RECRUITING

HPV Vaccine Reduced Dose

Conditions

HPV HPV Prevention HPV Vaccine Immune responses

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Comparing the Antibody and B Cell Responses Induced by 1- or 2-dose 9-valent HPV (9vHPV) Vaccination in Healthy Adults

Quick Facts

Study Start:2025-08-06

Study Completion:2028-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06799494

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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 * 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 the targeted area. * Received any vaccine from 14 days before the vaccine dose until 30 days after each vaccine dose\* (\An individual 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 participant continues to meet all other entry criteria) Volunteers with fever (≥100.4 F or 38°C regardless of the route) within 3 days before vaccination\. (\An individual 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 participant 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 participant continues to meet all other entry criteria) History of active malignancy other than squamous cell or basal cell skin cancer, unless there was a surgical excision considered to have achieved a cure. * Current and/or expected immunosuppression due to cancer, receipt of chemotherapy, radiation therapy, and other immunosuppressive therapies (including anti-TNF therapy). * 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) is allowed) * Known chronic infections including, but not limited to, 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 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 the first vaccine dose or plans to receive any experimental therapeutic agents 12 months after the first vaccine dose that, at the investigator's discretion, 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 this study. * Is currently participating or plans to participate in another clinical study that would involve the receipt of an investigational product or undergo a procedure that, in the investigator's opinion would interfere with the 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 investigator's discretion might interfere with compliance with the study.

Inclusion Criteria

Exclusion Criteria

* 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

* 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
* 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 the targeted area.
* Received any vaccine from 14 days before the vaccine dose until 30 days after each vaccine dose\* (\*An individual 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 participant continues to meet all other entry criteria)
* Volunteers with fever (≥100.4 F or 38°C regardless of the route) within 3 days before vaccination\*. (\*An individual 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 participant 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 participant continues to meet all other entry criteria)
* History of active malignancy other than squamous cell or basal cell skin cancer, unless there was a surgical excision considered to have achieved a cure.
* Current and/or expected immunosuppression due to cancer, receipt of chemotherapy, radiation therapy, and other immunosuppressive therapies (including anti-TNF therapy).
* 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) is allowed)
* Known chronic infections including, but not limited to, 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 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 the first vaccine dose or plans to receive any experimental therapeutic agents 12 months after the first vaccine dose that, at the investigator's discretion, 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 this study.
* Is currently participating or plans to participate in another clinical study that would involve the receipt of an investigational product or undergo a procedure that, in the investigator's opinion would interfere with the 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 investigator's discretion might interfere with compliance with the study.

Contacts and Locations

Study Contact

Erin Scherer, PhD

CONTACT

404-712-6904

emscher@emory.edu

Daniel Graciaa, MD

CONTACT

404-712-1370

dsgraci@emory.edu

Principal Investigator

Erin Scherer, PhD

PRINCIPAL_INVESTIGATOR

Emory University

Study Locations (Sites)

Hope Clinic of the Emory Vaccine Center

Decatur, Georgia, 30030

United States

Collaborators and Investigators

Sponsor: Emory University

Erin Scherer, PhD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-06

Study Completion Date2028-09

Study Record Updates