Respiratory Syncytial Virus InfectionsPhase 1NCT02419391
Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant MVA BN® RSV Vaccine
A Phase 1 study testing MVA BN RSV in people with Respiratory Syncytial Virus Infections, run by Bavarian Nordic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- MVA BN RSV
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to May 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johnson County Clin-Trials (JCCT)
Lenexa, Kansas, 66219
About this study
Official title: 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
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.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- MVA BN RSV, Placebo
- Keywords
- RSV Vaccines, Respiratory Syncytial Virus Vaccines
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVA BN RSVBiological
Also called MVA-mBN294B
Liquid frozen suspension of MVA-mBN294B
PlaceboOther
Also called TBS
Tris Buffered Saline, sterile
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 18-49 year old healthy subjects, receiving either 1x10E7TCID50 MVA BN RSV or Placebo Receives: Biological: MVA BN RSV; Other: Placebo |
| Group 2 | Experimental | 18-49 year old healthy subjects, receiving either 1x10E8TCID50 MVA BN RSV or Placebo Receives: Biological: MVA BN RSV; Other: Placebo |
| Group 3 | Experimental | 50-65 year old healthy subjects, receiving either 1x10E8TCID50 MVA BN RSV or Placebo Receives: Biological: MVA BN RSV; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of serious adverse events
Occurrence, relationship to the trial vaccine and intensity of any serious adverse event (SAE).
Measured: 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.
Measured: 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
Measured: 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
Measured: within four weeks after each vaccination
Solicited general adverse events
Occurrence, relationship to the trial vaccine, intensity and duration of solicited general adverse events
Measured: day of vaccination and the following seven days
Secondary outcomes (5)
Vaccinia-specific cellular immune responses.
To assess the RSV-specific and vaccinia-specific cellular immune responses against the MVA-BN RSV vaccine in healthy adult subjects. Spot forming units will be determined by using an IFN-γ ELISPOT assay.
Measured: cellular immune response measured up to week 4 after 2nd vaccination
RSV-specific humoral immune response
To assess the RSV-specific serum antibody responses by ELISA
Measured: humoral immune response is measured up to week 34
RSV-specific humoral immune response
To assess the RSV-specific serum antibody responses by PRNT
Measured: humoral immune response is measured up to week 34
RSV-specific humoral immune response
To assess the RSV-specific mucosal antibody responses by ELISA
Measured: humoral immune response is measured up to week 34
Vaccinica-specific humoral immune response
To assess the Vaccinica-specific serum antibody responses by ELISA
Measured: humoral immune response is measured up to week 34
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bavarian Nordic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Casey Johnson, DO, Principal investigator, Johnson County Clin-Trials (JCCT)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419391
- Sponsor's protocol ID
- RSV-MVA-001
- Status last verified
- Aug 2016
- First submitted
- 7 Apr 2015
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02419391
- Acronym / sponsor ID
- RSV-MVA-001
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- RSV Vaccines, Respiratory Syncytial Virus Vaccines
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Bavarian NordicIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: MVA BN RSV, Other: Placebo18-49 year old healthy subjects, receiving either 1x10E7TCID50 MVA BN RSV or Placebo |
| Group 2 | Experimental | Biological: MVA BN RSV, Other: Placebo18-49 year old healthy subjects, receiving either 1x10E8TCID50 MVA BN RSV or Placebo |
| Group 3 | Experimental | Biological: MVA BN RSV, Other: Placebo50-65 year old healthy subjects, receiving either 1x10E8TCID50 MVA BN RSV or Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MVA BN RSVAlso: MVA-mBN294BLiquid frozen suspension of MVA-mBN294B | Biological | Group 1, Group 2, Group 3 |
| PlaceboAlso: TBSTris Buffered Saline, sterile | Other | Group 1, Group 2, Group 3 |
Primary outcome
Occurrence of serious adverse events
Time frame: Screening up to week 34 after first vaccination
Occurrence, relationship to the trial vaccine and intensity of any serious adverse event (SAE).
Occurrence of grade 3 adverse events
Time frame: Screening up to week 8 after first vaccination
Occurrence of any grade 3 or higher adverse events possibly, probably or definitely related to the trial vaccine within four weeks after each vaccination.
Solicited local adverse events
Time frame: day of vaccination and the following seven days
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
Unsolicited non-serious adverse events
Time frame: within four weeks after each vaccination
Occurrence, relationship to the trial vaccine and intensity of unsolicited non-serious adverse events
Solicited general adverse events
Time frame: day of vaccination and the following seven days
Occurrence, relationship to the trial vaccine, intensity and duration of solicited general adverse events
5 secondary outcomes
Vaccinia-specific cellular immune responses.
Time frame: cellular immune response measured up to week 4 after 2nd vaccination
RSV-specific humoral immune response
Time frame: humoral immune response is measured up to week 34
RSV-specific humoral immune response
Time frame: humoral immune response is measured up to week 34
RSV-specific humoral immune response
Time frame: humoral immune response is measured up to week 34
Vaccinica-specific humoral immune response
Time frame: humoral immune response is measured up to week 34
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Casey Johnson, DO principal investigator
Johnson County Clin-Trials (JCCT)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MVA BN RSV in people with Respiratory Syncytial Virus Infections, run by Bavarian Nordic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of serious adverse events (time frame: Screening up to week 34 after first vaccination). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2016.