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

Purpose

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.

Condition	Intervention	Phase
Influenza	Biological: TIV and MVA-NP+M1 Biological: Saline placebo and seasonal influenza vaccine TIV	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by University of Oxford:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
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 [ Time Frame: Participants will be followed for the duration of the study, an expected average of 6 months ] [ Designated as safety issue: No ]
To assess immune response generated by co-administration of MVA-NP+M1 by interferon-gamma ELISpot and ELISA.

Enrollment:	24
Study Start Date:	October 2011
Study Completion Date:	November 2012
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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	Biological: 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
Placebo Comparator: Saline placebo and seasonal influenza vaccine TIV Control group 1 dose of seasonal influenza vaccine (TIV) and 1 dose of a saline placebo	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

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465035

Locations

United Kingdom
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
Oxford, United Kingdom, OX3 7LJ

Sponsors and Collaborators

University of Oxford

Investigators

Principal Investigator:

Adrian VS Hill, DPhil FRCP

University of Oxford

More Information

No publications provided

Responsible Party:	University of Oxford
ClinicalTrials.gov Identifier:	NCT01465035 History of Changes
Other Study ID Numbers:	Flu003
Study First Received:	October 21, 2011
Last Updated:	November 28, 2012
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013