drugset / Trial / NCT02057263

The Effect of Alendronate on the Immune Response to Hepatitis B Vaccine in Healthy Adults

NCT02057263

Phase 1 Completed 28 enrolled Massachusetts General Hospital
RandomizedParallel-groupTriple-blindPrevention

Summary

Vaccines are one of our most effective public health tools but many who need them don't respond well and are not protected. Adjuvants boost immune responses and are commonly included in vaccine preparations. Bisphosphonates are the most commonly prescribed treatment for osteoporosis and may represent a new class of adjuvant. Bisphosphonates are well tolerated with chronic administration and have very few adverse effects. Research suggests that these medications can stimulate the immune system. Bisphosphonates are of special interest in populations with impaired immunity and an inability to amount protective antibody responses following immunizations. We propose a pilot study to evaluate the clinical relevance of this finding in humans. We will study the effect of bisphosphonates on quantitative humoral immune response to hepatitis B vaccine in healthy older volunteers who have not previously received this vaccine.

Timeline

Start
2014-04
Primary completion
2016-02
Completion
2016-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Alendronic Acid Small molecule
Subject Hepatitis B vaccine Vaccine Intramuscular