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

University of Oxford1 site in 1 country24 target enrollmentOctober 2011

ConditionsInfluenza

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Influenza
Sponsor: University of Oxford
Enrollment: 24
Locations: 1
Primary Endpoint: Safety of co-administration of MVA-NP+M1 and seasonal influenza vaccine.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

November 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Oxford

Responsible Party

Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Safety of co-administration of MVA-NP+M1 and seasonal influenza vaccine.

Time Frame: Participants will be followed for the duration of the study, an expected average of 6 months

The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events.

Secondary Outcomes

Immune response generated by co-administration of MVA-NP+M1 and seasonal influenza vaccine(Participants will be followed for the duration of the study, an expected average of 6 months)