DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: University of Oxford
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: TIV and MVA-NP+M1 (Biological); Saline placebo and seasonal influenza vaccine TIV (Biological)

Phase: Phase 1

Status: Completed

Sponsored by: University of Oxford

Official(s) and/or principal investigator(s):
Adrian VS Hill, DPhil FRCP, Principal Investigator, Affiliation: University of Oxford


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.

Clinical Details

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

Primary outcome: Safety of co-administration of MVA-NP+M1 and seasonal influenza vaccine.

Secondary outcome: Immune response generated by co-administration of MVA-NP+M1 and seasonal influenza vaccine


Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.


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


- 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


- 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

Locations and Contacts

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

Starting date: October 2011
Last updated: November 28, 2012

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017