InfluenzaPhase 1NCT02014168
Safety and Immunogenicity of Co-administration of Candidate Influenza Vaccine MVA-NP+M1 and Viroflu® Seasonal Influenza Vaccine
A Phase 1 study testing Viroflu® and MVA-NP+M1 in people with Influenza, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This is a single blinded placebo controlled phase I study, to assess the safety and immunogenicity of co-administration of the candidate influenza vaccine MVA-NP+M1 with the Viroflu® seasonal influenza vaccine. All volunteers recruited will be healthy adults aged 18 and over. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Viroflu® and MVA-NP+M1
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Apr 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults aged 18 years and over
- Able and willing (in the Investigator's opinion) to comply with all study requirements
- Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
- For heterosexual, pre-menopausal females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day of vaccination
- Agreement to refrain from blood donation during the course of the study
- Provide written informed consent
Who cannot join
- Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
- Prior receipt of an investigational influenza vaccine, or any other investigational vaccine likely to impact on interpretation of the trial data.
- Receipt of the 2013/14 seasonal influenza vaccine prior to entering the study.
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled/topical steroids are allowed)
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
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- Any history of anaphylaxis in reaction to vaccination
- Recent treatment for cancer (except basal cell carcinoma and cervical carcinoma in situ)
- History of a serious psychiatric condition
- Suspected or known current injecting drug or alcohol abuse (as defined by an alcohol intake of greater than 42 units every week)
- Seropositive for hepatitis B surface (HBsAg) or hepatitis C virus (antibodies to HCV) For pre-menopausal females, pregnancy, lactation or willingness/intention to become pregnant during the study
- Any other significant disease, disorder or finding (including blood test results), which, in the opinion of the Investigators, would either put the volunteer at risk because of participation in the study, or may influence the result of the study.
- No response / confirmation from GP regarding previous medical history
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
Oxford, Oxfordshire, OX3 7LE
About this study
Official title: A Phase I Study to Determine the Safety and Immunogenicity of Co-administration of the Candidate Influenza Vaccine MVA-NP+M1 and the Viroflu® Seasonal Influenza Vaccine
This is a single blinded placebo controlled phase I study, to assess the safety and immunogenicity of co-administration of the candidate influenza vaccine MVA-NP+M1 with the Viroflu® seasonal influenza vaccine. All volunteers recruited will be healthy adults aged 18 and over.
Read the detailed description
This study is designed to test the safety and effectiveness of a combination of two vaccines for influenza. One of these vaccines will be the seasonal influenza vaccine 'Viroflu' ('Inflexal V'). The second will be an investigational viral vectored vaccine called MVA NP+M1. The rationale for combining these two vaccines is that they work differently and that by combining the two vaccines, stronger and broader immune responses may be produced.
The MVA NP+M1 vaccine has been evaluated in five previous clinical trials. In total, over 80 volunteers have received this vaccine. There have been no vaccine related serious adverse events. Higher doses of MVA NP+M1 are more reactogenic, however at the dose to be used in this study the majority of adverse events are mild.
20 volunteers will be recruited in this study. They will all be adults over the age of 18. Volunteers will be assigned to one of two groups. Volunteers in group 1 will receive Viroflu, followed by a dose of MVA NP+M1. Volunteers in group 2 will receive Viroflu followed by a placebo injection (saline). Volunteers will be blinded so that they do not know which group they have been allocated to and will be asked to complete diary cards listing any adverse events after vaccination.
Vaccinations will be administered into the thigh as the deltoid muscle is not normally large enough to accept two intramuscular injections.
Volunteers will followed up for 6 months in total. Two days after vaccination they will receive a telephone call from one of the clinical team. They will then attend three follow up visits (at weeks 1, 3 and 26). At each visit, volunteers will have blood tests taken and will be questioned about any adverse events they may have experienced.
- Conditions
- Influenza
- Being tested
- Viroflu® and MVA-NP+M1, Viroflu® and saline placebo
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viroflu® and MVA-NP+M1Biological
Also called Viroflu®, Viroflu, MVA-NP+M1
2013-2014 season Viroflu, manufactured by Crucell. Contains 15 microgrammes of haemagglutinin (HA) from an H1N1 subtype influenza A virus, an H3N2 subtype influenza A virus and an influenza B virus per 0.5 ml dose.
MVA-NP+M1 manufactured by by IDT Biologika GmbH, Germany. Each vial of MVA-NP+M1 contains 700 microlitres volume at a concentration of 1.3 x108 pfu/ml in 10mM Tris buffer. The dose of MVA-NP+M1 to be used in this study will be 1.5 x108 pfu.
Viroflu® and saline placeboBiological
Also called Viroflu®, Viroflu
2013-2014 season Viroflu, manufactured by Crucell. Contains 15 microgrammes of haemagglutinin (HA) from an H1N1 subtype influenza A virus, an H3N2 subtype influenza A virus and an influenza B virus per 0.5 ml dose.
0.9% saline placebo.
| Study group | Role | What they receive |
|---|---|---|
| Viroflu® and MVA-NP+M1 | Experimental | 1 dose (0.5ml) of Viroflu® and 1 dose of 1.5 x10^8 pfu MVA-NP+M1 intramuscularly into the vastus lateralis muscle on day 0. The vaccines will be given side by side, with MVA NP+M1 being given immediately after the seasonal influenza vaccine. Receives: Biological: Viroflu® and MVA-NP+M1 |
| Viroflu® and saline placebo | Placebo comparator | 1 dose (0.5ml) of Viroflu® and 1 dose of a 0.9% saline placebo injected intramuscularly into the vastus lateralis muscle on day 0. The placebo will be administered immediately after the seasonal influenza vaccine. Receives: Biological: Viroflu® and saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cellular immune response generated by co-administration of MVA-NP+M1 and the Viroflu® seasonal influenza vaccine
Interferon-gamma ELISpot will be used as a marker of cell-mediated immunity.
Measured: 26 weeks
Humoral immune response generated by co-administration of MVA-NP+M1 and the Viroflu® seasonal influenza vaccine
Humoral response will be measured by HI titre, ELISA, or neutralising antibody assay.
Measured: 26 weeks
Secondary outcomes (1)
Safety of co-administration of MVA-NP+M1 and the Viroflu® seasonal influenza vaccine
Data pertaining to adverse events will be actively and passively collected; the data will be presented according to frequency, severity and duration of adverse events.
Measured: Participants will be followed for the duration of the study, an expected average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: Futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrian V S Hill, DPhil FRCP, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014168
- Sponsor's protocol ID
- FLU006
- Other IDs
- 2013-003569-32
- Status last verified
- Apr 2014
- First submitted
- 8 Nov 2013
- Last updated
- 30 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Determine the Safety and Immunogenicity of Co-administration of the Candidate Influenza Vaccine MVA-NP+M1 and the Viroflu® Seasonal Influenza Vaccine
- ClinicalTrials.gov ID
- NCT02014168
- Acronym / sponsor ID
- FLU006
- Conditions
- Influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 18 Dec 2013 (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.
This is a single blinded placebo controlled phase I study, to assess the safety and immunogenicity of co-administration of the candidate influenza vaccine MVA-NP+M1 with the Viroflu® seasonal influenza vaccine. All volunteers recruited will be healthy adults aged 18 and over.
Detailed description
This study is designed to test the safety and effectiveness of a combination of two vaccines for influenza. One of these vaccines will be the seasonal influenza vaccine 'Viroflu' ('Inflexal V'). The second will be an investigational viral vectored vaccine called MVA NP+M1. The rationale for combining these two vaccines is that they work differently and that by combining the two vaccines, stronger and broader immune responses may be produced.
The MVA NP+M1 vaccine has been evaluated in five previous clinical trials. In total, over 80 volunteers have received this vaccine. There have been no vaccine related serious adverse events. Higher doses of MVA NP+M1 are more reactogenic, however at the dose to be used in this study the majority of adverse events are mild.
20 volunteers will be recruited in this study. They will all be adults over the age of 18. Volunteers will be assigned to one of two groups. Volunteers in group 1 will receive Viroflu, followed by a dose of MVA NP+M1. Volunteers in group 2 will receive Viroflu followed by a placebo injection (saline). Volunteers will be blinded so that they do not know which group they have been allocated to and will be asked to complete diary cards listing any adverse events after vaccination.
Vaccinations will be administered into the thigh as the deltoid muscle is not normally large enough to accept two intramuscular injections.
Volunteers will followed up for 6 months in total. Two days after vaccination they will receive a telephone call from one of the clinical team. They will then attend three follow up visits (at weeks 1, 3 and 26). At each visit, volunteers will have blood tests taken and will be questioned about any adverse events they may have experienced.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Viroflu® and MVA-NP+M1 | Experimental | Biological: Viroflu® and MVA-NP+M11 dose (0.5ml) of Viroflu® and 1 dose of 1.5 x10^8 pfu MVA-NP+M1 intramuscularly into the vastus lateralis muscle on day 0. The vaccines will be given side by side, with MVA NP+M1 being given immediately after the seasonal influenza vaccine. |
| Viroflu® and saline placebo | Placebo comparator | Biological: Viroflu® and saline placebo1 dose (0.5ml) of Viroflu® and 1 dose of a 0.9% saline placebo injected intramuscularly into the vastus lateralis muscle on day 0. The placebo will be administered immediately after the seasonal influenza vaccine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy adults aged 18 years and over
- Able and willing (in the Investigator's opinion) to comply with all study requirements
- Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
- For heterosexual, pre-menopausal females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day of vaccination
- Agreement to refrain from blood donation during the course of the study
Key exclusion criteria (13 listed)
- Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
- Prior receipt of an investigational influenza vaccine, or any other investigational vaccine likely to impact on interpretation of the trial data.
- Receipt of the 2013/14 seasonal influenza vaccine prior to entering the study.
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled/topical steroids are allowed)
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 |
|---|---|---|
| Viroflu® and MVA-NP+M1Also: Viroflu®, Viroflu, MVA-NP+M12013-2014 season Viroflu, manufactured by Crucell. Contains 15 microgrammes of haemagglutinin (HA) from an H1N1 subtype influenza A virus, an H3N2 subtype influenza A virus and an influenza B virus per 0.5 ml dose. MVA-NP+M1 manufactured by by IDT Biologika GmbH, Germany. Each vial of MVA-NP+M1 contains 700 microlitres volume at a concentration of 1.3 x108 pfu/ml in 10mM Tris buffer. The dose of MVA-NP+M1 to be used in this study will be 1.5 x108 pfu. | Biological | Viroflu® and MVA-NP+M1 |
| Viroflu® and saline placeboAlso: Viroflu®, Viroflu2013-2014 season Viroflu, manufactured by Crucell. Contains 15 microgrammes of haemagglutinin (HA) from an H1N1 subtype influenza A virus, an H3N2 subtype influenza A virus and an influenza B virus per 0.5 ml dose. 0.9% saline placebo. | Biological | Viroflu® and saline placebo |
Primary outcome
Cellular immune response generated by co-administration of MVA-NP+M1 and the Viroflu® seasonal influenza vaccine
Time frame: 26 weeks
Interferon-gamma ELISpot will be used as a marker of cell-mediated immunity.
Humoral immune response generated by co-administration of MVA-NP+M1 and the Viroflu® seasonal influenza vaccine
Time frame: 26 weeks
Humoral response will be measured by HI titre, ELISA, or neutralising antibody assay.
1 secondary outcome
Safety of co-administration of MVA-NP+M1 and the Viroflu® seasonal influenza vaccine
Time frame: Participants will be followed for the duration of the study, an expected average of 6 months
Results and safety
The study was stopped early (reason given: Futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2014.
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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.
Adrian V S Hill, DPhil FRCP principal investigator
University of Oxford
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 Viroflu® and MVA-NP+M1 in people with Influenza, run by University of Oxford at 1 site in United Kingdom.
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 13 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: stopped early, as of the sponsor's last update on 30 Apr 2014. 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 Kingdom. 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. Some participants in this study may receive a placebo. 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 stopped early (reason given: Futility). Results are not available in the source record.
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?
Cellular immune response generated by co-administration of MVA-NP+M1 and the Viroflu® seasonal influenza vaccine (time frame: 26 weeks). The study lists 2 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 30 Apr 2014.