Assessing Durable Antibody Response to HPV Vaccination

Inclusion Criteria:

• Individuals aged 18-45 years old (inclusive), as the HPV vaccine is approved forthis age range in adults

• BMI ≤ 32.

• Able to understand and give informed consent (provided in American English).

• Must be in good health based on physical examination, vital signs, medical history,and the investigator's clinical judgment.

• Must be available and willing to participate for the duration of this study

• Must be willing to undergo lymph node fine needle aspiration and bone marrowaspiration

• Must be willing to consent to the future use of remaining (residual)samples/specimens.

Exclusion Criteria:

• 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

• Has known allergy or history of anaphylaxis or other serious adverse reaction to avaccine or vaccine products

• Has known allergy or history of anaphylaxis to yeast or products containing yeast

• Any allergy to lidocaine.

• Pregnancy or breast feeding.

• Subjects who believe they cannot tolerate the lymph node fine needle aspirate orbone marrow aspirate procedures without sedation

• Any history of lymphoma involving axillary nodes, any history of breast cancer,bilateral inflammatory process of upper arms in the past 2 weeks, prior breast oraxillary biopsy and/or surgery that in the opinion of the investigator would affectthe immune response results.

• Local infection, lymphadenitis, or rash in targeted area.

• Received any vaccine from 14 days before vaccine dose until 30 days after eachvaccine dose.*

*An individual who is initially excluded from study participation based on one ormore of the time-limited exclusion criteria (fever, receipt of other vaccines) maybe reconsidered for enrollment once the condition has resolved as long as thesubject continues to meet all other entry criteria.

• Volunteers with fever (≥100.4 F or 38°C regardless of the route) within 3 days priorto vaccination.*

*An individual who is initially excluded from study participation based on one ormore of the time-limited exclusion criteria (fever, receipt of other vaccines) maybe reconsidered for enrollment once the condition has resolved as long as thesubject continues to meet all other entry criteria.

• History of or presence of severe co-morbidities as determined by the investigator,including autoimmune disease, or clinically significant cardiac, pulmonary,gastrointestinal, hepatic, rheumatologic, renal disease, thrombocytopenia, and grade 4 hypertension*.

*Grade 4 hypertension per CTCAE criteria is defined as Life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit,hypertensive)

• History of a bleeding disorder or currently taking anti-coagulant products* (e.g.warfarin, direct thrombin inhibitors, heparin products, etc.), anti-plateletproducts, and/or NSAIDs including aspirin.

*including in the past week; however, an individual who is initially excluded fromstudy participation based on one or more of the time-limited exclusion criteria maybe reconsidered for enrollment once the condition has resolved as long as thesubject continues to meet all other entry criteria

• Has history of active malignancy other than squamous cell or basal cell skin cancer,unless there has been surgical excision that is considered to have achieved cure.

• Current and/or expected immunosuppression due to cancer, receipt of chemotherapy,radiation therapy, and any other immunosuppressive therapies (including anti-TNFtherapy).

• Has known or suspected congenital or acquired immunodeficiency, including functionalor anatomic asplenia, or recent history or current use of immunosuppressivetherapy*.

*Anti-cancer chemotherapy or radiation therapy within the preceding 3 years, orlong-term (≥2 weeks within the previous 3 months) systemic corticosteroid therapy (e.g., prednisone at a dosage of ≥20 mg per day or on alternative days). Intranasalor topical prednisone (or equivalent) are allowed.

• Known chronic infections including, but not limited to, known HIV, tuberculosis,hepatitis B or C.

• Is post-organ, bone marrow, and/or stem cell transplant, whether or not on chronicimmunosuppressive therapy.

• Received blood products or immunoglobulin in the 3 months before study entry orplanned use during this study.

• Had major surgery (per the investigator's judgment) within 4 weeks before studyentry or planned major surgery during this study.

• Insulin-dependent diabetes* mellitus type 1 or type 2 requiring therapy

*History of isolated gestational diabetes is not an exclusion criterion.

• Received experimental therapeutic agents within 12 months before first vaccine doseor plans to receive any experimental therapeutic agents 12 months after firstvaccine dose that, in the opinion of the investigator, would interfere with thesafety or objectives of the study. COVID-19 vaccines that fall under FDA EUA will betreated as approved vaccines for the purposes of this study.

• Is currently participating or plans to participate in another clinical study whichwould involve receipt of an investigational product or undergo a procedure that, inthe opinion of the investigator, would interfere with safety or objectives of thestudy.

• Current diagnosed or self-reported alcohol abuse, drug abuse, or psychiatricconditions that in the opinion of the investigator would preclude compliance withthe study.

• Social, occupational, or any other condition that in the opinion of the investigatormight interfere with compliance with the study.