Phase 1 Endometrial Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with high-grade cervical cell changes (called CIN2 or CIN3), confirmed by a specialist examination and tissue sample.
• People whose cervical cell sample has tested positive for a specific strain of HPV called HPV16 (having other HPV types at the same time is still allowed).
• People aged 19 or older (this age requirement also reflects Alabama state law on consent).
• People with a life expectancy of more than 4 months.
• People who are generally able to carry out normal daily activities or light work (confirm with trial site what this means for individual circumstances).
• People whose blood test results, taken within 45 days of joining, show that their blood counts, liver function, and kidney function are all within acceptable ranges as defined by the trial.
• People who are willing and able to use two forms of contraception — including at least one barrier method (such as a condom, diaphragm, or cervical cap used with spermicide) — from before joining until 3 months after the trial ends, if there is any possibility of becoming pregnant.
• People who are able to understand the trial and are willing to sign a written consent form.
• People who are able to attend scheduled visits and follow the trial's requirements.

For the HIV-negative group specifically:

• People who have tested negative for HIV.

For the HIV-positive group specifically:

• People who have a confirmed HIV-positive diagnosis, documented by approved HIV testing methods.
• People whose HIV viral load (the amount of virus in the blood) has been recorded at 200 copies/mL or below on two separate tests, taken at least 24 hours apart, at an accredited laboratory.
• People who are willing to continue taking their prescribed antiretroviral (HIV) medications during the trial.

Who may not be able to join:

• People whose cervical cell changes have tested negative for HPV16.
• People in the HIV-positive group who have active, serious HIV-related illness that the investigator believes would make it difficult to take part in the trial.
• People in the HIV-positive group whose HIV viral load is above 200 copies/mL.
• People who have taken immune-suppressing medications for more than 14 days within the past 6 months (inhaled and topical steroids are generally allowed; confirm with trial site for specific medications).
• People with an active or ongoing hepatitis C or hepatitis B infection, as these could interfere with trial measurements.
• People who have previously received an investigational (not yet fully approved) HPV vaccine.
• People who have taken part in another experimental drug or treatment trial within the past 30 days.
• People with uncontrolled ongoing illness, such as an active serious infection, unstable heart problems, or a mental health or personal situation that would make it difficult to follow the trial requirements.
• People with a history of certain autoimmune diseases, such as lupus, celiac disease, autoimmune hepatitis, or multiple sclerosis (a history of thyroiditis, psoriasis, Sjögren's syndrome, or inflammatory bowel disease does not automatically exclude someone — confirm with trial site).
• People who are currently pregnant or breastfeeding, because the effect of the trial vaccine on a developing baby is not yet known.
• People who have had allergic reactions to substances that are chemically or biologically similar to the trial vaccine (confirm with trial site).
• People who have a metal implant at the planned injection site, or who have an electronic medical device such as a pacemaker, implantable defibrillator, nerve stimulator, or deep brain stimulator.
• People with any ongoing or significant neurological condition, including epilepsy or recurring seizures (a single childhood febrile seizure does not automatically exclude someone).
• People who have fainted within the past 12 months.
• People who have received immunoglobulins or blood products within the past 120 days, or who are expected to need them during the trial.
• People where the skin and tissue thickness at the planned injection site (the upper arm/deltoid area) measures more than 40 mm.
• People where the planned injection site on the upper arm cannot be clearly observed by the investigator due to a physical condition or permanent body art (such as a tattoo), in the investigator's judgment.
• People with significant ongoing problems with blood, lung, heart, liver, or kidney function, as determined by the investigator.
• People who have had a cancer diagnosis within the past 5 years (people who have had certain skin cancers — basal cell or squamous cell carcinoma — that were fully removed may still be eligible; confirm with trial site).
• People who are unable or unwilling to sign the informed consent form.

Important: Always verify eligibility with the trial site directly before applying.