Comparing the Antibody and B Cell Responses Induced by 1- or 2-dose 9-valent HPV (9vHPV) Vaccination in Healthy Adults

Status: Recruiting
Location: See location...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• 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

Locations
United States
Georgia
Hope Clinic of the Emory Vaccine Center
RECRUITING
Decatur
Contact Information
Primary
Erin Scherer, PhD
emscher@emory.edu
404-712-6904
Backup
Daniel Graciaa, MD
dsgraci@emory.edu
404-712-1370
Time Frame
Start Date: 2025-08-06
Estimated Completion Date: 2028-09
Participants
Target number of participants: 100
Treatments
Experimental: One dose of the 9-valent HPV vaccine
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.
Active_comparator: Two doses of the 9-valent HPV vaccine
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.
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: Emory University

This content was sourced from clinicaltrials.gov