drugset / Trial / NCT03798691

Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab

NCT03798691

Non-randomizedParallel-groupOpen-labelBasic science

Summary

Inflammatory bowel disease (IBD) is a chronic inflammatory state of the gastrointestinal tract affecting 1.6-3.1 million people in the United States. Patients with IBD are treated with immunosuppressants that increase their risk of herpes zoster (HZ), also known as shingles. Those with IBD have a two-fold increased risk for HZ compared to age matched controls. Because most IBD patients are treated with systemic immunosuppressants, which are an independent risk factor for HZ, the live attenuated HZ vaccine was not recommended. However, the release of the new inactivated HZ vaccine, Shingrix (GlaxoSmithKline), presents new opportunities for preventive care.

Timeline

Start
2019-05-28
Primary completion
2023-10-12
Completion
2024-09-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator VARICELLA ZOSTER VIRUS ENVELOPE GLYCOPROTEIN E Vaccine 0.5 ml Intramuscular