Prospective, Randomized and Comparative Study to evaluate the efficacy of two vaccines against Hepatitis B virus in inflammatory bowel disease patients

Prospective, Randomized and Comparative Study to evaluate the efficacy of two vaccines against Hepatitis B virus in inflammatory bowel disease patients - COMVI-B Proyect

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023947-14-ES

Enrollment

Unknown

Registered

2011-09-15

Start date

2011-07-15

Completion date

Unknown

Last updated

2016-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prophylaxis against Hepatitis B virus MedDRA version: 14.0 Level: LLT Classification code 10019743 Term: Hepatitis B virus (HBV) System Organ Class: 10022891 - Investigations

Interventions

Trade Name: ENGERIX-B 20µg / 1ml suspensión inyectable en jeringa precargada Product Name: FENDRIX Product Code: Not Applicable Pharmaceutical Form: Solution for injection INN or Proposed INN: ANTIGEN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients diagnosed of IBD with negative HBV serology. 2) Men & women commited to abstinence of sexual relations or to use, al least, an effective birth control method (condom, diaphragm, IUD) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 118 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 118

Exclusion criteria

Exclusion criteria: 1- Age below 18 years old. 2- Advanced Chronic Disease or any other disease that prevent from attending controls and follow-up. 3- Allergy to any of the vaccine components. 4- Previous vaccination to the HBV. 5- Women willing to get pregnant. 6- Pregnancy or breastfeeding. 7- alcohol abuse. 8- Positive serology to HBV. 9- People with immune disorders caused by other causes than treatments administered to control IBD. 10- People with chronic antibiotic treatment. 11- Lack of consent for participating in the study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the response rate to the vaccination to HBV in IBD patients.;Secondary Objective: 1) To compare response rate to the vaccination to HBV in patients with IBD of two types of vaccines: a) Engerix (double dose) in months 0, 1, 2 and 6 b) Fendrix in months 0,1,2 and 6 2) To identify the predictor factors to the HBV vaccine response (Specially in the treatment with immunosupresors such as azathioprine / mercaptopurine or biological treatment such as infliximab/adalimumab). 3) To study the kinetics of the decrease of anti-HBs title overtime in patients that initially responded to the HBV vaccine (this objective will be evaluated in a follow-up study);Primary end point(s): The main outcome will be the response to the vaccine defined as an anti-HBs title of 100 mUI/ml in month 2 after the last vaccine dose.;Timepoint(s) of evaluation of this end point: Two months after the last vaccine dose ( eight months after the start of the clinical trial)	—

Measure

Time frame

Main Objective: To evaluate the response rate to the vaccination to HBV in IBD patients.;Secondary Objective: 1) To compare response rate to the vaccination to HBV in patients with IBD of two types of vaccines: a) Engerix (double dose) in months 0, 1, 2 and 6 b) Fendrix in months 0,1,2 and 6 2) To identify the predictor factors to the HBV vaccine response (Specially in the treatment with immunosupresors such as azathioprine / mercaptopurine or biological treatment such as infliximab/adalimumab). 3) To study the kinetics of the decrease of anti-HBs title overtime in patients that initially responded to the HBV vaccine (this objective will be evaluated in a follow-up study);Primary end point(s): The main outcome will be the response to the vaccine defined as an anti-HBs title of 100 mUI/ml in month 2 after the last vaccine dose.;Timepoint(s) of evaluation of this end point: Two months after the last vaccine dose ( eight months after the start of the clinical trial)

—

Secondary

Measure	Time frame
Secondary end point(s): The response to the vaccine in accordance with age of the patient, gender, the type of IBD (Crohn´s Disease or ulcerative colitis) and the concomitant treatments.;Timepoint(s) of evaluation of this end point: Two months after the last vaccine dose ( eight months after the start of the clinical trial)	—

Countries

Spain

Contacts

Public ContactJavier Perez Gisbert

Hospital Universitario La Princesa

gisbert@meditex.es0034913093911

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026