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NCT05672927 · ClinicalTrials.gov registry record · Phase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
A Phase 4 study of Human Papilloma Virus and HPV Infection, sponsored by The University of Texas Medical Branch, Galveston.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 618
- Enrollment target
- 1
- Study location
NCT05672927: Recruiting Phase 4 study of Human Papilloma Virus and HPV Infection, sponsored by The University of Texas Medical Branch, Galveston.
NCT05672927 is a Phase 4 study of Human Papilloma Virus and HPV Infection that is actively recruiting participants, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 618 participants, below the 8,425-participant average among 39 other Human Papilloma Virus trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05672927, a Phase 4 study of Human Papilloma Virus and HPV Infection, is actively recruiting participants, sponsored by The University of Texas Medical Branch, Galveston.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 618 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to compare a 2-dose and 3-dose series of 9vHPV vaccine among 27-45-year-old females to assess if 2 doses elicit a noninferior immune response. Participants will be randomized 1:1 to either the 2-dose group or the 3-dose group and asked to provide 4 blood samples over a period of 12 months. All 2-dose participants will be offered a 3rd dose after the final blood draw,12 months after their initial vaccination.
Primary Outcome
Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-6, measured as number of participants.
Conditions Studied
Interventions
- BIOLOGICAL 9-valent HPV vaccine, 2 doses alternate timing
- BIOLOGICAL 9-valent HPV vaccine, 3 doses standard timing
Study Locations (1)
Texas
- University of Texas Medical Branch - Galveston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 618 participants |
| Start Date | 2023-01-18 |
| Est. Completion | 2027-08 |
| Phase | Phase 4 |
What NCT05672927 shows while recruiting
NCT05672927 is an interventional study that assigns participants to a tested intervention. The registered 618 participants enrollment target is mid-sized for trials with a published cap, below the 8,425-participant average among 39 other Human Papilloma Virus trials with a reported enrollment target (93% lower).
The record links to 3 conditions, with Human Papilloma Virus appearing as the primary indexed condition, and to 2 interventions - of which 9-valent HPV vaccine, 2 doses alternate timing is the first listed.
NCT05672927 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05672927 about?
NCT05672927 is a clinical study titled "Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)". The goal of this clinical trial is to compare a 2-dose and 3-dose series of 9vHPV vaccine among 27-45-year-old females to assess if 2 doses elicit a noninferior immune response. Participants will be randomized 1:1 to either the 2-dose group or the 3-dose group and asked to provide 4 blood samples ov...
What is the current status of trial NCT05672927?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 618 participants. The study started on 2023-01-18. Estimated completion is 2027-08.
What conditions does trial NCT05672927 study?
This clinical trial studies the following conditions: Human Papilloma Virus, HPV Infection, Immunization.
What interventions are being tested in trial NCT05672927?
The interventions under investigation include: 9-valent HPV vaccine, 2 doses alternate timing (BIOLOGICAL), 9-valent HPV vaccine, 3 doses standard timing (BIOLOGICAL).
Who is sponsoring clinical trial NCT05672927?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05672927 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05672927's enrollment target sits among peer trials
618 13th of 39 higher than 27 of 39 other Human Papilloma Virus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Human Papilloma Virus 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.
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