E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess if the safety of MVA-NP+M1 vaccination in healthy, adult volunteers. (i.e. safety). |
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E.2.2 | Secondary objectives of the trial |
Secondary: To assess the immune responses in blood generated after vaccination with MVA-NP+M1 'flu vaccine in those volunteers vaccinated (i.e. immunogenicity).
Tertiary: To assess the effect that vaccination has on the amount of virus shed from the volunteers' nose after 'flu challenge. This will compare virus shedding in those who have and those who have not (controls) been vaccinated prior to challenge(i.e. efficacy).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion: 1. Male or females aged 18 - 45 years 2. In general good health determined by a screening evaluation (medical history, physical examination, vital signs electrocardiogram (ECG) and clinical safety laboratory tests). ECG will be performed at entry into quarantine rather than at screening visit. 3. Females should fulfill the following criteria: (i) not pregnant or breastfeeding for the duration of the study and (ii) agree to use a reliable form of contraception for the duration of the study if sexually active 4. Negative HBsAg, HIV, and HCV antibody screen 5. Negative class A drugs of abuse screen 6. Have not been vaccinated for Influenza virus in the current season or had a known influenza virus infection in the current season 7. Give written informed consent to participate 8. Willingness to remain in isolation during the challenge phase of the study and to comply with all study requirements 9. Willing and able to communicate with the Investigator and understand the requirements of the study. |
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E.4 | Principal exclusion criteria |
Exclusion: 1. Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use of an IMP during the study period 2. Prior receipt of a recombinant MVA vaccine 3. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate 4. 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 and topical steroids are allowed) 5. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products 6. Any history of anaphylaxis in reaction to vaccination 7. History of current cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) 8. History of serious current psychiatric condition 9. Any other chronic illness requiring hospital specialist supervision 10. Suspected or known current injecting drug or alcohol abuse (as defined by an alcohol intake of greater than 42 units every week) 11.Any other significant disease, disorder or finding, which, in the opinion of the Investigators, may either put the volunteer at risk because of participation in the study, or may influence the result of the study, or the volunteer’s ability to participate in the study. 12. Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis (see Table 3 of protocol). 13. Venous access inadequate for phlebotomy demands of the study 14. Clinically significant abnormality on ECG 15. History since age 13 of asthma of any aetiology 16. Smokers who are unwilling or unable to desist for the duration of the inpatient challenge component of the study 17. Any anatomic or neurological abnormality impairing the gag reflex or associated with a risk of aspiration 18. Presence of febrile illness or symptoms of upper respiratory tract infection on the day of vaccination (vaccination would be deferred) 19. Presence of febrile illness or symptoms suggestive of influenza between admission for influenza challenge and administration of the challenge inoculum 20. History or evidence of a physician diagnosed chronic or recurrent inflammatory skin disease (e.g. psoriasis, eczema, atopic dermatitis, hypersensitivity) in the past 5 years requiring management by a dermatologist 21. Donation of blood or blood products within 7 days before study entry or at any time during the study 22. Donation of plasma within 7 days of study entry 23. Anti-'flu antibody titre of greater than 10
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Objective To assess the safety of a new influenza vaccine, MVA-NP+M1, when administered as a single dose to healthy volunteers. Secondary Objective To assess the cellular immune response generated by a new influenza vaccine MVA NP+M1 when administered as a single dose to healthy adults Tertiary Objective To assess efficacy of the vaccine by measuring viral shedding from nasal washings post Influenza challenge in adults vaccinated and non-vaccinated with MVA-NP+M1.
These are measured by: Safety profile, ex vivo ELISpot measurements, viral shedding measurements. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
vaccinated versus non-vaccinated |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |