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NCT00798265 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of Quadrivalent Human Papilloma Virus (HPV) (Types 6, 11, 16, 18) Recombinant Vaccine in HIV-Infected and HIV-Negative Pre-Adolescents, Adolescents, and Young Adults
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT00798265: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00798265 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 26 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00798265, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
Background: * Human papilloma virus (HPV) is a common sexually transmitted disease. There are more than 100 different HPV types, and both males and females can get HPV infection. Most people do not have any symptoms when they become infected and are able to get rid of the infection on their own. However, they can still become re-infected with the same or a different HPV type, and in some people HPV infection persists. * Persistent HPV infection is associated with the development of precancerous lesions and cancer. HPV types are classified as either high risk or low risk based on whether their persistence will lead to cancer. * Patients who have suppressed immune systems are at a higher risk for HPV-related complications. They are more likely to contract multiple HPV types and have more persistent infection that can lead to precancerous lesions or cancer, which are then difficult to treat and often recur. * A recently approved vaccine for HPV induces immunity to HPV 6, 11, 16, and 18. It was shown to be highly effective in preventing infection with these HPV types, and is approved for use in females 9 to 26 years of age. However, much less is known about the vaccines ability to induce immunity in males or individuals with suppressed immune systems. Objectives: \- To investigate whether the HPV vaccine is safe to give and able to induce immunity in both female and male adolescents and young adults with HIV infection compared to healthy, human immunodeficiency virus (HIV)-negative persons of the same age. Eligibility: \- Males and females, 12 to 26 years of age, divided into three groups: (1) Healthy and HIV-negative, (2) HIV-positive and on antiretroviral therapy, and (3) HIV-positive and not on antiretroviral therapy. Design: * Before beginning vaccination, participants will have a complete physical examination and blood drawn for routine blood tests, special tests of the immune system, antibody tests, and an HIV test. * HPV vaccine will be given by injection
Interventions
- BEHAVIORAL Survey
- BIOLOGICAL Gardasil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2009-06-29 |
| Est. Completion | 2013-02-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00798265
The ClinicalTrials.gov registry entry for NCT00798265 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Survey is the first listed.
NCT00798265 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00798265 about?
NCT00798265 is a clinical study titled "A Phase I Study of Quadrivalent Human Papilloma Virus (HPV) (Types 6, 11, 16, 18) Recombinant Vaccine in HIV-Infected and HIV-Negative Pre-Adolescents, Adolescents, and Young Adults". Background: * Human papilloma virus (HPV) is a common sexually transmitted disease. There are more than 100 different HPV types, and both males and females can get HPV infection. Most people do not have any symptoms when they become infected and are able to get rid of the infection on their own. Ho...
What is the current status of trial NCT00798265?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2009-06-29. Estimated completion is 2013-02-04.
What interventions are being tested in trial NCT00798265?
The interventions under investigation include: Survey (BEHAVIORAL), Gardasil (BIOLOGICAL).
Who is sponsoring clinical trial NCT00798265?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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