Printed from Voxsanity (voxsanity.com.au) — ISRCTN13731766 — Data sourced from the ISRCTN registry. Verify directly with the trial site before attending. Not medical advice.
Back to Crohns Disease And Colitis
Phase 2 Crohn's Disease and Colitis Trial, Not Yet Recruiting
ISRCTN13731766
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- Adults aged between 18 and 50 years old.
- People who have a confirmed diagnosis of Crohn's disease, identified through standard clinical, imaging, camera, or tissue tests.
- People whose Crohn's disease is mildly to moderately active, shown by at least one of the following: a raised blood inflammation marker (CRP above 10mg/L), a raised stool inflammation marker (faecal calprotectin above 150), or a disease activity score (CDAI) between 150 and 320.
- People who have active Crohn's inflammation visible in at least one part of the small intestine or large intestine on a camera examination (colonoscopy or flexible sigmoidoscopy).
- People who are not currently taking, and have not taken in the last 3 months, any immune-suppressing medications such as thiopurines, methotrexate, tacrolimus, or certain biological therapies (confirm with trial site).
- People who are able to follow all of the requirements of the study.
- Women who are willing to use reliable contraception throughout the study and who have a negative pregnancy blood test on the day(s) of screening and vaccination.
- People who agree not to donate blood during the study.
- People who are willing and able to give written consent to participate.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have taken part in another research study involving an experimental treatment in the 30 days before enrolling, or who plan to do so during the study.
- People who have previously received an experimental vaccine that could affect how the trial results are interpreted.
- People who have received an adenoviral-based vaccine or any other vaccine in the last 28 days.
- People who have received immunoglobulins or any blood products in the three months before the planned vaccine dose.
- People who have a confirmed or suspected weakened immune system, including HIV infection, a missing spleen, or a history of frequent severe infections.
- People who are currently taking, or have taken in the last 3 months, any immune-suppressing medications, including steroid tablets or injections (but not inhaled or skin-applied steroids), thiopurines, methotrexate, tacrolimus, or any biological therapy.
- People with a history of allergic reactions that may be triggered by any ingredient in the vaccine (for example, egg allergy).
- People with any history of hereditary, acquired, or unexplained angioedema (a condition causing sudden swelling under the skin).
- People with any history of a severe allergic reaction (anaphylaxis) following a vaccination.
- People who are unable to give written informed consent.
- People who are pregnant, breastfeeding, or who intend to become pregnant during the study.
- People with a history of cancer, except for certain skin cancers (basal cell carcinoma) or cervical cell changes that have been treated (cervical carcinoma in situ).
- People with a history of a serious psychiatric condition that is likely to affect their ability to take part in the study.
- People with a bleeding disorder or a history of significant bleeding or bruising after injections or blood tests.
- People with any other serious long-term illness that requires ongoing specialist hospital care.
- People with suspected or known alcohol use above 42 units per week.
- People with suspected or known injecting drug use in the five years before enrolling.
- People who test positive for hepatitis C antibodies.
- People who test positive for the hepatitis B surface antigen.
- People who have any significant abnormal results on screening blood tests, urine tests, or who test positive for COVID-19 at screening.
- People who have any other significant disease, condition, or finding that could increase the risk of harm from participating, affect their ability to take part, or make the study results harder to interpret.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from the ISRCTN registry. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
HAV Vaccines Limited
Registry
ISRCTN registry
Start date
1 November 2026
Est. completion
30 September 2028
Where this trial is recruiting
England
🇬🇧 United Kingdom
Can't join this trial?
Data last synced from the ISRCTN registry: 10 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.
View original record on ISRCTN ↗
Source: ISRCTN registry (isrctn.com), data processed 10 August 2026. ISRCTN metadata is CC0; contribution content is CC BY 4.0.