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NCT01741012 · ClinicalTrials.gov registry record · Phase 1
Study to Determine if Gardasil Vaccine is Safe and Effective in Lupus Patients
A Phase 1 study, sponsored by Wayne State University.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
NCT01741012 is a Phase 1 study that has completed, run by Wayne State University. The registered enrollment target is 37 participants.
The verdict
NCT01741012, a Phase 1 study, has completed, sponsored by Wayne State University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
Study Summary
Cervical neoplasia is increased in women with SLE most likely due to cervical infection with human papilloma virus (HPV). 70% of cervical cancer is caused by HPV types 16 and 18. Gardasil vaccine prevents cervical infection with HPV types 16 and 18. Thus lupus patients (who are susceptible to cervical cancer) may benefit from getting Gardasil vaccine which can prevent cervical cancer. Vaccines are generally safe and efficacious in SLE but no studies have been done on the use of this vaccine in SLE. The investigators hypothesize that Gardasil vaccine is safe and effective in SLE. This study will look at vaccine safety in patients with mild to moderate and minimally active or inactive SLE and measure how well they make protective antibodies after receiving the vaccine. In other words this will check how well the vaccine works in SLE.
Interventions
- DRUG Gardasil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2013-01 |
| Est. Completion | 2015-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01741012
The ClinicalTrials.gov registry entry for NCT01741012 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wayne State University, which has 163 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Gardasil is the first listed.
NCT01741012 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01741012 about?
NCT01741012 is a clinical study titled "Study to Determine if Gardasil Vaccine is Safe and Effective in Lupus Patients". Cervical neoplasia is increased in women with SLE most likely due to cervical infection with human papilloma virus (HPV). 70% of cervical cancer is caused by HPV types 16 and 18. Gardasil vaccine prevents cervical infection with HPV types 16 and 18. Thus lupus patients (who are susceptible to cervic...
What is the current status of trial NCT01741012?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2013-01. Estimated completion is 2015-11.
What interventions are being tested in trial NCT01741012?
The interventions under investigation include: Gardasil (DRUG).
Who is sponsoring clinical trial NCT01741012?
This trial is sponsored by Wayne State University, which has 163 total clinical trials registered on ClinicalTrials.gov.
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