A Study to Determine the Safety and Immunogenicity of Co-administration of the Candidate Influenza Vaccine MVA-NP+M1 and Seasonal Influenza Vaccine

University of Oxford

Status and phase

Completed

Phase 1

Conditions

Influenza

Treatments

Biological: Saline placebo and seasonal influenza vaccine TIV

Biological: TIV and MVA-NP+M1

Study type

Interventional

Funder types

Other

Identifiers

NCT01465035

Flu003

Details and patient eligibility

About

This is a single blinded placebo controlled phase I study, to assess the safety and immunogenicity of co-administration of the candidate influenza vaccine MVA-NP+M1 with seasonal influenza vaccine. All volunteers recruited will be adults aged 50 and over.

The rationale behind co-administration of MVA-NP+M1 with a seasonal influenza vaccine (TIV) is that the immune system will be stimulated to produce both influenza specific T cells and influenza specific antibodies.

Enrollment

24 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Men and women aged 50 or over with 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 who are not post-menopausal, 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

Receipt of MVA or smallpox vaccines in the last 5 years, or receipt of the 2011/12 seasonal influenza vaccine prior to entering the study.
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, e.g. egg products
Any history of anaphylaxis in reaction to vaccination
Recent treatment for cancer (except basal cell carcinoma and cervical carcinoma in situ)
History of serious psychiatric condition
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)
For pre-menopausal females, 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