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NCT Number: NCT01465035

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

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital

Oxford, OX3 7LJ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TIV and MVA-NP+M1

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

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

Primary outcomes

  1. 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

  1. Immune response generated by 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

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

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 4, 2011
Registry last updated
Nov 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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