Skip to main content
OpenTrials
Completed

NCT Number: NCT03277456

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)

Oxford, Oxfordshire, OX3 7LJ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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)
  • Any clinically significant abnormal finding on screening biochemistry and haematology blood tests or urinalysis
  • 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
  • Inability of the study team to contact the volunteer's GP to confirm medical history and safety to participate

Treatment and study plan

MVA-NP+M1

Biological

Intramuscular injection of novel vaccine

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Barinthus Biotherapeutics

Industry

Collaborators

  • University of Oxford

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 11, 2017
Registry last updated
Nov 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.