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NCT07090174 · ClinicalTrials.gov registry record · Phase 2
Testing for Safety and Immune Effects of PDS0101, an Anti-HPV Therapy, Among People Living With HIV
A Phase 2 study, sponsored by Weill Medical College of Cornell University.
- Not yet
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT07090174: Clinical Trial Phase 2 study, sponsored by Weill Medical College of Cornell University.
NCT07090174 is a Phase 2 study that has not yet begun recruiting, run by Weill Medical College of Cornell University. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07090174, a Phase 2 study, has not yet begun recruiting, sponsored by Weill Medical College of Cornell University.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
This study is testing the immunotherapeutic agent, PDS0101, in adults living with HIV who are also infected with human papillomavirus (HPV) type 16. The purpose of the study is to learn whether PDS0101 is safe and whether it can help the body's immune system respond to HPV 16. Researchers will enroll 27 adults between the ages of 25 and 65 who have been receiving antiretroviral therapy (ART) for at least 12 months, have a cluster of differentiation 4 (CD4) cell count of at least 200 cells/mm³, and have an HIV viral load below 200 copies/mL. All participants must have HPV 16 detected in the cervix, vagina, or anus. Some participants will have high-grade squamous intraepithelial lesions (HSIL), a condition that can lead to cancer. At least 10 participants will have cervical HSIL, and at least 10 will have anal HSIL. Participants with both cervical and anal HSIL will count in both groups. Others may have HPV 16 without HSIL. This is a single-arm, open-label trial, which means that all participants will receive the same treatment, and both the investigators and the participants will know what the treatment is. Each participant will receive three doses of the PDS0101 vaccine. Participants who receive at least one dose will be included in the study's main safety analysis. If a participant does not receive all three doses and does not experience a serious side effect related to the vaccine (defined as a Grade 3 or higher toxicity), that participant may be replaced to make sure that 27 participants either complete the full vaccination schedule or experience a primary safety event. Participants who do have a qualifying safety event will not be replaced. Even if someone stops the study early, their data will still be included in the final analysis. The main goals of this study are to evaluate the safety of PDS0101 and to measure the immune response it produces. The safety evaluation includes monitoring for serious or unexpected side effects, especially those that are Grade
Interventions
- BIOLOGICAL PDS0101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2025-10-20 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 2 |
What is known before NCT07090174 opens enrollment
NCT07090174 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which PDS0101 is the first listed.
NCT07090174 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07090174 about?
NCT07090174 is a clinical study titled "Testing for Safety and Immune Effects of PDS0101, an Anti-HPV Therapy, Among People Living With HIV". This study is testing the immunotherapeutic agent, PDS0101, in adults living with HIV who are also infected with human papillomavirus (HPV) type 16. The purpose of the study is to learn whether PDS0101 is safe and whether it can help the body's immune system respond to HPV 16. Researchers will enrol...
What is the current status of trial NCT07090174?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2025-10-20. Estimated completion is 2026-07-31.
What interventions are being tested in trial NCT07090174?
The interventions under investigation include: PDS0101 (BIOLOGICAL).
Who is sponsoring clinical trial NCT07090174?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07090174's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 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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