade 3 after vaccination: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects with a completed diary card for the respective vaccination period.

  40. Related Solicited General Adverse Events [ Time Frame: within 8 days after vaccination ]
    Incidence of systemic reactions (solicited via diary cards) possibly, probably or definitely related to the trial vaccine after vaccination: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects with a completed diary card for the respective vaccination period.

  41. Unsolicited Non-serious Adverse Events [ Time Frame: within 29 days after vaccination ]
    Incidence of unsolicited non-serious adverse events by period: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects having received the respective vaccination.

  42. Related Unsolicited Non-serious Adverse Events [ Time Frame: within 29 days after vaccination ]
    Incidence of unsolicited non-serious adverse events possibly, probably or definitely related to the trial vaccine by period: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects having received the respective vaccination.

  43. Grade ≥ 3 Unsolicited Non-serious Adverse Events [ Time Frame: within 29 days after vaccination ]
    Incidence of unsolicited non-serious adverse events with intensity ≥ Grade 3 by period: Following the 1st vaccination (Vaccination Period 1, Main Study), following the 2nd vaccination (Vaccination Period 2, Main Study), and following the booster vaccination (Booster Vaccination Period, Booster Substudy). Percentages based on number of subjects having received the respective vaccination.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
  Study Documents (Full-Text)

Documents provided by Bavarian Nordic:
Statistical Analysis Plan  [PDF] May 1, 2018
Study Protocol  [PDF] April 26, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bavarian Nordic
ClinicalTrials.gov Identifier: NCT02873286    
Other Study ID Numbers: RSV-MVA-002
First Posted: August 19, 2016    Key Record Dates
Results First Posted: September 22, 2020
Last Update Posted: September 22, 2020
Last Verified: September 2020
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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Respiratory Syncytial Virus Infections
Virus Diseases
Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections