Hepatitis B | The Effect of Alendronate on the Immune Response to Hepatitis B Vaccine in Healthy Adults
Hepatitis B research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - Subject willing to undergo hepatitis B vaccination AND be randomized to receive 4 doses of alendronate or placebo - Age 40-70 - Able to consent for self - ascertained by physician assessment at time of history and exam. - Chronic stable medical conditions, if well controlled on current therapies are allowed. For example individuals with well-controlled angina, hypertension, diabetes on oral agents, treated or past depression or anxiety, COPD, asthma, metabolic syndrome, NASH, mild chronic renal insufficiency, past history of malignancy, with no therapy for at least 5 years may be included. - Willing to use contraception, if a woman of child-bearing potential (WOCBP) Exclusion Criteria: - Pregnant, breastfeeding or planning a pregnancy - Prior Hepatitis B infection OR vaccination - Autoimmune disorders of any kind (e.g. multiple sclerosis, rheumatoid arthritis, lupus, Psoriasis etc.) - HIV or Hepatitis C seropositive - Any known immunodeficiency (decompensated cirrhosis, HIV/AIDS, prior bone marrow transplant, or other known immunodeficiency) - Patients on any immunosuppressive agents including systemic corticosteroids, calcineurin inhibitors, mTOR inhibitors, lymphocyte depleting biologic agents, anti-TNF agents, and others; chemotherapeutic anti-neoplastic agents within 5 years. Stable doses of inhaled corticosteroids for asthma/COPD are allowed. - Gastroesophageal reflux disease (GERD), peptic ulcer disease, chronic proton pump inhibitors, chronic antacid use - Chronic non-steroidal anti-inflammatory use; daily ASA for cardiac prophylaxis is allowed. - Esophageal disorders of any kind - Recent major dental work in the preceding 6 months, excluding dental cleaning and simple cavity filling - History of jaw trauma - Current or prior bisphosphonate use - Prior history of severe reactions to vaccines - Yeast or bisphosphonate allergy - History of hypocalcemia - Inability to stand or sit upright for at least 30 minutes. - Any malabsorptive disorder including celiac disease, CF, Inflammatory bowel disease, recurrent C. difficile colitis, other colitis, prior gastrectomy, bariatric surgery or chronic diarrhea. - Diabetes requiring insulin - Body mass index > 31
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:AlendronateParticipants will receive 4 doses of alendronate during the course of the study.
Drug:Hepatitis B VaccineParticipants will receive 3 Hepatitis B vaccinations, according to the schedule outlined by the CDC.
Drug:PlaceboParticipants will receive 4 doses of placebo during the course of the study.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Alendronate and Hepatitis B VaccineParticipants in the experimental arm will receive 4 alendronate doses during their Hepatitis B vaccination course.
Sugar Pill and Hepatitis B VaccineParticipants in the experimental arm will receive placebo doses during their Hepatitis B vaccination course.
Start Date: April 2014
Completed Date: February 2016
Phase: Phase 1
Primary Outcome: Safety/Adverse events
Secondary Outcome: Efficacy
Study sponsors, principal investigator, and references
Lead Sponsor: Massachusetts General Hospital