Assessing Durable Antibody Response to HPV Vaccination

NCT05031078 | Active Not Recruiting Phase 4 Results DMC FDA Drug

• 1 other identifier: STUDY00002830
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief 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

HPV

Keywords

HPV

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Minimum Four-fold Rise in Post-vaccination HPV-16 and HPV-18 Neutralizing Antibody Titers

  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

  30 days after receiving the third and final vaccine dose (approximately Day 210 after first vaccine dose)

Secondary Outcomes (1)

• Change in Number of HPV-specific Memory B Cell (Bmem) Response From Baseline

  Baseline (Day 0), Day 30, Day 180, Day 210, Day 365, Day 730 post-intervention

Study Arms (3)

Group 1: Lymph node sampling at D-30 to D0, D14 and D30

EXPERIMENTAL

Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180. Group 1 will undergo an FNA at D-30 to D0. Participants will repeat the procedure at D14±5 and D30±5. Bone marrow sampling will be done for all groups at D730 and D1825.

Biological: Gardasil-9; Drug: Lidocaine injections

Group 2: Lymph node sampling at D60, D74 and D90

EXPERIMENTAL

Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180. Participants will undergo an FNA on the same day, but prior to, the second vaccine dose (D60±5; Visit 8) or up to 5 days before. Participants will repeat the procedure at Visit 8 + 14±5 days and Visit 8 + 30±5 days. Bone marrow sampling will be done for all groups at D730 and D1825.

Biological: Gardasil-9; Drug: Lidocaine injections

Group 3: Lymph node sampling at D180, D194 and D210

EXPERIMENTAL

Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180. Group 3 will undergo an FNA on the same day, but prior to, the third vaccine dose (D180±5; Visit 13) or up to 5 days before. Participants will repeat the procedure at Visit 13 + 14±5 days and Visit 13 + 30±5 days. Bone marrow sampling will be done for all groups at D730 and D1825.

Biological: Gardasil-9; Drug: Lidocaine injections

Interventions

Gardasil-9 BIOLOGICAL

Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180 The 9-valent HPV vaccine, or Gardasil-9, is a non-infectious recombinant vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. Gardasil-9 is supplied as a 0.5-mL single-dose vial or 0.5-mL single-dose prefilled Luer Lock syringe with tip cap.

Also known as: HPV vaccine

Group 1: Lymph node sampling at D-30 to D0, D14 and D30; Group 2: Lymph node sampling at D60, D74 and D90; Group 3: Lymph node sampling at D180, D194 and D210

Lidocaine injections DRUG

1-2% lidocaine injections. 1% lidocaine, an FDA approved local anesthetic, will be injected subcutaneously to numb the area of the lymph node being sampled; whereas 1-2% lidocaine will be injected into the tissue surrounding the area where the bone marrow will be removed. In adults the recommended dose is 7 mg/kg with a maximum of 500 mg.

Group 1: Lymph node sampling at D-30 to D0, D14 and D30; Group 2: Lymph node sampling at D60, D74 and D90; Group 3: Lymph node sampling at D180, D194 and D210

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals aged 18-45 years old (inclusive), as the HPV vaccine is approved for this age range in adults
• BMI ≤ 32.
• Able to understand and give informed consent (provided in American English).
• Must be in good health based on physical examination, vital signs, medical history, and the investigator's clinical judgment.
• Must be available and willing to participate for the duration of this study
• Must be willing to undergo lymph node fine needle aspiration and bone marrow aspiration
• Must be willing to consent to the future use of remaining (residual) samples/specimens.

You may not qualify if:

• Ever received a dose of an HPV vaccine
• HPV 6, 11, 16, 18, 31, 33, 45, 52 or 58 seropositivity
• Any history of genital warts, an abnormal pap smear, or positive HPV DNA test
• Has known allergy or history of anaphylaxis or other serious adverse reaction to a vaccine or vaccine products
• Has known allergy or history of anaphylaxis to yeast or products containing yeast
• Any allergy to lidocaine.
• Pregnancy or breast feeding.
• Subjects who believe they cannot tolerate the lymph node fine needle aspirate or bone marrow aspirate procedures without sedation
• Any history of lymphoma involving axillary nodes, any history of breast cancer, bilateral inflammatory process of upper arms in the past 2 weeks, prior breast or axillary biopsy and/or surgery that in the opinion of the investigator would affect the immune response results.
• Local infection, lymphadenitis, or rash in targeted area.
• Received any vaccine from 14 days before vaccine dose until 30 days after each vaccine dose.\*
• Volunteers with fever (≥100.4 F or 38°C regardless of the route) within 3 days prior to vaccination.\*
• History of or presence of severe co-morbidities as determined by the investigator, including autoimmune disease, or clinically significant cardiac, pulmonary, gastrointestinal, hepatic, rheumatologic, renal disease, thrombocytopenia, and grade 4 hypertension\*.
• \*Grade 4 hypertension per CTCAE criteria is defined as Life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit, hypertensive)
• History of a bleeding disorder or currently taking anti-coagulant products\* (e.g. warfarin, direct thrombin inhibitors, heparin products, etc.), anti-platelet products, and/or NSAIDs including aspirin.

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

The Hope Clinic of Emory University

Atlanta, Georgia, 30030, United States

Location

Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Interventions

Papillomavirus Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Dr. Erin Scherer
• Organization: Emory University

erin.margaret.scherer@emory.edu

404-712-6904

Study Officials

• Erin Scherer, Ph.D.

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 1, 2021
• Study Start: December 21, 2021
• Primary Completion: October 23, 2024
• Study Completion: May 1, 2026
• Last Updated: October 23, 2025
• Results First Posted: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: Available immediately following publication. No end date.
• Access Criteria: De-identified data will be published in an open access journal with no access restrictions; De-identified RNA Seq data will be deposited at NCBI/ Gene Expression Omnibus or similar public database with no access restrictions

Locations

US (2)