Status:
COMPLETED
A Study to Assess the Safety and Efficacy of a New Influenza Candidate Vaccine MVA-NP+M1 In Healthy Adults
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Wellcome Trust
Conditions:
Influenza
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief Summary
This is a Phase IIa open label, non placebo controlled, non-randomised controlled challenge study. The primary objective of this study is to assess the safety of a new influenza vaccine, MVA-NP+M1, wh...
Detailed Description
Antibodies against the external proteins of influenza can prevent the virus from infecting cells and either prevent infection or limit the spread of infection. However the surface proteins are highly ...
Eligibility Criteria
Inclusion
- Male or females aged 18 - 45 years
- HI titre of less than 10
- In general good health determined by a screening evaluation (medical history, physical examination, vital signs electrocardiogram (ECG) and clinical safety laboratory tests). ECG and spirometry will be performed at entry into quarantine rather than at screening visit
- Females should fulfil 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
- Negative HBsAg, HIV and HCV antibody screen
- Negative class A drugs of abuse screen
- Have not been vaccinated for Influenza virus in the current season or had a known influenza virus infection in the current season
- Give written informed consent to participate
- Willingness to remain in isolation during the challenge phase of the study and to comply with all study requirements
- Willing and able to communicate with the Investigator and understand the requirements of the study
Exclusion
- 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
- Prior receipt of a recombinant MVA vaccine (vaccinees only)
- Administration of immunoglobulins and/or any blood products within the three months preceding date of enrolment.
- 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
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products. Any allergy to eggs or egg products
- Any history of anaphylaxis in reaction to vaccination
- Current cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- Serious current psychiatric condition
- Any other chronic illness requiring hospital specialist supervision
- Suspected or known current injecting drug or alcohol abuse (as defined by an alcohol intake of greater than 42 units every week)
- 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.
- Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis (see Table 1. Values outside the stated limits of Table 1 need written comment by a physician if considered clinically insignificant).
- Venous access inadequate for phlebotomy demands of the study
- Clinically significant abnormality on ECG
- History since age 13 of asthma of any aetiology
- Smokers who are unwilling or unable to desist for the duration of the inpatient challenge component of the study
- Any anatomic or neurologic abnormality impairing the gag reflex or associated with a risk of aspiration
- Presence of febrile illness or symptoms of upper respiratory tract infection on the day of vaccination (vaccination would be deferred)
- Presence of febrile illness or symptoms suggestive of influenza between admission for influenza challenge and administration of the challenge inoculum
- Use of inhaled, topical or systemic steroids in the six months preceding date of enrolment other than occasional use of cutaneous steroid if considered clinically irrelevant to the study by the Investigator..
- Donation of blood or blood products within 7 days before study entry or at any time during the study
- Donation of plasma within 7 days of study entry
- Anti-'flu antibody titre of 10 or greater
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00993083
Start Date
June 1 2009
End Date
March 1 2010
Last Update
August 11 2011
Active Locations (2)
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1
Wellcome Trust Clinical Research Facility, University of Southampton
Southampton, Hampshire, United Kingdom, SO16 6YD
2
Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford, Churchill Hospital
Oxford, Oxfordshire, United Kingdom, OX3 7LJ