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

NCT ID: NCT01465035

Last Updated: 2012-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-11-30

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

TIV and MVA-NP+M1

Co-administration group

1 dose of seasonal influenza vaccine (TIV) and 1 dose of 1.5 x108pfu MVA-NP+M1

Group Type: EXPERIMENTAL

TIV and MVA-NP+M1

Intervention Type: BIOLOGICAL

1.5 x 108 pfu MVA-NP+M1, intramuscular injection into the thigh. Inactivated Influenza Vaccine (Split Virion) 0.5ml (containing 15 micrograms of haemagglutinin, intramuscular injection into the thigh

Saline placebo and seasonal influenza vaccine TIV

Control group

1 dose of seasonal influenza vaccine (TIV) and 1 dose of a saline placebo

Group Type: PLACEBO_COMPARATOR

Saline placebo and seasonal influenza vaccine TIV

Intervention Type: BIOLOGICAL

Saline placebo, intramuscular injection into the thigh. Inactivated Influenza Vaccine (Split Virion) 0.5ml (containing 15 micrograms of haemagglutinin, intramuscular injection into the thigh

Interventions

TIV and MVA-NP+M1

1.5 x 108 pfu MVA-NP+M1, intramuscular injection into the thigh. Inactivated Influenza Vaccine (Split Virion) 0.5ml (containing 15 micrograms of haemagglutinin, intramuscular injection into the thigh

Intervention Type: BIOLOGICAL

Saline placebo and seasonal influenza vaccine TIV

Saline placebo, intramuscular injection into the thigh. Inactivated Influenza Vaccine (Split Virion) 0.5ml (containing 15 micrograms of haemagglutinin, intramuscular injection into the thigh

Intervention Type: BIOLOGICAL

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)
• 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrian VS Hill, DPhil FRCP

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital

Oxford, , United Kingdom

Countries

United Kingdom

Other Identifiers

Flu003

Identifier Type: -

Identifier Source: org_study_id