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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03277456
Recruitment Status : Completed
First Posted : September 11, 2017
Last Update Posted : November 14, 2017
Sponsor:
Collaborator:
University of Oxford
Information provided by (Responsible Party):
Vaccitech Limited

Tracking Information
First Submitted Date  ICMJE September 1, 2017
First Posted Date  ICMJE September 11, 2017
Last Update Posted Date November 14, 2017
Actual Study Start Date  ICMJE September 18, 2017
Actual Primary Completion Date November 2, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2017)
  • 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.
  • 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 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Determine the Safety and Immunogenicity of the Candidate Influenza Vaccine MVA-NP+M1
Official Title  ICMJE 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.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Human Volunteers
Intervention  ICMJE Biological: MVA-NP+M1
Intramuscular injection of novel vaccine
Study Arms  ICMJE Experimental: 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.
Intervention: Biological: MVA-NP+M1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 6, 2017)
6
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2, 2017
Actual Primary Completion Date November 2, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03277456
Other Study ID Numbers  ICMJE FLU008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vaccitech Limited
Study Sponsor  ICMJE Vaccitech Limited
Collaborators  ICMJE University of Oxford
Investigators  ICMJE
Principal Investigator: Adrian Hill, MD Director, The Jenner Institute, Oxford University
PRS Account Vaccitech Limited
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP