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HPV 16 InfectionPhase 1J21112LINKEDNCT06508138

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

A Phase 1 study testing pNGVL4a-Sig/E7(detox)/HSP70 plasmid DNA; TA-HPV vaccinia virus in people with HPV 16 Infection and HPV-Related Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This healthy related donor clinical trial is linked to a recipient clinical trial protocol for therapeutic purposes. In this healthy donor protocol, haploidentical relatives of a patient with recurrent or metastatic human papilloma virus (R/M HPV) 16-associated malignancy will be invited to be vaccinated with a… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
What is being tested?
pNGVL4a-Sig/E7(detox)/HSP70 plasmid DNA; TA-HPV vaccinia virus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
18 Oct 2023to 18 Oct 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
  • Post-menopausal as defined by absence of or missed menstruation after normal menstrual cycle for ≥ 12 months;
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  • Surgically sterile or have a partner who is sterile (i.e., vasectomy in males or absence of ovaries and/or uterus in females);
  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: A Phase I 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

This healthy related donor clinical trial is linked to a recipient clinical trial protocol for therapeutic purposes. In this healthy donor protocol, haploidentical relatives of a patient with recurrent or metastatic human papilloma virus (R/M HPV) 16-associated malignancy will be invited to be vaccinated with a therapeutic HPV vaccine series (PVX1) to generate HPV-specific white blood cells. In the linked recipient phase 1 clinical trial protocol, patient with incurable, locally recurrent or metastatic HPV 16-associated head and neck cancer will be randomized to one of two arms:

Arm A: non-myeloablative (NMA) allogeneic bone marrow transplant (alloBMT) OR Arm B: CD8-depleted donor lymphocyte infusion (DLI) on Day 0 of a dose escalation scheme

These two clinical trials are separated so that the healthy donor trial deals exclusively with issues of safety and immunological efficacy of the HPV vaccine series and this companion recipient trial examines the safety, feasibility and clinically efficacy of the allogeneic bone marrow graft and CD8-depleted DLI. The central hypothesis of the clinical trial is that patients with R/M HPV-associated malignancies can be safely and effectively treated by allogeneic bone marrow transplantation and/or CD8-depleted DLI from a healthy related donor that has been vaccinated against HPV16 E6 and E7 proteins.

Read the detailed description

Scientists have found that a family of viruses called the Human Papillomavirus (HPV) can cause certain cancers, particularly in the head and neck and cervix. Most of these cancers are caused by a specific type of HPV called HPV16. This research is being done to see if giving an investigational vaccine against HPV causes the participant's immune system to respond against proteins that are made by the vaccine and by the cancer in the participant's relative. The investigators would like to see if cells of the immune system that have responded to the vaccine can be found in the participant's blood. In a separate study the investigators will test if the blood and immune cells from the participant's blood can be given safely to the participant's relative and if the participant's cells cause the cancer in the participant's relative to shrink.

The first two shots the participant would be given are a vaccine called "pNGVL4a-Sig/E7 (detox)/HSP70", and it contains DNA, the blueprint for making proteins. This vaccine is given as a shot into a muscle either in the shoulder or in the thigh. This will be followed by a third shot called "TA-HPV" which contains a vaccinia virus that helps the first shot to work by creating the T cells needed to fight cancer. After receiving the vaccines, the study team will collect the participant's immune system cells to give to the participant's relative with cancer. The collection will either be by bone marrow harvest or collection of the participant's circulating blood, depending on the group to which the participant and the participant's relative are randomized after enrolling in the trial.

The use of this heterogeneous vaccination strategy in this research study is investigational, which means that the vaccine regimen is not approved for marketing by the Food and Drug Administration (FDA). The FDA is allowing the use of the vaccine regimen in this study. Based on prior clinical studies, it is expected that this vaccine regimen and routes of administration will be well tolerated.

In this research the investigators will also be collecting blood samples that may also be used in the future by researchers.

Being tested
pNGVL4a-Sig/E7(detox)/HSP70 plasmid DNA; TA-HPV vaccinia virus
Keywords
HPV, Papivax, Seiwert, non myeloablative allogeneic bone marrow transplant, alloBMT, HPV16, J21112, J2199
Medical subject headings
Recurrence, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pNGVL4a-Sig/E7(detox)/HSP70 plasmid DNA; TA-HPV vaccinia virusBiological

    Also called PVX1

    About 1 month before donating blood, donors are required to come to outpatient clinic once a week to receive the following vaccine series:

    Week 1: PVX1 (1 of 3): intramuscular injection (IM) of 3mg DNA prime with pNGVL4a-Sig/E7(detox)/HSP70 vaccine Week 2: PVX1 (2 of 3): IM 3mg DNA prime with pNGVL4a-Sig/E7(detox)/HSP70 vaccine Week 3: PVX1 (3 of 3): IM TA-HPV vaccinia boost Pause for 2 weeks Peripheral blood collection and possible bone marrow harvest depending on randomization

Study groups in NCT06508138
Study groupRoleWhat they receive
Blood and Bone Marrow Donation for Recipient Patient's alloBMTActive comparatorDonor patients receive the vaccination series. This will be followed by a bone marrow harvest under anesthesia that will be given to the donor's related recipient patient on the J21112 study. Then, depending on recipient response to allogeneic BMT, donor may return for collection of peripheral blood used to create CD8-depleted donor lymphocyte infusion (DLI) which will be given to the donor's related recipient patient on D90.
Receives: Biological: pNGVL4a-Sig/E7(detox)/HSP70 plasmid DNA; TA-HPV vaccinia virus
Blood Donation Only for Recipient's CD-8 Depleted DLIActive comparatorDonor patients receive the vaccination series followed by collection of peripheral blood. This blood will be used to create the CD8-depleted donor lymphocyte infusion (DLI) which will be given to the donor's related recipient patient on the J21112 study.
Receives: Biological: pNGVL4a-Sig/E7(detox)/HSP70 plasmid DNA; TA-HPV vaccinia virus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of Vaccine series as assessed by number of adverse events

    Safety of the vaccine series will be assessed by counting number of adverse events

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2024
  2. Study start18 Oct 2023
  3. Primary completion18 Apr 2027 (estimated)
  4. Study completion18 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized to one of two groups: Arm A: Donors on this arm of the study will donate cells and bone marrow to the paired recipient (who will receive a standard allogeneic stem cell transplant, Cytoxan, and may receive HPV-specific donor lymphocyte cell infusion (DLI) at Day 90, depending on the donor's response). Arm B: Donors on this arm of the study will donate cells to the donor's paired recipient (who will receive Cytoxan followed by HPV-specific DLI).
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06508138
Sponsor's protocol ID
J2199
Other IDs
IRB00243952
Acronym
J21112LINKED
Status last verified
Mar 2026
First submitted
24 Jun 2024
Last updated
6 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing pNGVL4a-Sig/E7(detox)/HSP70 plasmid DNA; TA-HPV vaccinia virus in people with HPV 16 Infection and HPV-Related Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of Vaccine series as assessed by number of adverse events (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06508138.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.

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