Is NCT06799494 recruiting in Decatur, GA?

Yes, NCT06799494 is currently recruiting participants at its Decatur, GA location. This hpv clinical trial is actively enrolling qualified participants.

How do I join the hpv clinical trial in Decatur?

To join this clinical trial in Decatur, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Decatur clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

HPV Clinical Trial in Decatur, GA

About This HPV Study in Decatur

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

Who Can Participate

Inclusion Criteria

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

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

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

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Decatur?

Yes, this clinical trial (NCT06799494) has an active research site in Decatur, GA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

HPV Treatment Options in Decatur, GA

If you're searching for hpv treatment options in Decatur, GA, this clinical trial (NCT06799494) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Decatur research site is actively enrolling participants for this phase 4 clinical trial. You'll receive care from experienced hpv specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hpv clinical trials near you to find additional studies recruiting in your area.

HPV Clinical Trial in Decatur, GA

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