Trial record 16 of 443 for:    hepatitis b | Open Studies

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

This study is not yet open for participant recruitment.
Verified February 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Elizabeth L. Hohmann, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02057263
First received: February 4, 2014
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: Alendronate
Drug: Hepatitis B Vaccine
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Alendronate on the Immune Response to Hepatitis B Vaccine in Healthy Adults - a Randomized Placebo-controlled Pilot Study

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Safety/Adverse events [ Time Frame: 5 months after final alendronate administration/second vaccination ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 8 weeks to 5 months after final alendronate dose ] [ Designated as safety issue: No ]
    Efficacy is assessed by quantitative Anti Hepatitis B Surface IgG (immunoglobulin G) antibody titers in international units (iU) per ml. All subjects must have levels of ZERO in order to participate. A value of 10 iU/ml is considered protective. Titers directed against hepatitis B surface antigen will be measured by commercially available testing Efficacy will also be assessed as a categorical value: Yes/No for protective level of antibody achieved at either 8 weeks or 6 months (5 months after second vaccination). A protective level of hepatitis B surface antibody is defined as 10 iU/ml; levels of 10-100 are considered protective but "poorly responsive." We will compare mean titers between groups (placebo vs. alendronate). We believe a mean increase of 20% is likely clinically significant/important.


Estimated Enrollment: 20
Study Start Date: February 2014
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alendronate and Hepatitis B Vaccine
Participants in the experimental arm will receive 4 alendronate doses during their Hepatitis B vaccination course.
Drug: Alendronate
Participants will receive 4 doses of alendronate during the course of the study.
Other Names:
  • Fosamax
  • Bisphosphonate
Drug: Hepatitis B Vaccine
Participants will receive 3 Hepatitis B vaccinations, according to the schedule outlined by the CDC.
Experimental: Sugar Pill and Hepatitis B Vaccine
Participants in the experimental arm will receive placebo doses during their Hepatitis B vaccination course.
Drug: Hepatitis B Vaccine
Participants will receive 3 Hepatitis B vaccinations, according to the schedule outlined by the CDC.
Drug: Placebo
Participants will receive 4 doses of placebo during the course of the study.
Other Name: Sugar Pill

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 schlerosis, 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.
  • Gastroesphageal 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02057263

Contacts
Contact: Elizabeth Hohmann, MD 617-724-8625 ehohmann@partners.org
Contact: Christina Pindar, BA 617-724-8625 cpindar@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Elizabeth Hohmann, MD    617-724-8625    ehohmann@partners.org   
Principal Investigator: Elizabeth Hohmann, MD         
Sub-Investigator: Ilan Youngster, MD         
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Elizabeth L. Hohmann, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02057263     History of Changes
Other Study ID Numbers: 2014-P-000040
Study First Received: February 4, 2014
Last Updated: February 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Vaccine
Adjuvant
Bisphosphonates
Alendronate
Hepatitis B vaccine

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Diphosphonates
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014