The Effect of Alendronate on the Immune Response to Hepatitis B Vaccine in Healthy Adults
1 other identifier
interventional
28
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2014
CompletedFirst Posted
Study publicly available on registry
February 7, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedOctober 21, 2016
October 1, 2016
1.8 years
February 4, 2014
October 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety/Adverse events
Safety is assessed by clinical symptoms and exam at final in-person visit. Standardized CTAE will be recorded and graded (mild/moderate/severe) with a special focus on vaccine related adverse events: Temperature, local injection site reactions, fatigue and malaise, AND adverse events related to alendronate which are primarily gastrointestinal: nausea, vomiting, esophagitis, ulceration. Rare, unlikely events such as atypical fractures and jaw osteonecrosis are extremely unlikely with this duration of dosing (4 weekly doses) but will also be specifically sought.
5 months after final alendronate administration/second vaccination
Secondary Outcomes (1)
Efficacy
8 weeks to 5 months after final alendronate dose
Study Arms (2)
Alendronate and Hepatitis B Vaccine
EXPERIMENTALParticipants in the experimental arm will receive 4 alendronate doses during their Hepatitis B vaccination course.
Sugar Pill and Hepatitis B Vaccine
EXPERIMENTALParticipants in the experimental arm will receive placebo doses during their Hepatitis B vaccination course.
Interventions
Participants will receive 4 doses of alendronate during the course of the study.
Participants will receive 3 Hepatitis B vaccinations, according to the schedule outlined by the CDC.
Participants will receive 4 doses of placebo during the course of the study.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 4, 2014
First Posted
February 7, 2014
Study Start
April 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
October 21, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Available upon request