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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 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.

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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.

Conditions Studied

Hpv

Interventions

  • BIOLOGICAL Gardasil-9
  • DRUG Lidocaine injections

Study Locations (2)

Georgia

  • The Hope Clinic of Emory University - Atlanta
  • Winship Cancer Institute - Atlanta

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2021-12-21
Est. Completion 2026-05
Phase Phase 4

Sponsor

Emory University

1,208 total trials

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What the Registry Record Tells You About NCT05031078

The ClinicalTrials.gov registry entry for NCT05031078 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,241-participant average among 24 other Hpv trials with a reported enrollment target (99% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.