NCT06508138
Clinical Trial Assessing the Safety and Immunologic Correlates of Heterologous Prime-Boost With pNGVL4a-Sig/E7(Detox)/HSP70 and TA-HPV in Healthy Donors Followed by Peripheral Blood Collection
Enrolling by Invitation
PHASE1Ages 18–70InterventionalSidney Kimmel Comprehensive Cancer Center at Johns HopkinsInvestigator-initiated
~24 participants
Updated 2026-03-06 on ClinicalTrials.gov
What's tested:pNGVL4a-Sig/E7(detox)/HSP70 plasmid DNA; TA-HPV vaccinia virus
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of Vaccine series as assessed by number of adverse events
Measured over 3 months
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Philip Imus, MD · PRINCIPAL_INVESTIGATOR · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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:
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
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
What this trial measures
- Safety of Vaccine series as assessed by number of adverse events3 months
Safety of the vaccine series will be assessed by counting number of adverse events