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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). 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.
Primary Outcome
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 duratio
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 |
What the finished NCT02057263 record still lists
NCT02057263 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02057263 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02057263's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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