Respiratory Syncytial Virus InfectionsPhase 1NCT02864628
RSV-MVA-BN Vaccine Phase I Trial, Intranasal Application in Adults.
A Phase 1 study testing MVA-BN-RSV in people with Respiratory Syncytial Virus Infections, run by Bavarian Nordic.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- MVA-BN-RSV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to 27 Oct 2017
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
About this study
Official title: A Partially Randomized, Partly Placebo Controlled Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant MVA-BN® RSV Vaccine After Intranasal and Intramuscular Administration
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.
- 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
MVA-mBN294B
PlaceboOther
Tris Buffered Saline
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | ≥55 year old healthy subjects, receiving either 5x10E7 TCID50 MVA-BN-RSV or Placebo intranasal application Receives: Biological: MVA-BN-RSV; Other: Placebo |
| Group 2 | Experimental | ≥55 year old healthy subjects, receiving either 1x10E8 TCID50 MVA-BN-RSV or Placebo intranasal application Receives: Biological: MVA-BN-RSV; Other: Placebo |
| Group 3 | Experimental | ≥55 year old healthy subjects, receiving either 5x10E8 TCID50 MVA-BN-RSV or Placebo intranasal application Receives: Biological: MVA-BN-RSV; Other: Placebo |
| Group 4 | Experimental | ≥55 year old healthy subjects, receiving 5x10E8 TCID50 MVA-BN-RSV intranasal and intramuscular application Receives: Biological: MVA-BN-RSV |
| Group 5 | Experimental | ≥55 year old healthy subjects, receiving 5x10E8 TCID50 MVA-BN-RSV intramuscular application Receives: Biological: MVA-BN-RSV |
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
Secondary outcomes (1)
RSV-specific humoral immune response
To assess the RSV-specific serum antibody responses
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 posted12 Aug 2016 (estimated)
- Study startSep 2016 (estimated)
- Primary completion27 Oct 2017
- Study completion27 Oct 2017
Why it stopped: Protocol was withdrawn from IND
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bavarian Nordic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos Fierro, MD, Principal investigator, Johnson County Clin-Trials (JCCT)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864628
- Sponsor's protocol ID
- RSV-MVA-006
- Status last verified
- Aug 2018
- First submitted
- 9 Aug 2016
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Partially Randomized, Partly Placebo Controlled Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant MVA-BN® RSV Vaccine After Intranasal and Intramuscular Administration
- ClinicalTrials.gov ID
- NCT02864628
- Acronym / sponsor ID
- RSV-MVA-006
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- RSV Vaccines, Respiratory Syncytial Virus Vaccines
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Protocol was withdrawn from IND
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bavarian NordicIndustry (pharma, biotech, devices)
- Study start
- Sep 2016 (estimated)
- Primary completion
- 27 Oct 2017 (actual)
- Study completion
- 27 Oct 2017 (actual)
- First posted
- 12 Aug 2016 (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 96 subjects will be recruited into 5 groups. Each subject will receive either two vaccinations with MVA-BN-RSV vaccine or placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: MVA-BN-RSV, Other: Placebo≥55 year old healthy subjects, receiving either 5x10E7 TCID50 MVA-BN-RSV or Placebo intranasal application |
| Group 2 | Experimental | Biological: MVA-BN-RSV, Other: Placebo≥55 year old healthy subjects, receiving either 1x10E8 TCID50 MVA-BN-RSV or Placebo intranasal application |
| Group 3 | Experimental | Biological: MVA-BN-RSV, Other: Placebo≥55 year old healthy subjects, receiving either 5x10E8 TCID50 MVA-BN-RSV or Placebo intranasal application |
| Group 4 | Experimental | Biological: MVA-BN-RSV≥55 year old healthy subjects, receiving 5x10E8 TCID50 MVA-BN-RSV intranasal and intramuscular application |
| Group 5 | Experimental | Biological: MVA-BN-RSV≥55 year old healthy subjects, receiving 5x10E8 TCID50 MVA-BN-RSV intramuscular application |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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-RSVMVA-mBN294B | Biological | Group 1, Group 2, Group 3, Group 4, Group 5 |
| PlaceboTris Buffered Saline | 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).
1 secondary outcome
RSV-specific humoral immune response
Time frame: humoral immune response is measured up to week 34
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- 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.
Carlos Fierro, MD principal investigator
Johnson County Clin-Trials (JCCT)
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.
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 6 inclusion and 9 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: withdrawn, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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). 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 27 Aug 2018.