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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01465035
• Other study ID #: Flu003
• Status: Completed
• Phase: Phase 1
• First received: October 21, 2011
• Last updated: November 28, 2012
• Start date: October 2011
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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
• 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

Locations

Country	Name	City	State
United Kingdom	Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Participants will be followed for the duration of the study, an expected average of 6 months	Yes
Secondary	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.	Participants will be followed for the duration of the study, an expected average of 6 months	No