HPV vaccine in healthy donors could help fight cancer
NCT ID NCT06508138
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests an HPV vaccine series in healthy relatives of patients with advanced HPV-related cancer. The goal is to generate HPV-specific white blood cells that can be collected and used in a bone marrow transplant or donor lymphocyte infusion for the patient. The study focuses on safety and immune response in the donors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HPV vaccine series (pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine and TA-HPV vaccinia virus)
- What this could lead to
- If successful, this approach could help treat patients with advanced HPV-related cancers by using vaccinated donor immune cells.
- What could go wrong
- This is a very early phase 1 trial with only 24 healthy donors, so safety and immune response are still being tested. The linked recipient trial is also early, and the treatment may not work or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * HLA-haploidentical relative of a patient with advanced HPV 16-associated malignancy * Female or male subjects age 18-70 years of age with a BMI ≥ 18.5 kg/m2. * Subjects must understand and agree to comply with the requirements of the study by signing an Informed Consent Form (ICF) indicating voluntary consent to participate in the study prior to the initiation of Screening or study-related activities. * Able and willing to comply with all study procedures. * Must meet at least one of the following three criteria with respect to reproductive capacity: 1. Post-menopausal as defined by absence of or missed menstruation after normal menstrual cycle for ≥ 12 months; 2. Surgically sterile or have a partner who is sterile (i.e., vasectomy in males or absence of ovaries and/or uterus in females); 3. Use of medically effective contraception with a failure rate of less than 1% per year when used consistently and correctly from screening until 3 months following last dose. (Acceptable methods include hormonal contraception (including implants or combined oral + injected); two barrier methods (e.g., condom with spermicide and cervical cap); or abstinence when this is the subject's preferred and usual lifestyle. * Medically healthy with no clinically significant findings in the physical examination, medical history, vital signs. * Normal screening ECG or screening ECG with no clinically significant findings as judged by the Investigator. * No history of any clinically significant immunosuppressive or autoimmune disease including hematologic malignancy or history of solid organ or bone marrow transplantation * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * White blood cell count ≥ 3,000 * Lymphocyte number ≥ 500 * Absolute neutrophil count ≥ 1,000 * Platelets ≥ 90,000 * Hemoglobin ≥ 9 * Total bilirubin \< 1.5 x upper limit of normal (ULN) (\< 3 x ULN if Gilbert's disease) * Cardiac Troponin \< 0.04 ng/mL * AST(SGOT)/ALT(SGPT) \< 3 x ULN * Creatinine \< 1.5 x ULN or estimated creatinine * clearance ≥ 60 mL/min per Modified * Cockroft-Gault Formula Exclusion Criteria: * Prior vaccination with any HPV antigen (prophylactic or therapeutic) except L1. Individuals who have been immunized with licensed prophylactic HPV vaccines (e.g. Gardasil®, Cervarix®) are not excluded. * Subjects who have had chemotherapy, radiation, biological cancer therapy, or other investigational. * Subjects who have had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.). * History of myocarditis or pericarditis, or other known underlying heart disease (e.g., cardiomyopathy, congestive heart failure, symptomatic arrhythmia not controlled by medication, unstable angina, history of acute myocardial infarction or cerebrovascular accident within the past 6 months) * Subjects with an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection/sepsis, or psychiatric illness/social situations that would limit compliance with study requirements. * A history of current or recent concurrent malignancy (≤ 5 years) except nonmelanoma skin cancer. * Subjects with active or chronic infection of HIV, HCV, or HBV. * Subjects who have an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), ankylosing spondylitis) with immunodeficiency as a clinical component. * Subjects treated with immunosuppressive drugs such as cyclosporine, adrenocorticotropic hormone (ACTH), alkylating agents, antimetabolites, radiation, Tumor Necrosis Factor (TNF) inhibitors, or systemic corticosteroids, either chronically or in the past 2 months * Subjects with a recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have acquired, hereditary, or congenital immunodeficiencies. * Subjects and the subject's close social, sexual, or domestic contacts may not have no-nhealed wounds or active exfoliative skin conditions such as: Eczema, Burns, Impetigo, Varicella-zoster virus infection, Herpes simplex virus infection, Severe acne, Severe diaper dermatitis with extensive areas of denuded skin, Psoriasis, Lichen planus, Darier disease (keratosis follicularis) * History or presence of atopic dermatitis * Conditions associated with immunosuppression such as HIV/AIDS, leukemia, lymphoma, generalized malignancy, solid organ transplant or hematopoietic stem cell transplant recipients * Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements or assessment of immunologic endpoints. * Prisoners or subjects who are compulsorily detained (involuntary incarceration) for treatment of either a physical or psychiatric illness. * Any illness or condition that in the opinion of the investigator may affect the safety of the subject or the evaluation of any study endpoint. * Women of child-bearing potential who are not on any form of birth control will be excluded. * Breast feeding * No close social contact with children under 5 years old or close social or domestic contact with a pregnant woman * Serious vaccine component allergy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287, United States
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Other studies related to the condition(s) this trial covers.
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