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

NCT02014168 | Terminated Phase 1

• 2 other identifiers: FLU0062013-003569-32
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (2)

• 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.

  26 weeks

• 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.

  26 weeks

Secondary Outcomes (1)

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

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

Study Arms (2)

Viroflu® and MVA-NP+M1

EXPERIMENTAL

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.

Biological: Viroflu® and MVA-NP+M1

Viroflu® and saline placebo

PLACEBO COMPARATOR

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.

Biological: Viroflu® and saline placebo

Interventions

Viroflu® and MVA-NP+M1 BIOLOGICAL

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.

Also known as: Viroflu®, Viroflu, MVA-NP+M1

Viroflu® and MVA-NP+M1

Viroflu® and saline placebo BIOLOGICAL

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. 0.9% saline placebo.

Also known as: Viroflu®, Viroflu

Viroflu® and saline placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Adrian V S Hill, DPhil FRCP

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2013
• First Posted: December 18, 2013
• Study Start: January 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 30, 2014

Record last verified: 2014-04

Locations

GB (1)