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NCT05031078 · ClinicalTrials.gov registry record · Phase 4
Assessing Durable Antibody Response to HPV Vaccination
A Phase 4 study of Hpv, sponsored by Emory University.
- Active
- Registry status
- Phase 4
- Development phase
- 17
- Enrollment target
- 2
- Study locations
NCT05031078: Active Phase 4 study of Hpv, sponsored by Emory University.
NCT05031078 is a Phase 4 study of Hpv that is active but no longer recruiting, run by Emory University. The registered enrollment target is 17 participants, below the 2,241-participant average among 24 other Hpv trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05031078, a Phase 4 study of Hpv, is active but no longer recruiting, sponsored by Emory University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 17 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a single center, longitudinal cohort study in which subjects will receive 9-valent HPV vaccine according to package insert (i.e., one dose of 9-valent HPV vaccine on day (D) 0 followed by a second dose 2 months later and a third dose 6 months later). Immune responses in the blood, saliva, bone marrow, and lymph nodes will be assessed in subjects receiving the HPV vaccine. Blood samples for immunologic testing will be collected at screening (from D-60 to D-45), on D0 (before vaccination), D1 (optional visit), D7±1, D14±5, D30±5, D60±5 (Visit 8, before vaccination), Visit 8 +1 day (optional visit), Visit 8 + 7±1 days, Visit 8 + 14±5 days, Visit 8 + 30±5 days, D180±5 (Visit 13, before vaccination), Visit 13 + 7±1 days, Visit 13 + 14±5 days, Visit 13 + 30±5 days, D365±14, D730±14, D1095±14, D1460±14, D1825±30. Saliva samples for antibody testing will be collected on D0 (before vaccination), D30, D60 (before vaccination), Visit 8 + 30±5 days, D180 (before vaccination), Visit 13 + 30±5 days, D365, and D730. Axillary lymph node sampling by fine needle aspiration will be done 3 times per group. Group 1 will have lymph node sampling done D-30 to D0, D14, and D30. Group 2 will have lymph node sampling done D60, Visit 8 + 14±5 days, and Visit 8 + 30±5 days. Group 3 will have lymph node sampling D180, Visit 13 + 14±5 days, and Visit 13 + 30±5 days. Bone marrow sampling will be done for all groups at D730±14 and D1825±30.
Primary Outcome
Determining the number of participants with a minimum four-fold rise in post-vaccination HPV-16 and HPV-18 neutralizing antibody titers determined using an HPV pseudovirus neutralization assay
Conditions Studied
Interventions
- BIOLOGICAL Gardasil-9
- DRUG Lidocaine injections
Study Locations (2)
Georgia
- The Hope Clinic of Emory University - Atlanta
- Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2021-12-21 |
| Est. Completion | 2026-05 |
| Phase | Phase 4 |
What the registry record for NCT05031078 still lists
NCT05031078 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 2,241-participant average among 24 other Hpv trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Hpv appearing as the primary indexed condition, and to 2 interventions - of which Gardasil-9 is the first listed.
NCT05031078 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT05031078 about?
NCT05031078 is a clinical study titled "Assessing Durable Antibody Response to HPV Vaccination". This is a single center, longitudinal cohort study in which subjects will receive 9-valent HPV vaccine according to package insert (i.e., one dose of 9-valent HPV vaccine on day (D) 0 followed by a second dose 2 months later and a third dose 6 months later). Immune responses in the blood, saliva, b...
What is the current status of trial NCT05031078?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2021-12-21. Estimated completion is 2026-05.
What conditions does trial NCT05031078 study?
This clinical trial studies the following conditions: Hpv.
What interventions are being tested in trial NCT05031078?
The interventions under investigation include: Gardasil-9 (BIOLOGICAL), Lidocaine injections (DRUG).
Who is sponsoring clinical trial NCT05031078?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05031078 being conducted?
This trial has 2 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hpv
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05031078's enrollment target sits among peer trials
17 25th of 24 the lowest of 24 other Hpv trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hpv 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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