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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: Completed Phase 1 study, sponsored by Wayne State University.
NCT01741012 is a Phase 1 study that has completed, run by Wayne State University. The registered enrollment target is 37 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Frequency of participants with Vaccine site reactions, Frequency of participants with Non Vaccine Adverse Events,
Interventions
- DRUG Gardasil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2013-01 |
| Est. Completion | 2015-11 |
| Phase | Phase 1 |
What the finished NCT01741012 record still lists
NCT01741012 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 1 intervention - of which Gardasil is the first listed.
NCT01741012 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01741012's enrollment target sits among peer trials
37 1204th of 2000 higher than 791 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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