Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03056924 · ClinicalTrials.gov registry record
Immunogenicity of Influenza, Pneumococcal and Hepatitis B Vaccines in IBD Patients Treated With Vedolizumab
A clinical trial, sponsored by Boston Medical Center.
- Completed
- Registry status
- 173
- Enrollment target
NCT03056924: Completed study, sponsored by Boston Medical Center.
NCT03056924 is a clinical trial that has completed, run by Boston Medical Center. The registered enrollment target is 173 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03056924 has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- 173 participants
- Enrollment target
Study Summary
Patients with Crohn's disease (CD) and ulcerative colitis (UC) are often treated with medications that suppress the immune system. These patients are therefore at increased risk for developing infections, such as influenza, pneumonia, and hepatitis B, which may be prevented by vaccination. While awareness is increasing among gastroenterologists of the importance of vaccinations in the IBD patient, there continues to be some question of the effectiveness of vaccination in immunosuppressed patients. It has been previously shown that patients on immunosuppressive therapy with certain biologic medications (the TNF-blockers: infliximab and adalimumab) had an impaired immune response to vaccination as compared to healthy controls, as the mechanism of immunosuppression for these agents is systemic. Vedolizumab, a biologic medication for CD and UC approved in May 2014, targets the α4β7 integrin, a key component of gut immunity, and as such it has been hypothesized that with this agent effects are gut specific. There is limited data that suggests that in healthy patients given vedolizumab do not have an altered response to parentally administered vaccines, however there are no studies in the CD and UC population describing this. Additionally, IBD patients treated with vedolizumab are frequently also on concomitant therapy with an immunomodulator (6-mercaptopurine, azathioprine, or methotrexate), and these patients ability to mount an immune response has not been demonstrated.
Primary Outcome
The primary outcome is percent change in IgG titer from baseline to 3 weeks post vaccination.
Interventions
- BIOLOGICAL Influenza vaccine
- BIOLOGICAL Hepatitis B vaccine
- BIOLOGICAL Pneumococcal Pneumonia vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2017-07-05 |
| Est. Completion | 2019-01-15 |
What the finished NCT03056924 record still lists
NCT03056924 is an observational study that tracks outcomes without assigning an intervention. The registered 173 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 3 interventions - of which Influenza vaccine is the first listed.
NCT03056924 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03056924 about?
NCT03056924 is a clinical study titled "Immunogenicity of Influenza, Pneumococcal and Hepatitis B Vaccines in IBD Patients Treated With Vedolizumab". Patients with Crohn's disease (CD) and ulcerative colitis (UC) are often treated with medications that suppress the immune system. These patients are therefore at increased risk for developing infections, such as influenza, pneumonia, and hepatitis B, which may be prevented by vaccination. While awa...
What is the current status of trial NCT03056924?
This trial is currently completed. The enrollment target is 173 participants. The study started on 2017-07-05. Estimated completion is 2019-01-15.
What interventions are being tested in trial NCT03056924?
The interventions under investigation include: Influenza vaccine (BIOLOGICAL), Hepatitis B vaccine (BIOLOGICAL), Pneumococcal Pneumonia vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03056924?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05568719 · 173 participants · Phase 3
Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively
- NCT07070115 · 173 participants · NA
Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®
- NCT07150832 · 173 participants · NA
Efficacy of the I-CARE Digital Health Intervention
- NCT01000259 · 174 participants
Study of Tumor Tissue Samples From Patients Who Have Undergone Surgery for Advanced Stage III or Stage IV Ovarian Epithelial Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI