drugset / Trial / NCT06799494

HPV Vaccine Reduced Dose

NCT06799494

Phase 4 Recruiting 100 enrolled Emory University Merck Sharp & Dohme LLC · collab
RandomizedParallel-groupOpen-labelBasic science

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.

Timeline

Start
2025-08-06
Primary completion
2028-09
Completion
2028-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Gardasil 9 Vaccine 0.5 ml Intramuscular
Background Lidocaine injection Unknown 1 % Subcutaneous
Background Lidocaine injection Unknown 2 % Subcutaneous
Background Lorazepam Small molecule Other