Crohn's disease Digestive System
Conditions
Interventions
Participants will be randomised 1:1 using a computer-generated randomisation schedule to receive either the investigational vaccine or a placebo.
ChAdOx2 HAV: viral vectored vaccine using a chimpanz
Sponsors
HAV Vaccines Limited
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 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 the ileum or colon on a colonoscopy or flexible sigmoidoscopy 5. No immunomodulatory treatment (thiopurines, methotrexate, tacrolimus, anti-TN alpha 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 serum hCG 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
Exclusion criteria
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 the interpretation of the trial data 3. Prior receipt of an adenoviral vectored vaccine (or any other 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 10. Unable to provide written informed consent 11. Pregnancy, lactation or willingness/intention to become pregnant during the study 12. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) 13. History of a serious psychiatric condition likely to affect participation in the study 14. Bleeding disorder (e.g. Factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture 15. Any other serious chronic illness requiring hospital specialist supervision 16. Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week 17. Suspected or known injecting drug abuse in the 5 years preceding enrolment 18. Seropositive for hepatitis C (antibodies to HCV) 19. Seropositive for hepatitis B surface antigen (HBsAg) 20. Any clinically significant abnormal finding on screening biochemistry or hematology blood tests, urinalysis, or a positive test for SARS-COV-2 (Covid-19) at screening 21. Any other significant disease, disorder or finding which may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to take part in the study or impair interpretation of the study data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Remission at day 112 measured using the Crohn's Disease Activity Index (CDAI)/Simple Endoscopic Score for Crohn's Disease (SES-CD) at baseline, before administration of study treatment at day 0, and day 112 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability measured using data collected on the incidence, severity and relationship of adverse events, adverse reactions, serious adverse events and serious adverse reactions from first vaccination until study completion, with data access at one timepoint at the end of the study;Immunogenicity, assessed via vaccine-specific immune responses, measured using immunological assays including ELISpot and related laboratory assessments at at baseline (before administration of study treatment at day 0) and post-vaccination study visits;Crohn's disease activity measured using the Crohn's Disease Activity Index (CDAI) and endoscopic assessment at assessments throughout the study period | — |
Countries
England, United Kingdom
Contacts
Public ContactJeremy Sanderson
Outcome results
None listed