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HPV Vaccine Reduced Dose

StatusRecruiting
PhasePhase 4
Started2025-08-06
View on ClinicalTrials.gov ↗

Amendment history

2026-08-28
Study Identification, Study Status, Sponsor/Collaborators, Arms and Interventions, Eligibility v5
Eligibility criteria+6 characters
Inclusion Criteria: Individuals aged 18-45 years old (inclusive), as the HPV vaccine is approved for this age range in adults BMI ≤< 3235 Able to understand and give informed consent (in American E [...] he duration of this study Willing to undergo lymph node fine-needle aspiration and bone marrow aspiration Willing to cons [...] d 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 papPap smear, or a positive HPV DNA test Known allergy or history of anaphylax [...] 2 weeks, prior breast or axillary biopsy and/or surgery that, in the opinion of [...] [...]
2025-08-19
Study Status v4
Re-verified, no change to tracked fields
2025-08-06
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2028-05→2028-09
Completion date2028-05→2028-09
Start date2025-05→2025-08-06
Study sitesdetails revised at 1 of 1 site
2025-04-30
Study Status v2
Primary completion date2028-03→2028-05
Completion date2028-03→2028-05
Start date2025-03→2025-05
2025-02-28
Study Status v1
Start date2025-02→2025-03
2025-01-23
Original filing
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.
Trial Details
NCT Number NCT06799494
Lead Sponsor Emory University
Collaborators: Merck Sharp & Dohme LLC
Conditions HPV
Enrollment 100 participants
Start Date 2025-08-06
Primary Completion 2028-09 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-31