Seasonal InfluenzaPhase 1NCT01818362
A Phase I Study of Candidate Influenza Vaccines MVA-NP+M1 and ChAdOx1 NP+M1
A Phase 1 study testing MVA NP+M1 and ChAdOx1 NP+M1 in people with Seasonal Influenza, run by University of Oxford at 3 sites in United Kingdom.
Trial summary
This will be a randomised observational phase 1 study in 48 healthy volunteers aged 18-50. The study is assessing safety and immunogenicity of viral vectored vaccines ChAdOx1 NP+M1 and MVA NP+M1 in heterologous prime-boost regimens. A crossover design will allow comparison of the two vaccines. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Seasonal Influenza
- What is being tested?
- MVA NP+M1 and ChAdOx1 NP+M1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Apr 2013to Nov 2015
- 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
- The volunteer must satisfy all the following criteria to be eligible for the study:
- Healthy adults aged 18 to 50 years
- 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 females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day(s) of vaccination
- Agreement to refrain from blood donation during the course of the study
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- Provide written informed consent
- The volunteer must satisfy all the following criteria to be eligible for the study:
- Healthy adults aged 50 or over, no upper age limit
- 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 women of child bearing potential only, willingness to practice continuous effective contraception (i.e. hormonal contraception, intrauterine device or barrier contraception) during the study and a negative urinary pregnancy test on the day(s) of vaccination
- Agreement to refrain from blood donation during the course of the study
- Provide written informed consent
Who cannot join
- The volunteer may not enter the study if any of the following apply:
- Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
- Previous receipt of any recombinant adenoviral or recombinant MVA vectored vaccine
- 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
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- Any history of anaphylaxis in reaction to vaccination
- History of cancer (except basal cell carcinoma and cervical carcinoma in situ)
- History of serious psychiatric condition
- Any chronic illness requiring on-going or awaiting hospital specialist supervision, other than minor surgical procedures and follow up of surgery over 6 months prior to screening
- 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)
- 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
- The volunteer may not enter the study if any of the following apply:
- Participation in another research study involving an investigational product in the 30 days preceding enrolment, or plans to participate during the study period
- Previous receipt of a vaccine or plans to receive any vaccinations during the study that would interfere with the interpretation of the results of the trial
- 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 including eye drops and nasal spray/intra-articular steroid injections are allowed)
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including eggs or Kathon (a biocide added to body washes, conditioners, liquid soaps, shampoos and wipes as a preservative)
- Any history of anaphylaxis in reaction to vaccination
- History of treatment for cancer within the preceding six months (except basal cell carcinoma and cervical carcinoma in situ)
- History of serious psychiatric condition
- Any chronic illness requiring on-going or awaiting hospital specialist supervision, other than minor surgical procedures and follow up of surgery over 6 months prior to screening
- Suspected or known injecting drug abuse within the last 5 years
- Alcohol abuse (as defined by an alcohol intake of greater than 42 units every week)
- Seropositive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (antibodies to HCV) or HIV
- 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
3 sites in 1 country.
United Kingdom3 sites
Surrey Clinical Research Centre, University of Surrey
Guildford, GU2 7XP
Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxfordshire, OX3 7LE
NIHR Wellcome Trust Clinical Research Facility Southampton
Southampton, SO16 6YD
About this study
Official title: A Phase I Study to Determine the Safety and Immunogenicity of Vaccination Regimens Employing the Candidate Influenza Vaccines MVA-NP+M1 and ChAdOx1 NP+M1
This will be a randomised observational phase 1 study in 48 healthy volunteers aged 18-50. The study is assessing safety and immunogenicity of viral vectored vaccines ChAdOx1 NP+M1 and MVA NP+M1 in heterologous prime-boost regimens. A crossover design will allow comparison of the two vaccines. Volunteers will be divided into 4 groups (n=12 in each group). Groups will be recruited simultaneously to control for seasonal changes in influenza. This is because at certain times of year there is likely to be a higher naturally acquired T cell response to influenza than at other times due to circulating influenza virus in the community.
The study has been extended to include 2 additional groups (group 5 \& 6), each containing 12 healthy adults aged 50 years or above. Group 5 will receive ChAdOx 1 NP+M1 on day 0, and group 6 will receive this with an additional boost of MVA-NP+M1 8 weeks later.
- Conditions
- Seasonal Influenza
- Being tested
- MVA NP+M1, ChAdOx1 NP+M1
- Keywords
- Influenza, T cells
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVA NP+M1Biological
MVA NP+M1 1.5 x 10⁸pfu intramuscularly.
ChAdOx1 NP+M1Biological
ChAdOx1 NP+M1 2.5 x 10¹⁰vp intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| Group 2 | Experimental | ChAdOx1 NP+M1 2.5 x 10¹⁰vp followed by MVA NP+M1 1.5 x 10⁸pfu 52 weeks later. Receives: Biological: MVA NP+M1; Biological: ChAdOx1 NP+M1 |
| Group 3 | Experimental | MVA NP+M1 1.5 x 10⁸pfu followed by ChAdOx1 NP+M1 2.5 x 10¹⁰vp 8 weeks later. Receives: Biological: MVA NP+M1; Biological: ChAdOx1 NP+M1 |
| Group 4 | Experimental | MVA NP+M1 1.5 x 10⁸pfu followed by ChAdOx1 NP+M1 2.5 x 10¹⁰vp 52 weeks later. Receives: Biological: MVA NP+M1; Biological: ChAdOx1 NP+M1 |
| Group 1 | Experimental | ChAdOx1 NP+M1 2.5 x 10¹⁰vp followed by MVA NP+M1 1.5 x 10⁸pfu 8 weeks later. Receives: Biological: MVA NP+M1; Biological: ChAdOx1 NP+M1 |
| Group 5 | Experimental | ChAdOx1 NP+M1 2.5 x 10¹⁰vp Receives: Biological: MVA NP+M1 |
| Group 6 | Experimental | ChAdOx1 NP+M1 2.5 x 10¹⁰vp followed by MVA NP+M1 1.5 x 10⁸pfu 8 weeks later. Receives: Biological: MVA NP+M1; Biological: ChAdOx1 NP+M1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of prime/boost vaccination regimens employing MVA-NP+M1 and ChAdOx1 NP+M1.
Safety will be assessed by the nature, frequency, severity, seriousness and duration of adverse events arising during the study combined with analysis of hematology and biochemistry lab tests for abnormalities.
Measured: Up to 78 weeks post first vaccination.
Secondary outcomes (1)
To assess the cellular immune response generated by prime/boost vaccination regimens employing MVA-NP+M1 and ChAdOx1 NP+M1.
The secondary outcomes of peak immune response after first vaccination and peak immune response after second vaccination will be analysed by calculating the area under the curve of the immune response (IFN-γ SFC/ million PBMCs) for each volunteer from baseline to week 78. The mean area under the curve in the 4 groups will then be compared using an analysis of variance, or in the case of skewed data a Kruskal Wallis test. Further pairwise comparisons will be made if a significant difference is found between groups.
Measured: 78 weeks after first vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrian V S Hill, MD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818362
- Sponsor's protocol ID
- FLU005
- Status last verified
- Dec 2015
- First submitted
- 18 Mar 2013
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. 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 Vaccination Regimens Employing the Candidate Influenza Vaccines MVA-NP+M1 and ChAdOx1 NP+M1
- ClinicalTrials.gov ID
- NCT01818362
- Acronym / sponsor ID
- FLU005
- Conditions
- Seasonal Influenza
- Keywords
- Influenza, T cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 26 Mar 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 will be a randomised observational phase 1 study in 48 healthy volunteers aged 18-50. The study is assessing safety and immunogenicity of viral vectored vaccines ChAdOx1 NP+M1 and MVA NP+M1 in heterologous prime-boost regimens. A crossover design will allow comparison of the two vaccines. Volunteers will be divided into 4 groups (n=12 in each group). Groups will be recruited simultaneously to control for seasonal changes in influenza. This is because at certain times of year there is likely to be a higher naturally acquired T cell response to influenza than at other times due to circulating influenza virus in the community.
The study has been extended to include 2 additional groups (group 5 \& 6), each containing 12 healthy adults aged 50 years or above. Group 5 will receive ChAdOx 1 NP+M1 on day 0, and group 6 will receive this with an additional boost of MVA-NP+M1 8 weeks later.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 2 | Experimental | Biological: MVA NP+M1, Biological: ChAdOx1 NP+M1ChAdOx1 NP+M1 2.5 x 10¹⁰vp followed by MVA NP+M1 1.5 x 10⁸pfu 52 weeks later. |
| Group 3 | Experimental | Biological: MVA NP+M1, Biological: ChAdOx1 NP+M1MVA NP+M1 1.5 x 10⁸pfu followed by ChAdOx1 NP+M1 2.5 x 10¹⁰vp 8 weeks later. |
| Group 4 | Experimental | Biological: MVA NP+M1, Biological: ChAdOx1 NP+M1MVA NP+M1 1.5 x 10⁸pfu followed by ChAdOx1 NP+M1 2.5 x 10¹⁰vp 52 weeks later. |
| Group 1 | Experimental | Biological: MVA NP+M1, Biological: ChAdOx1 NP+M1ChAdOx1 NP+M1 2.5 x 10¹⁰vp followed by MVA NP+M1 1.5 x 10⁸pfu 8 weeks later. |
| Group 5 | Experimental | Biological: MVA NP+M1ChAdOx1 NP+M1 2.5 x 10¹⁰vp |
| Group 6 | Experimental | Biological: MVA NP+M1, Biological: ChAdOx1 NP+M1ChAdOx1 NP+M1 2.5 x 10¹⁰vp followed by MVA NP+M1 1.5 x 10⁸pfu 8 weeks later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Healthy adults aged 18 to 50 years
- 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 females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day(s) of vaccination
- Agreement to refrain from blood donation during the course of the study
Key exclusion criteria (31 listed)
- Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
- Previous receipt of any recombinant adenoviral or recombinant MVA vectored vaccine
- 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
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 NP+M1MVA NP+M1 1.5 x 10⁸pfu intramuscularly. | Biological | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
| ChAdOx1 NP+M1ChAdOx1 NP+M1 2.5 x 10¹⁰vp intramuscularly. | Biological | Group 1, Group 2, Group 3, Group 4, Group 6 |
Primary outcome
To assess the safety of prime/boost vaccination regimens employing MVA-NP+M1 and ChAdOx1 NP+M1.
Time frame: Up to 78 weeks post first vaccination.
Safety will be assessed by the nature, frequency, severity, seriousness and duration of adverse events arising during the study combined with analysis of hematology and biochemistry lab tests for abnormalities.
1 secondary outcome
To assess the cellular immune response generated by prime/boost vaccination regimens employing MVA-NP+M1 and ChAdOx1 NP+M1.
Time frame: 78 weeks after first vaccination
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 15 Dec 2015.
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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, MD principal investigator
University of Oxford
3 sites 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 NP+M1 and ChAdOx1 NP+M1 in people with Seasonal Influenza, run by University of Oxford at 3 sites 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 14 inclusion and 31 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 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
To assess the safety of prime/boost vaccination regimens employing MVA-NP+M1 and ChAdOx1 NP+M1. (time frame: Up to 78 weeks post 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 15 Dec 2015.