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A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Influenza Vaccine ChAdOx1-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: NCT01623518
Recruitment Status : Completed
First Posted : June 20, 2012
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Tracking Information
First Submitted Date  ICMJE June 13, 2012
First Posted Date  ICMJE June 20, 2012
Last Update Posted Date December 2, 2014
Study Start Date  ICMJE June 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2012)
Safety [ Time Frame: 3 weeks ]
Analysis of data on adverse events.
Original Primary Outcome Measures  ICMJE
 (submitted: June 15, 2012)
Safety [ Time Frame: 3 weeks ]
The specific endpoints for safety will be actively and passively collected data on adverse events.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2012)
Reactogenicity [ Time Frame: 3 weeks ]
Immunogenicity endpoints will include interferon-gamma ELISpot as a marker of cell-mediated immunity.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Influenza Vaccine ChAdOx1-NP+M1
Official Title  ICMJE A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Influenza Vaccine ChAdOx1-NP+M1
Brief Summary This is a first in man dose escalation study, to assess the safety and immunogenicity of the candidate influenza vaccine ChAdOx1-NP+M1. All volunteers recruited will be healthy adults aged 18-50. Volunteers will be enrolled and doses will be escalated according to a "3+3" study plan. Up to 24 volunteers will be vaccinated. Following one dose of the vaccine, volunteers will be followed up to assess the side effect profile of the vaccine and to take blood tests. A series of immunology assays will be performed to determine how potent the vaccine is at inducing an immune response.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Influenza
Intervention  ICMJE Biological: ChAdOx1-NP+M1

Dose escalation in a 3+3 study plan;

5 x10^8 vp, 5 x10^9 vp, 2.5 x10^10 vp, 5 x10^10 vp

Study Arms  ICMJE Experimental: ChAdOx1-NP+M1
Intervention: Biological: ChAdOx1-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: December 1, 2014)
15
Original Estimated Enrollment  ICMJE
 (submitted: June 15, 2012)
18
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

The volunteer must satisfy all the following criteria to be eligible for the study:

  • Men and women aged 18-50
  • Resident in or near Oxford for the duration of the vaccination study
  • Able and willing (in the Investigators' opinions) to comply with all study requirements
  • Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
  • Willingness to use effective contraception for 4 weeks from the date of vaccination
  • Agreement to refrain from blood donation for 4 weeks from the date of vaccination
  • Written informed consent

Exclusion Criteria:

The volunteer may not enter the study if any of the following apply:

  • Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
  • Previous receipt of any recombinant adenoviral vectored vaccine
  • Previous receipt of MVA-NP+M1
  • 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/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 reaction to vaccination
  • History of cancer (except basal cell carcinoma and cervical carcinoma in situ)
  • History of serious psychiatric condition
  • Any chronic illness requiring ongoing or awaiting hospital specialist supervision, other than minor surgical procedures and follow up of surgery over 6 months prior to screening.
  • Suspected or known current injecting drug or alcohol abuse (as defined by an alcohol intake of greater than 42 units every week)
  • Seropositive for hepatitis B surface (HBsAg) or hepatitis C virus (antibodies to HCV)
  • Pregnancy, lactation or willingness/intention to become pregnant during the study
  • Any other significant disease, disorder or finding (including blood test results), which, in the opinion of the Investigators, would either put the volunteer at risk because of participation in the study, or may influence the result of the study.
  • No response / confirmation from GP regarding previous medical history
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 NCT01623518
Other Study ID Numbers  ICMJE FLU004
2012-000641-12 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Oxford
Study Sponsor  ICMJE University of Oxford
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Adrian Hill, MD University of Oxford
PRS Account University of Oxford
Verification Date November 2014

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