Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant MVA BN® RSV Vaccine
A Randomized, Single-blind, Placebo-controlled Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant MVA BN® RSV Vaccine in Healthy Adult Subjects
1 other identifier
interventional
63
1 country
1
Brief Summary
A total of 63 subjects will be recruited into three groups (18 subjects per group will receive MVA BN RSV vaccine and three subjects per group will receive placebo). Liquid frozen suspension of MVA BN RSV. Each subject will receive two vaccinations with either MVA-BN RSV vaccine 1 x 108 TCID50 per 0.5 ml, 1 x 107 TCID50 per 0.5 ml or with placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2015
1 active site
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
April 7, 2015
CompletedFirst Posted
Study publicly available on registry
April 17, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedAugust 10, 2016
August 1, 2016
4 months
April 7, 2015
August 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
Occurrence of grade 3 adverse events
Occurrence of any grade 3 or higher adverse events possibly, probably or definitely related to the trial vaccine within four weeks after each vaccination.
Screening up to week 8 after first vaccination
Solicited local adverse events
Occurrence, intensity and duration of solicited local adverse events after each vaccination Occurrence, intensity and duration of solicited local adverse events after each vaccination Occurrence, intensity and duration of solicited local adverse events after each vaccination
day of vaccination and the following seven days
Unsolicited non-serious adverse events
Occurrence, relationship to the trial vaccine and intensity of unsolicited non-serious adverse events
within four weeks after each vaccination
Solicited general adverse events
Occurrence, relationship to the trial vaccine, intensity and duration of solicited general adverse events
day of vaccination and the following seven days
Secondary Outcomes (5)
Vaccinia-specific cellular immune responses.
cellular immune response measured up to week 4 after 2nd vaccination
RSV-specific humoral immune response
humoral immune response is measured up to week 34
RSV-specific humoral immune response
humoral immune response is measured up to week 34
RSV-specific humoral immune response
humoral immune response is measured up to week 34
Vaccinica-specific humoral immune response
humoral immune response is measured up to week 34
Study Arms (3)
Group 1
EXPERIMENTAL18-49 year old healthy subjects, receiving either 1x10E7TCID50 MVA BN RSV or Placebo
Group 2
EXPERIMENTAL18-49 year old healthy subjects, receiving either 1x10E8TCID50 MVA BN RSV or Placebo
Group 3
EXPERIMENTAL50-65 year old healthy subjects, receiving either 1x10E8TCID50 MVA BN RSV or Placebo
Interventions
Liquid frozen suspension of MVA-mBN294B
Eligibility Criteria
You may qualify if:
- signed and dated an informed consent form
- Body mass index ≥ 18.5 and \< 35.
- Women of childbearing potential (WOCBP) must have used an acceptable method of contraception
You may not qualify if:
- Pregnant or breast-feeding women.
- Uncontrolled serious infection, i.e. not responding to antimicrobial therapy.
- History of any serious medical condition.
- History of or active autoimmune disease.
- Known or suspected impairment of immunologic functions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bavarian Nordiclead
Study Sites (1)
Johnson County Clin-Trials (JCCT)
Lenexa, Kansas, 66219, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Casey Johnson, DO
Johnson County Clin-Trials (JCCT)
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
April 7, 2015
First Posted
April 17, 2015
Study Start
August 1, 2015
Primary Completion
December 1, 2015
Study Completion
May 1, 2016
Last Updated
August 10, 2016
Record last verified: 2016-08