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

Human Volunteers Clinical Trial

Official title:

A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Influenza Vaccine MVA-NP+M1, Manufactured on the AGE1.CR.pIX Novel Avian Cell Line, in Healthy Adult Volunteers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03277456
• Other study ID #: FLU008
• Status: Completed
• Phase: Early Phase 1
• First received: September 1, 2017
• Last updated: November 10, 2017
• Start date: September 18, 2017
• Est. completion date: November 2, 2017

Study information

• Verified date: November 2017
• Source: Vaccitech Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 2, 2017
• Est. primary completion date: November 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Human Volunteers

Intervention

Biological:
• MVA-NP+M1
Intramuscular injection of novel vaccine

Locations

Country	Name	City	State
United Kingdom	Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)	Oxford	Oxfordshire

Sponsors (2)

Lead Sponsor	Collaborator
Vaccitech Limited	University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of local reactogenicity following intramuscular injection of MVA-NP+M1	Occurrence and severity of solicited local reactogenicity signs and symptoms for 7 days following vaccination using a diary card.	7 days post vaccination
Primary	Measure of systemic reactogenicity following intramuscular injection of MVA-NP+M1	Occurrence and severity rating of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination using a diary card.	7 days post vaccination
Primary	Measure the occurrence of adverse events following intramuscular injection of MVA-NP+M1	Occurrence and severity of unsolicited adverse events for 28 days following the vaccination using a diary card.	28 days post vaccination
Primary	Assessment of safety laboratory assessments following intramuscular injection of MVA-NP+M1	Review of changes in safety laboratory measures from baseline visit to Day 2, Day 7, Day 21 and Day 28 visits	28 days post vaccination
Primary	Serious Adverse Events that occur during the study	Review of causality and relationship to MVA-NP+M1 for any serious adverse events during the whole study duration	28 days post vaccination