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NCT02057263 · ClinicalTrials.gov registry record · Phase 1
The Effect of Alendronate on the Immune Response to Hepatitis B Vaccine in Healthy Adults
A Phase 1 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT02057263: Completed Phase 1 study, sponsored by Massachusetts General Hospital.
NCT02057263 is a Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 28 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02057263, a Phase 1 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Alendronate
- DRUG Hepatitis B Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2014-04 |
| Est. Completion | 2016-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02057263
The ClinicalTrials.gov registry entry for NCT02057263 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02057263 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02057263 about?
NCT02057263 is a clinical study titled "The Effect of Alendronate on the Immune Response to Hepatitis B Vaccine in Healthy Adults". 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 represen...
What is the current status of trial NCT02057263?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2014-04. Estimated completion is 2016-02.
What interventions are being tested in trial NCT02057263?
The interventions under investigation include: Placebo (DRUG), Alendronate (DRUG), Hepatitis B Vaccine (DRUG).
Who is sponsoring clinical trial NCT02057263?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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