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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
TIV and MVA-NP+M1
Saline placebo and seasonal influenza vaccine TIV
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts 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

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

TIV and MVA-NP+M1

Saline placebo and seasonal influenza vaccine TIV

Arm Description

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

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

Outcomes

Primary Outcome Measures

Safety of co-administration of MVA-NP+M1 and seasonal influenza vaccine.
The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events.

Secondary Outcome Measures

Immune response generated by co-administration of MVA-NP+M1 and seasonal influenza vaccine
To assess immune response generated by co-administration of MVA-NP+M1 by interferon-gamma ELISpot and ELISA.

Full Information

First Posted
October 21, 2011
Last Updated
November 28, 2012
Sponsor
University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT01465035
Brief Title
A Study to Determine the Safety and Immunogenicity of Co-administration of the Candidate Influenza Vaccine MVA-NP+M1 and 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 Seasonal Influenza Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford

4. Oversight

Data Monitoring Committee
Yes

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 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.

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
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TIV and MVA-NP+M1
Arm Type
Experimental
Arm Description
Co-administration group 1 dose of seasonal influenza vaccine (TIV) and 1 dose of 1.5 x108pfu MVA-NP+M1
Arm Title
Saline placebo and seasonal influenza vaccine TIV
Arm Type
Placebo Comparator
Arm Description
Control group 1 dose of seasonal influenza vaccine (TIV) and 1 dose of a saline placebo
Intervention Type
Biological
Intervention Name(s)
TIV and MVA-NP+M1
Intervention Description
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
Intervention Name(s)
Saline placebo and seasonal influenza vaccine TIV
Intervention Description
Saline placebo, intramuscular injection into the thigh. Inactivated Influenza Vaccine (Split Virion) 0.5ml (containing 15 micrograms of haemagglutinin, intramuscular injection into the thigh
Primary Outcome Measure Information:
Title
Safety of co-administration of MVA-NP+M1 and seasonal influenza vaccine.
Description
The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events.
Time Frame
Participants will be followed for the duration of the study, an expected average of 6 months
Secondary Outcome Measure Information:
Title
Immune response generated by co-administration of MVA-NP+M1 and seasonal influenza vaccine
Description
To assess immune response generated by co-administration of MVA-NP+M1 by interferon-gamma ELISpot and ELISA.
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
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian VS 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
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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