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.
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Human Volunteers
- Sponsor
- Barinthus Biotherapeutics
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Measure the occurrence of adverse events following intramuscular injection of MVA-NP+M1
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Measure the occurrence of adverse events following intramuscular injection of MVA-NP+M1
Time Frame: 28 days post vaccination
Occurrence and severity of unsolicited adverse events for 28 days following the vaccination using a diary card.
Assessment of safety laboratory assessments following intramuscular injection of MVA-NP+M1
Time Frame: 28 days post vaccination
Review of changes in safety laboratory measures from baseline visit to Day 2, Day 7, Day 21 and Day 28 visits
Measure of systemic reactogenicity following intramuscular injection of MVA-NP+M1
Time Frame: 7 days post vaccination
Occurrence and severity rating of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination using a diary card.
Measure of local reactogenicity following intramuscular injection of MVA-NP+M1
Time Frame: 7 days post vaccination
Occurrence and severity of solicited local reactogenicity signs and symptoms for 7 days following vaccination using a diary card.
Serious Adverse Events that occur during the study
Time Frame: 28 days post vaccination
Review of causality and relationship to MVA-NP+M1 for any serious adverse events during the whole study duration