CClinicalTrials.gg
Sign In
WithdrawnNCT02864628Updated Aug 27, 2018

RSV-MVA-BN Vaccine Phase I Trial, Intranasal Application in Adults.

A Phase 1 interventional study of MVA-BN-RSV and Placebo in Respiratory Syncytial Virus Infections, sponsored by Bavarian Nordic. Withdrawn. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-27.

Sponsored by Bavarian Nordic · Phase 1, Interventional, and Prevention

Why this study was withdrawn
Protocol was withdrawn from IND
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Study summary

A total of 96 subjects will be recruited into 5 groups. Each subject will receive either two vaccinations with MVA-BN-RSV vaccine or placebo.

02

Conditions studied

  • Respiratory Syncytial Virus Infections

Keywords

  • RSV Vaccines
  • Respiratory Syncytial Virus Vaccines
03

In context

Respiratory Syncytial Virus Infections

293 studies on the registry are indexed under Respiratory Syncytial Virus Infections; 45 are open to participants now.

Browse Respiratory Syncytial Virus Infections studies →

Lead sponsor

Bavarian Nordic is the lead sponsor of 55 studies on the registry; 1 is open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 12 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • signed and dated an informed consent form and HIPAA.
  • Subjects without symptomatic cardiopulmonary and/or metabolic disease.
  • Body mass index (BMI) ≥ 18.5 and ≤ 34.9.
  • Negative human immunodeficiency virus antibody test (anti-HIV), HBsAG and HCV virus.
  • Electrocardiogram (ECG) without clinically significant acute findings.
  • WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to each vaccination.

Exclusion criteria

Exclusion Criteria:

  • History of nasal or sinus surgery within six months prior to screening or planned nasal or sinus surgery during the trial
  • Active or recent history (within 6 months prior to screening) of chronic sinusitis, nasopharyngeal abnormalities and/or symptoms such as polyps or deviated septum
  • pregnant or breast-feeding women.
  • History or current clinical manifestation of any serious medical condition.
  • History of or active autoimmune disease.
  • Known or suspected impairment of immunologic functions including, but not limited to chronic inflammatory bowel disorders, diabetes mellitus type I.
  • Knowledge/history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • History of anaphylaxis or severe allergic reaction to any vaccine.
  • Chronic systemic administration defined as more than 14 days of > 5 mg prednisone per day
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Group 1

    ≥55 year old healthy subjects, receiving either 5x10E7 TCID50 MVA-BN-RSV or Placebo intranasal application

    Biological: MVA-BN-RSV · Other: Placebo

  • Experimental
    Group 2

    ≥55 year old healthy subjects, receiving either 1x10E8 TCID50 MVA-BN-RSV or Placebo intranasal application

    Biological: MVA-BN-RSV · Other: Placebo

  • Experimental
    Group 3

    ≥55 year old healthy subjects, receiving either 5x10E8 TCID50 MVA-BN-RSV or Placebo intranasal application

    Biological: MVA-BN-RSV · Other: Placebo

  • Experimental
    Group 4

    ≥55 year old healthy subjects, receiving 5x10E8 TCID50 MVA-BN-RSV intranasal and intramuscular application

    Biological: MVA-BN-RSV

  • Experimental
    Group 5

    ≥55 year old healthy subjects, receiving 5x10E8 TCID50 MVA-BN-RSV intramuscular application

    Biological: MVA-BN-RSV

Interventions

  • BiologicalMVA-BN-RSV

    MVA-mBN294B

  • OtherPlacebo

    Tris Buffered Saline

06

What researchers measure

Primary outcomes

  1. Occurrence of serious adverse events

    Occurrence, relationship to the trial vaccine and intensity of any serious adverse event (SAE).

    Time frame: Screening up to week 34 after first vaccination

Secondary outcomes

  1. RSV-specific humoral immune response

    To assess the RSV-specific serum antibody responses

    Time frame: humoral immune response is measured up to week 34

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02864628
Lead sponsor
Bavarian Nordic
Responsible party
Sponsor
First posted
Aug 12, 2016
Start date
Sep 2016 (estimated)
Primary completion
Oct 27, 2017
Completion
Oct 27, 2017
Last update
Aug 27, 2018

Study contacts

Carlos Fierro, MD
principal investigator · Johnson County Clin-Trials (JCCT)

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Respiratory Syncytial Virus Infections→

Other studies from this sponsor

Bavarian Nordic

Start the discussion