NCT02864628

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2016

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2017

Completed
Last Updated

August 27, 2018

Status Verified

August 1, 2018

Enrollment Period

1.2 years

First QC Date

August 9, 2016

Last Update Submit

August 23, 2018

Conditions

Respiratory Syncytial Virus Infections

Keywords

RSV VaccinesRespiratory Syncytial Virus Vaccines

Outcome Measures

Primary Outcomes (1)

  • Occurrence of serious adverse events

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

    Screening up to week 34 after first vaccination

Secondary Outcomes (1)

  • RSV-specific humoral immune response

    humoral immune response is measured up to week 34

Study Arms (5)

Group 1

EXPERIMENTAL

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

Biological: MVA-BN-RSVOther: Placebo

Group 2

EXPERIMENTAL

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

Biological: MVA-BN-RSVOther: Placebo

Group 3

EXPERIMENTAL

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

Biological: MVA-BN-RSVOther: Placebo

Group 4

EXPERIMENTAL

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

Biological: MVA-BN-RSV

Group 5

EXPERIMENTAL

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

Biological: MVA-BN-RSV

Interventions

MVA-BN-RSVBIOLOGICAL

MVA-mBN294B

Group 1Group 2Group 3Group 4Group 5
PlaceboOTHER

Tris Buffered Saline

Group 1Group 2Group 3

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Carlos Fierro, MD

    Johnson County Clin-Trials (JCCT)

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2016

First Posted

August 12, 2016

Study Start

September 1, 2016

Primary Completion

October 27, 2017

Study Completion

October 27, 2017

Last Updated

August 27, 2018

Record last verified: 2018-08