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

NCT03277456 | Completed Early Phase 1 DMC

• 1 other identifier: FLU008
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Single intramuscular injection of MVA-NP+M1 vaccine

EXPERIMENTAL

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.

Biological: MVA-NP+M1

Interventions

MVA-NP+M1 BIOLOGICAL

Intramuscular injection of novel vaccine

Single intramuscular injection of MVA-NP+M1 vaccine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults aged 18-50
• Able and willing (in the Investigator's opinion) to comply with all study requirements
• Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
• 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)
• Agreement to refrain from blood donation during the course of the study
• Provide written informed consent

You may not qualify if:

• Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
• Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data.
• 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 and topical steroids are allowed)
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
• Any history of anaphylaxis in relation to vaccination
• Pregnancy, lactation or willingness/intention to become pregnant during the study (for women of child bearing potential only)
• History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
• History of serious psychiatric condition likely to affect participation in the study
• Bleeding disorder (eg. Factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
• Any other serious chronic illness requiring hospital specialist supervision
• Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
• Suspected or known injecting drug abuse in the 5 years preceding enrolment
• Seropositive for hepatitis B surface antigen (HBsAg)
• Seropositive for hepatitis C virus (antibodies to HCV)

Sponsors & Collaborators

• Barinthus Biotherapeutics: lead
• University of Oxford: collaborator

Study Sites (1)

Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)

Oxford, Oxfordshire, OX3 7LJ, United Kingdom

Location

Study Officials

• Adrian Hill, MD

  Director, The Jenner Institute, Oxford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2017
• First Posted: September 11, 2017
• Study Start: September 18, 2017
• Primary Completion: November 2, 2017
• Study Completion: November 2, 2017
• Last Updated: November 14, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)