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

NCT ID: NCT03277456

Last Updated: 2017-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-18
• Study Completion Date: 2017-11-02

Brief Summary

This is a first in human, phase I, open label study of the MVA viral vector (produced in the novel immortalised duck retinal cell line AGE1.CR.pIX) expressing the influenza antigens NP and M1 as a fusion protein, in healthy adult volunteers. MVA-NP+M1 will be given alone intramuscularly as a single dose.

There will be 1 study group and a total of 6 volunteers will be enrolled. Staggered enrollment will apply for the first three volunteers within the group.

Conditions

Human Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Single intramuscular injection of MVA-NP+M1 vaccine

MVA-NP+M1, a novel vaccine will be administered intramuscular. The total volume given is 0.5ml and the dose given is 1.5E8 pfu. Each volunteer will receive one single injection only over a few seconds.

Group Type: EXPERIMENTAL

MVA-NP+M1

Intervention Type: BIOLOGICAL

Intramuscular injection of novel vaccine

Interventions

MVA-NP+M1

Intramuscular injection of novel vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Healthy adults aged 18-50

2. Able and willing (in the Investigator's opinion) to comply with all study requirements

3. Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner

4. For females only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination (for women of child bearing potential only)

5. Agreement to refrain from blood donation during the course of the study

6. Provide written informed consent

Exclusion Criteria

1. Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period

2. Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data.

3. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate

4. 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 and topical steroids are allowed)

5. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine

6. Any history of anaphylaxis in relation to vaccination

7. Pregnancy, lactation or willingness/intention to become pregnant during the study (for women of child bearing potential only)

8. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)

9. History of serious psychiatric condition likely to affect participation in the study

10. Bleeding disorder (eg. Factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture

11. Any other serious chronic illness requiring hospital specialist supervision

12. Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week

13. Suspected or known injecting drug abuse in the 5 years preceding enrolment

14. Seropositive for hepatitis B surface antigen (HBsAg)

15. Seropositive for hepatitis C virus (antibodies to HCV)

16. Any clinically significant abnormal finding on screening biochemistry and haematology blood tests or urinalysis

17. Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data

18. Inability of the study team to contact the volunteer's GP to confirm medical history and safety to participate

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oxford

OTHER

Sponsor Role: collaborator

Barinthus Biotherapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrian Hill, MD

Role: PRINCIPAL_INVESTIGATOR

Director, The Jenner Institute, Oxford University

Locations

Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)

Oxford, Oxfordshire, United Kingdom

Countries

United Kingdom

Other Identifiers

FLU008

Identifier Type: -

Identifier Source: org_study_id