HPV Vaccine Reduced Dose

NCT06799494 | Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY00008623
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to answer the question: does 1-dose HPV vaccination generate the same immune responses compared to 2- or 3-dose HPV vaccination? This will be done by studying the immune response in blood, lymph nodes, and bone marrow. Human papillomaviruses (HPV) cause cancers (cervical, anal, oropharyngeal, vulvar, vaginal, and penile), and the current HPV vaccine is highly effective at preventing disease by HPV types that cause 90% of cancer cases. While this vaccine generates high levels of antibodies that last for \> 10 years, understanding of how this occurs is limited, and studying this immune response will help design new and better vaccines. The study population consists of healthy adult (age 18-45) participants who have not previously received an HPV vaccine, do not have antibodies against certain types of HPV, do not have a history of HPV infection or disease (such as genital warts, abnormal pap test, or HPV DNA test), and do not have contraindications to study procedures. Populations of increased concern are not being enrolled.

Conditions

HPV

Keywords

HPV Prevention; HPV Vaccine; Immune responses

Outcome Measures

Primary Outcomes (1)

• Frequency of plasma cells specific for HPV16/18 virus like particles (VLPs)

  Frequency of plasma cells specific for HPV16/18 virus-like particles (VLPs) per total IgG-secreting plasma cells in bone marrow in per-protocol participants of the 1- and 2-dose 9vHPV arms

  730 days after receiving the first vaccine dose

Secondary Outcomes (1)

• Frequency of memory B cells specific for HPV16/18 VLPs

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

Study Arms (2)

One dose of the 9-valent HPV vaccine

EXPERIMENTAL

Participants will receive one dose of the 9-valent HPV (9vHPV) vaccine by intramuscular injection on Day 0. Participants will be asked to donate blood samples for immunologic testing at screening (from Day -60 to -1), on Day 0 (before vaccination), 7±1, 30±5, 180±5 (before vaccination; Visit 5), Visit 5 + 7±1 days, Visit 5 + 30±5 days, 365±14, 730±14, 1095±14, 1460±14, 1825±30 (Visit 15), and ≥84 days from Visit 15 (Optional Visit 17). Axillary lymph node sampling by fine needle aspiration (FNA) will be done 3 times per group on Day 30±5, 180±5 (Visit 5), Visit 5 + 30±5 days. Bone marrow sampling will be done for all groups at Days 730±14 and 1825±30.

Biological: Gardasil-9; Drug: Lidocaine injection; Drug: Lorazepam

Two doses of the 9-valent HPV vaccine

ACTIVE COMPARATOR

Participants will receive two doses of the 9vHPV vaccine on Day 0 and a second dose 6 months later. Participants will be asked to donate blood samples for immunologic testing at screening (from Day -60 to -1), on Day 0 (before vaccination), 7±1, 30±5, 180±5 (before vaccination; Visit 5), Visit 5 + 7±1 days, Visit 5 + 30±5 days, 365±14, 730±14, 1095±14, 1460±14, 1825±30 (Visit 15), and ≥84 days from Visit 15 (Optional Visit 17). Axillary lymph node sampling by fine needle aspiration (FNA) will be done 3 times per group on Day 30±5, 180±5 (Visit 5), Visit 5 + 30±5 days. Bone marrow sampling will be done for all groups at Days 730±14 and 1825±30.

Biological: Gardasil-9; Drug: Lidocaine injection; Drug: Lorazepam

Interventions

Gardasil-9 BIOLOGICAL

The 9-valent HPV VLP vaccine is a sterile liquid suspension prepared by combining the adsorbed VLPs of each HPV type and additional amounts of the aluminum-containing adjuvant and the final purification buffer. The 9-valent HPV vaccine, or Gardasil-9, is a sterile suspension for intramuscular administration. Each 0.5-mL dose of the vaccine also contains approximately 500 mcg of aluminum (provided as AAHS), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium borate, \<7 mcg yeast protein, and water for injection. The product does not contain a preservative or antibiotics. 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. After thorough agitation, GARDASIL 9 is a white, cloudy liquid.

Also known as: HPV Vaccine, 9-valent HPV vaccine (9vHPV)

One dose of the 9-valent HPV vaccine; Two doses of the 9-valent HPV vaccine

Lidocaine injection DRUG

Lidocaine 1% will be injected intradermally and subcutaneously into the margin of the lymph node to be sampled to numb the area. To confer local anesthesia, 1-2% will be injected into the tissue surrounding the area where the bone marrow will be removed.

Also known as: Lidocaine 1% Injectable Solution

One dose of the 9-valent HPV vaccine; Two doses of the 9-valent HPV vaccine

Lorazepam DRUG

Lorazepam, an FDA-approved benzodiazepine, will be administered as an anxiolytic before the bone marrow aspirate procedure per the clinician who will perform the procedure. If needed, lorazepam will be administered sublingually per manufacturer dosing recommendations.

One dose of the 9-valent HPV vaccine; Two doses of the 9-valent HPV vaccine

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 (in American English).
• In good health based on physical examination, vital signs, medical history, and the investigator's clinical judgment.
• Available and willing to participate for the duration of this study
• Willing to undergo lymph node fine needle aspiration and bone marrow aspiration
• Willing to consent to the future use of remaining (residual) samples/specimens with IRB review
• Willing to defer completion of the recommended 9vHPV series

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
• Known allergy or history of anaphylaxis or other serious adverse reaction to a vaccine or vaccine products
• Known allergy or history of anaphylaxis to yeast or products containing yeast.
• Any allergy to lidocaine.
• Pregnancy or breastfeeding.
• Participants who believe they cannot tolerate the lymph node fine needle aspirate or bone marrow aspirate procedures without general 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 the targeted area.
• 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 active malignancy other than squamous cell or basal cell skin cancer, unless there was a surgical excision considered to have achieved a cure.
• Current and/or expected immunosuppression due to cancer, receipt of chemotherapy, radiation therapy, and other immunosuppressive therapies (including anti-TNF therapy).
• Known or suspected congenital or acquired immunodeficiency, including functional or anatomic asplenia, or recent history or current use of immunosuppressive therapy\*\*\*\*. (\*\*\*\*Anti-cancer chemotherapy or radiation therapy within the preceding 3 years, or long-term (≥2 weeks within the previous 3 months) systemic corticosteroid therapy (e.g., prednisone at a dosage of ≥20 mg per day or on alternative days). Intranasal or topical prednisone (or equivalent) is allowed)
• Known chronic infections including, but not limited to, HIV, tuberculosis, hepatitis B or C.

Sponsors & Collaborators

• Emory University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Hope Clinic of the Emory Vaccine Center

Decatur, Georgia, 30030, United States

RECRUITING

MeSH Terms

Interventions

Papillomavirus Vaccines; Lidocaine; Lorazepam

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Erin Scherer, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Scherer, PhD

CONTACT

404-712-6904; emscher@emory.edu

Daniel Graciaa, MD

CONTACT

404-712-1370; dsgraci@emory.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: 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: January 23, 2025
• First Posted: January 29, 2025
• Study Start: August 6, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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 public repositories with no access restrictions.

Locations

US (1)