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NCT00091130 · ClinicalTrials.gov registry record · Phase 2

SGN-00101 Vaccine in Treating Human Papillomavirus in Patients Who Have Abnormal Cervical Cells

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
139
Enrollment target

NCT00091130: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT00091130 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 139 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00091130, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
139 participants
Enrollment target

Study Summary

This randomized phase II trial is studying how well SGN-00101 vaccine works compared to a placebo in treating human papillomavirus and preventing cervical cancer in patients with abnormal cervical cells. Vaccines, such as SGN-00101, may make the body build an immune response to kill human papillomavirus and abnormal cervical cells and may be effective in preventing cervical cancer

Primary Outcome

Following the univariate modeling, multivariate logistic regression models will be constructed by adding the demographic factors, baseline viral load, and type of cellular atypia to the model. The univariate logistic regression model for infection resolution is equivalent to a chi-square test.

Interventions

  • OTHER laboratory biomarker analysis
  • OTHER placebo
  • BIOLOGICAL HspE7

Trial Details

FieldValue
Enrollment Target 139 participants
Start Date 2004-09
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00091130 record still lists

NCT00091130 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 3 interventions - of which laboratory biomarker analysis is the first listed.

NCT00091130 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00091130 about?

NCT00091130 is a clinical study titled "SGN-00101 Vaccine in Treating Human Papillomavirus in Patients Who Have Abnormal Cervical Cells". This randomized phase II trial is studying how well SGN-00101 vaccine works compared to a placebo in treating human papillomavirus and preventing cervical cancer in patients with abnormal cervical cells. Vaccines, such as SGN-00101, may make the body build an immune response to kill human papillomav...

What is the current status of trial NCT00091130?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 139 participants. The study started on 2004-09.

What interventions are being tested in trial NCT00091130?

The interventions under investigation include: laboratory biomarker analysis (OTHER), placebo (OTHER), HspE7 (BIOLOGICAL).

Who is sponsoring clinical trial NCT00091130?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00091130's enrollment target sits among peer trials

139 525th of 2000 higher than 1,476 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT00091130, the US trial registry maintained by the National Library of Medicine. NCT00091130 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.