Actively Recruiting
HPV Vaccine Reduced Dose
Led by Emory University · Updated on 2025-08-20
100
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
HPV Vaccine Reduced Dose
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged 18-45 years old (inclusive)
- Body mass index (BMI) less than or equal to 32
- Able to understand and provide informed consent in American English
- In good health based on physical exam, vital signs, medical history, and clinical judgment
- Available and willing to participate for the full study duration
- Willing to undergo lymph node fine needle aspiration and bone marrow aspiration
- Willing to consent to future use of remaining samples with IRB review
- Willing to delay completion of the recommended 9-valent HPV vaccine series
You will not qualify if you...
- Previously received any HPV vaccine dose
- Positive antibodies for HPV types 6, 11, 16, 18, 31, 33, 45, 52, or 58
- History of genital warts, abnormal pap smear, or positive HPV DNA test
- Known allergy or serious reaction to vaccines or vaccine components
- Allergy to yeast or yeast-containing products
- Allergy to lidocaine
- Pregnant or breastfeeding
- Unable to tolerate lymph node or bone marrow aspiration without general sedation
- History of lymphoma involving axillary nodes or breast cancer
- Recent breast or axillary biopsy or surgery affecting immune results
- Local infection, lymphadenitis, or rash in the biopsy area
- Received any vaccine 14 days before or 30 days after study vaccine dose
- Fever of 100.4°F (38°C) or higher within 3 days before vaccination
- Severe co-morbidities including autoimmune disease, cardiac, pulmonary, gastrointestinal, hepatic, rheumatologic, renal disease, thrombocytopenia, or grade 4 hypertension
- History of bleeding disorders or use of blood thinners and NSAIDs including aspirin within the past week
- History of active cancer except cured skin cancers
- Current or expected immunosuppression due to cancer or therapies
- Known or suspected immunodeficiency or recent immunosuppressive therapy
- Chronic infections such as HIV, tuberculosis, hepatitis B or C
- Post-organ, bone marrow, or stem cell transplant
- Received blood products or immunoglobulin within 3 months prior or planned during study
- Major surgery within 4 weeks before study or planned during study
- Insulin-dependent diabetes mellitus requiring therapy
- Received experimental therapies within 12 months before or planned 12 months after study
- Participation in other clinical studies that interfere with safety or objectives
- Alcohol or drug abuse or psychiatric conditions interfering with compliance
- Social or occupational conditions interfering with study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hope Clinic of the Emory Vaccine Center
Decatur, Georgia, United States, 30030
Actively Recruiting
Research Team
E
Erin Scherer, PhD
CONTACT
D
Daniel Graciaa, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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