A phase IIa study to assess the safety and efficacy of a new influenza vaccine candidate MVA-NP+M1 in healthy adults. - A study to assess the safety and efficacy of a new influenza vaccine
- Conditions
- Influenza
- Registration Number
- EUCTR2009-010334-21-GB
- Lead Sponsor
- Oxford University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method