HPV Vaccine Reduced Dose
Eligible age
18–45 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
See if you qualify for this study
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About this study
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.
Sponsor: Emory University
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
Where it's recruiting
Decatur
Source: ClinicalTrials.gov · NCT06799494 · last updated 2025-08-20