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NCT01092195 · ClinicalTrials.gov registry record · Phase 1
Gardasil Vaccination in Post Stem Cell Transplant Patients
A Phase 1 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
NCT01092195: Completed Phase 1 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT01092195 is a Phase 1 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 64 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01092195, a Phase 1 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
Study Summary
Background: * Gardasil , a recently approved vaccine for the sexually transmitted human papillomavirus (HPV), provides immunity to four types of HPV that are associated with genital warts and cervical, vaginal, and vulvar precancer and cancer. The vaccine has been shown to be highly effective in preventing infection with these HPV types and was approved for use by the Food and Drug Administration. * More research is needed about the vaccine s ability to induce immunity in individuals with suppressed immune systems, such as those who have had other kinds of cancer treatment such as stem cell transplant. Genital warts, precancer, and cancer have been reported as a late complication after stem cell transplant. Researchers are interested in determining whether the HPV vaccine is safe to give and able to induce immunity in female stem cell transplant recipients, their female donors, and healthy female volunteers. Objectives: \- To assess the safety and immune response of the HPV vaccine in female recipients of stem cell transplants who are either off or on stable doses of immunosuppression. Eligibility: * Females between 18 and 50 years of age who have had allogenic stem cell transplants. * Healthy female volunteers, including stem cell donors, are also eligible for this study. Design: * Participants will be screened with a physical examination, blood and urine tests, and saliva samples, and will be asked to complete a sexual quality of life questionnaire. * Sexually active participants will also have a routine gynecologic evaluation. * Participants will receive three HPV vaccinations according to the standard vaccination schedule (with the second and third following 2 and 6 months after the first). Participants will record their daily temperature and any reactions to the vaccine on a vaccine report card for 1 week after each vaccination. * Participants will have clinic visits for further testing 2, 6, 7, and 12 months after receiving the first HPV vaccine.
Primary Outcome
The percentage of subjects who developed antibody response to the quadrivalent HPV (qHPV) vaccine (HPV - 6/ - 11/ - 16/ - 18). Anti-HPV-6/11/16/18-specific antibody responses using L1 Virus Like Particle (VLP) ELISA were measured in serum.
Interventions
- BIOLOGICAL Gardasil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2010-06-02 |
| Est. Completion | 2016-07-19 |
| Phase | Phase 1 |
What the finished NCT01092195 record still lists
NCT01092195 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Gardasil is the first listed.
NCT01092195 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01092195 about?
NCT01092195 is a clinical study titled "Gardasil Vaccination in Post Stem Cell Transplant Patients". Background: * Gardasil , a recently approved vaccine for the sexually transmitted human papillomavirus (HPV), provides immunity to four types of HPV that are associated with genital warts and cervical, vaginal, and vulvar precancer and cancer. The vaccine has been shown to be highly effective in pr...
What is the current status of trial NCT01092195?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2010-06-02. Estimated completion is 2016-07-19.
What interventions are being tested in trial NCT01092195?
The interventions under investigation include: Gardasil (BIOLOGICAL).
Who is sponsoring clinical trial NCT01092195?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01092195's enrollment target sits among peer trials
64 808th of 2000 higher than 1,181 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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