A clinical trial to determine the safety, tolerability and immunogenicity of the candidate Mycobacterium avium subspecies paratuberculosis (MAP) vaccines ChAdOx2 HAV and MVA HAV in patients with active Crohn’s disease

HAV Vaccines Limited0 sites28 target enrollmentMarch 3, 2020

Overview

No summary available.

Registry

who.int

Start Date

March 3, 2020

End Date

November 19, 2022

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•1\. Age 18 to 50 years.
•2\. Confirmed diagnosis of Crohn’s disease diagnosed according to standard clinical, endoscopic, radiological or histological criteria.
•3\. Mild to moderately active Crohn’s inflammation as defined by one or more of a raised CRP \>10mg/L, faecal calprotectin \>150 and a CDAI \>150 but \<320\.
•4\. Active Crohn’s inflammation in at least one segment of ileum or colon on colonoscopy or flexible sigmoidoscopy.
•5\. No immunomodulatory treatment (thiopurines, methotrexate, tacrolimus, anti\-TNFalpha antibody therapy, anti\-alpha4beta7 antibody therapy, anti\-p40 antibody therapy) currently or within the last 3 months.
•6\. Able to comply with all study requirements.
•7\. 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.
•8\. Agreement to refrain from blood donation during the course of the study.
•9\. Provide written informed consent.

•Current exclusion criteria as of 18/11/2021:
•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\. Prior receipt of an adenoviral vectored vaccine in the last 28 days.
•4\. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
•5\. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections.
•6\. Any immunosuppressive medication currently or within the preceding 3 months including corticosteroids (except inhaled steroid or topical steroid), thiopurines, methotrexate, tacrolimus and any biological therapy.
•7\. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (e.g. Egg allergy)
•8\. Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
•9\. Any history of anaphylaxis in relation to vaccination.