Influenza Clinical Trial
Official title:
A Phase I Study to Assess the Safety and Immunogenicity of a New Influenza Vaccine Candidate MVA-NP+M1 in Healthy Adults
This is an open label phase I study, to assess the safety of a novel influenza vaccine, MVA-NP+M1. All volunteers recruited will be healthy. Twelve volunteers will be administered with a single dose of 5 x 10^7 pfu of MVA-NP+M1 via the Intradermal (ID) route (group 1). Sixteen volunteers will receive Intramuscular (IM) MVA-NP+M1. The first 8 volunteers will be administered a single dose of 5 x 10^7 pfu of MVA-NP+M1 followed by a further eight receiving 2.5 x 10^8 pfu of MVA-NP+M1 (group 2). The 3rd group will be split into 3 groups of 10 volunteers in the age ranges 50-59, 60-69 and 70 and above and administered intramuscularly with a single dose of 1.5 x 10^8 pfu of MVA-NP+M1. Safety data will be collected. The secondary aim of this study will be to assess the cellular immune responses generated by each dose.
Status | Completed |
Enrollment | 58 |
Est. completion date | November 2012 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Healthy adult aged 18 or over, no upper age limit - Resident in or near Oxford for the duration of the vaccination study - Able and willing (in the Investigators' opinions) to comply with all study requirements - Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner - For females, a negative pregnancy test on the day of vaccination and agreement to practice effective contraception for the duration of the study. - Agreement to refrain from blood donation during the course of the study - Written informed consent Exclusion Criteria: - 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 a recombinant MVA 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 and topical steroids are allowed) - History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products - Any history of anaphylaxis in reaction to vaccination - History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) - History of serious psychiatric condition - Any chronic illness requiring ongoing 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 antigen (HBsAg) - Seropositive for hepatitis C virus (antibodies to HCV) - For females, pregnancy, lactation or willingness/intention to become pregnant during the study - 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, as determined by the investigators. |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United Kingdom | Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford, Churchill Hospital | Oxford | Oxfordshire |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | Wellcome Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the safety of a new influenza vaccine, MVA-NP+M1, when administered to healthy volunteers. | 24 months | Yes | |
Secondary | To assess the cellular immune response generated by a new influenza vaccine, MVA-NP+M1, when administered as a single dose to healthy volunteers. | 24 months | No |
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