Assessing Durable Antibody Response to HPV Vaccination

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single center, longitudinal cohort study in which subjects will receive 9-valent HPV vaccine according to package insert (i.e., one dose of 9-valent HPV vaccine on day (D) 0 followed by a second dose 2 months later and a third dose 6 months later).

Immune responses in the blood, saliva, bone marrow, and lymph nodes will be assessed in subjects receiving the HPV vaccine.

Blood samples for immunologic testing will be collected at screening (from D-60 to D-7), on D0 (before vaccination), D1, D7, D14, D30, D60 (before vaccination), D61, D67, D74, D90, D180 (before vaccination), D187, D194, D210, D365, and D730. Saliva samples for antibody testing will be collected on D0 (before vaccination), D30, D60 (before vaccination), D90, D180 (before vaccination), D210, D365, and D730.

Axillary lymph node sampling by fine needle aspiration will be done in all groups at D-30 and 2 additional times in per group. Group 1 will have lymph node sampling done D14 and D30 after the first dose. Group 2 will have lymph node sampling done D74 and D90. Group 3 will have lymph node sampling D194 and D210. Bone marrow sampling will be done for all groups at D730.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emory University
• Treatments: Lidocaine

Criteria

Inclusion Criteria:

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

• BMI ≤ 32.

• Platelets ≥ 150,000/mm3 (if available by medical records in the past month).

• INR < 1.2 (if available by medical records in the past month).

• 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 marrow aspiration

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

• Screening labs (WBC, Hemoglobin, platelets, PT, PTT) within institutional limits for subjects undergoing bone marrow aspiration and completed within 30 days of bone marrow aspiration visit.

• Vital signs parameters acceptable for BM aspiration procedures (if outside the following ranges, vital signs can be repeated once at the investigator discretion):

• Heart rate 55-100

• Blood pressure systolic 90-150

• Temperature <100.0 F

• Respiratory rate 12-18

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 a vaccine 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 or bone 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 or axillary biopsy and/or surgery that in the opinion of the investigator would affect the immune response results.

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

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

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

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

*An individual who is initially excluded from study participation based on one or more of the time-limited exclusion criteria (fever, receipt of other vaccines) may be reconsidered for enrollment once the condition has resolved as long as the subject 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-platelet products, and/or NSAIDs including aspirin.

*including in the past week; however, an individual who is initially excluded from study participation based on one or more of the time-limited exclusion criteria may be reconsidered for enrollment once the condition has resolved as long as the subject 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-TNF therapy).

• Has known or suspected congenital or acquired immunodeficiency, including functional or anatomic asplenia, or recent history or current use of immunosuppressive therapy*.

*Anti-cancer chemotherapy or radiation therapy within the preceding 3 years, or long-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). Intranasal or 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 chronic immunosuppressive therapy.

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

• Had major surgery (per the investigator's judgment) within 4 weeks before study entry 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 dose or plans to receive any experimental therapeutic agents 12 months after first vaccine dose that, in the opinion of the investigator, would interfere with the safety or objectives of the study. COVID-19 vaccines that fall under FDA EUA will be treated as approved vaccines for the purposes of this study.

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

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

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