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Safety and Immunogenicity of Co-administration of Candidate Influenza Vaccine MVA-NP+M1 and Viroflu® Seasonal Influenza Vaccine

Primary Purpose

Influenza

Status

Terminated

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

Viroflu® and MVA-NP+M1

Viroflu® and saline placebo

About this trial

This is an interventional prevention trial for Influenza

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy adults aged 18 years and over
Able and willing (in the Investigator's opinion) to comply with all study requirements
Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
For heterosexual, pre-menopausal females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day of vaccination
Agreement to refrain from blood donation during the course of the study
Provide 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 an investigational influenza vaccine, or any other investigational vaccine likely to impact on interpretation of the trial data.
Receipt of the 2013/14 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 a 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

Sites / Locations

Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Viroflu® and MVA-NP+M1

Viroflu® and saline placebo

Arm Description

1 dose (0.5ml) of Viroflu® and 1 dose of 1.5 x10^8 pfu MVA-NP+M1 intramuscularly into the vastus lateralis muscle on day 0. The vaccines will be given side by side, with MVA NP+M1 being given immediately after the seasonal influenza vaccine.

1 dose (0.5ml) of Viroflu® and 1 dose of a 0.9% saline placebo injected intramuscularly into the vastus lateralis muscle on day 0. The placebo will be administered immediately after the seasonal influenza vaccine.

Outcomes

Primary Outcome Measures

Cellular immune response generated by co-administration of MVA-NP+M1 and the Viroflu® seasonal influenza vaccine

Interferon-gamma ELISpot will be used as a marker of cell-mediated immunity.

Humoral immune response generated by co-administration of MVA-NP+M1 and the Viroflu® seasonal influenza vaccine

Humoral response will be measured by HI titre, ELISA, or neutralising antibody assay.

Secondary Outcome Measures

Safety of co-administration of MVA-NP+M1 and the Viroflu® seasonal influenza vaccine

Data pertaining to adverse events will be actively and passively collected; the data will be presented according to frequency, severity and duration of adverse events.

Full Information

NCT ID

NCT02014168

First Posted

November 8, 2013

Last Updated

April 29, 2014

Sponsor

University of Oxford

1. Study Identification

Unique Protocol Identification Number

NCT02014168

Brief Title

Safety and Immunogenicity of Co-administration of Candidate Influenza Vaccine MVA-NP+M1 and Viroflu® Seasonal Influenza Vaccine

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Terminated

Why Stopped

Futility

Study Start Date

January 2014 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Oxford

4. Oversight

Data Monitoring Committee

5. Study Description

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 the Viroflu® seasonal influenza vaccine. All volunteers recruited will be healthy adults aged 18 and over.

Detailed Description

This study is designed to test the safety and effectiveness of a combination of two vaccines for influenza. One of these vaccines will be the seasonal influenza vaccine 'Viroflu' ('Inflexal V'). The second will be an investigational viral vectored vaccine called MVA NP+M1. The rationale for combining these two vaccines is that they work differently and that by combining the two vaccines, stronger and broader immune responses may be produced. The MVA NP+M1 vaccine has been evaluated in five previous clinical trials. In total, over 80 volunteers have received this vaccine. There have been no vaccine related serious adverse events. Higher doses of MVA NP+M1 are more reactogenic, however at the dose to be used in this study the majority of adverse events are mild. 20 volunteers will be recruited in this study. They will all be adults over the age of 18. Volunteers will be assigned to one of two groups. Volunteers in group 1 will receive Viroflu, followed by a dose of MVA NP+M1. Volunteers in group 2 will receive Viroflu followed by a placebo injection (saline). Volunteers will be blinded so that they do not know which group they have been allocated to and will be asked to complete diary cards listing any adverse events after vaccination. Vaccinations will be administered into the thigh as the deltoid muscle is not normally large enough to accept two intramuscular injections. Volunteers will followed up for 6 months in total. Two days after vaccination they will receive a telephone call from one of the clinical team. They will then attend three follow up visits (at weeks 1, 3 and 26). At each visit, volunteers will have blood tests taken and will be questioned about any adverse events they may have experienced.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Viroflu® and MVA-NP+M1

Arm Type

Experimental

Arm Description

Arm Title

Viroflu® and saline placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Viroflu® and MVA-NP+M1

Other Intervention Name(s)

Viroflu®, Viroflu, MVA-NP+M1

Intervention Description

2013-2014 season Viroflu, manufactured by Crucell. Contains 15 microgrammes of haemagglutinin (HA) from an H1N1 subtype influenza A virus, an H3N2 subtype influenza A virus and an influenza B virus per 0.5 ml dose. MVA-NP+M1 manufactured by by IDT Biologika GmbH, Germany. Each vial of MVA-NP+M1 contains 700 microlitres volume at a concentration of 1.3 x108 pfu/ml in 10mM Tris buffer. The dose of MVA-NP+M1 to be used in this study will be 1.5 x108 pfu.

Intervention Type

Biological

Intervention Name(s)

Viroflu® and saline placebo

Other Intervention Name(s)

Viroflu®, Viroflu

Intervention Description

Primary Outcome Measure Information:

Title

Cellular immune response generated by co-administration of MVA-NP+M1 and the Viroflu® seasonal influenza vaccine

Description

Interferon-gamma ELISpot will be used as a marker of cell-mediated immunity.

Time Frame

26 weeks

Title

Humoral immune response generated by co-administration of MVA-NP+M1 and the Viroflu® seasonal influenza vaccine

Description

Humoral response will be measured by HI titre, ELISA, or neutralising antibody assay.

Time Frame

26 weeks

Secondary Outcome Measure Information:

Title

Safety of co-administration of MVA-NP+M1 and the Viroflu® seasonal influenza vaccine

Description

Data pertaining to adverse events will be actively and passively collected; the data will be presented according to frequency, severity and duration of adverse events.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy adults aged 18 years and over Able and willing (in the Investigator's opinion) to comply with all study requirements Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner For heterosexual, pre-menopausal females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day of vaccination Agreement to refrain from blood donation during the course of the study Provide 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 an investigational influenza vaccine, or any other investigational vaccine likely to impact on interpretation of the trial data. Receipt of the 2013/14 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 a 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adrian V S Hill, DPhil FRCP

Organizational Affiliation

University of Oxford

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital

City

Oxford

State/Province

Oxfordshire

ZIP/Postal Code

OX3 7LE

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Safety and Immunogenicity of Co-administration of Candidate Influenza Vaccine MVA-NP+M1 and Viroflu® Seasonal Influenza Vaccine

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