HPV Vaccine for Human Papillomavirus

Recruiting in Palo Alto (17 mi)

Overseen byErin Scherer, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Emory University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for healthy adults aged 18-45 who haven't had the HPV vaccine or past HPV infections. Participants should not have antibodies against certain HPV types, a history of genital warts, abnormal pap tests, or positive HPV DNA tests. They must also be able to undergo study procedures without contraindications.

Inclusion Criteria

I am willing to delay finishing my 9vHPV vaccine series.

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

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Exclusion Criteria

I have not received blood products or immunoglobulin in the last 3 months.

I have received an HPV vaccine dose.

I am currently immunosuppressed due to cancer treatment.

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Treatment Details

Interventions

Gardasil-9 (Cancer Vaccine)

Trial OverviewThe study compares immune responses in individuals given one dose of the Gardasil-9 vaccine versus those receiving two or three doses. It will measure antibody levels in blood, lymph nodes, and bone marrow to assess if a single dose can provide similar protection.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: One dose of the 9-valent HPV vaccineExperimental Treatment3 Interventions

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.

Group II: Two doses of the 9-valent HPV vaccineActive Control3 Interventions

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.