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Understanding Severe HPV-Related Diseases (Neptune Study)

This study, called Neptune, aims to understand why some people get severe human papillomavirus (HPV) related diseases that are hard to treat. While most HPV infections don't cause serious problems, some can lead to growths, warts, or tumors that don't respond well to medicine or surgery. Researchers want to find out what makes certain individuals more likely to develop these severe forms of HPV disease and why treatments aren't always effective for them. The study is looking for people aged 3 and older who have had many outbreaks of HPV-related warts or lesions that haven't responded to treatment. Healthy family members are also needed. The main goal is to identify new immune system factors or genetic traits that make someone more susceptible to these severe HPV-related conditions.

Study design
This is an observational study, meaning no specific treatments are being tested. It is a prospective, longitudinal natural history study, planning to enroll 850 participants.
What's involved
Participants will undergo a medical history review, a physical exam, and blood tests. Individual participation in the study will last for 10 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed throughout the 10-year study period to identify immune and genetic factors.

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NCT05026138

Natural History, Epidemiology and Pathogenesis of Severe HPV-Related Diseases (Neptune)

Recruiting
Not specifiedAges 3+Observational
National Institute of Allergy and Infectious Diseases (NIAID)
~850 participants
Updated 2026-07-06 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Identify novel immunologic and/or genetic determinants of the susceptibility to severe disseminated, recurrent, and treatment-refractory HPV-related diseases.
Measured over Throughout the study

Conditions

Human Papillomavirus

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Human Papillomavirus InfectionSquamous Cell CarcinomaCD4 GeneHIV Infection

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Andrea Lisco, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Allergy and Infectious Diseases (NIAID)

Who to contact

Andrea Lisco, M.D.
[email protected]
(301) 761-7122
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

The lack of complete response to 2 or more interventions is defined as treatment-refractory disease in the protocol, while the reappearance of a skin or mucosal lesion after complete resolution is defined as recurrence.

What this trial measures

  • Identify novel immunologic and/or genetic determinants of the susceptibility to severe disseminated, recurrent, and treatment-refractory HPV-related diseases.Throughout the study

    To define the clinical, immunologic, and genetic bases of severe disseminated, recurrent, and treatment-refractory HPV-related skin and mucosal disease.