A Phase 1/2 interventional study of pBI-4 Vaccine in Cervical Intraepithelial Neoplasia Grade 1 and Human Papillomavirus 16 Infection, sponsored by Chang Gung Memorial Hospital. Not yet recruiting at 2 sites in Taiwan. Open to female participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Chang Gung Memorial Hospital · Phase 1/2, Interventional, and Treatment
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Among 10 studies in Uterine Cervical Dysplasia with a site in Taiwan — 4 open to participants now, 5 under way, none of them phase 3. Uterine Cervical Dysplasia · Taiwan.
Among the 10 studies in Uterine Cervical Dysplasia with a site in Taiwan, this one is one of 3 that started in 2026, is the only one in phase 1/2, and was the 10th registered.
409 studies on the registry are indexed under Uterine Cervical Dysplasia; 76 are open to participants now.
Browse Uterine Cervical Dysplasia studies →4 of the 10 studies in Uterine Cervical Dysplasia with a site in Taiwan are open now. Recruiting first, the newest first:
PapiVax Biotech, Inc. · Sites in Taiwan, United States
Ages 18–60 · Women only
Chang Gung Memorial Hospital · Sites in Taiwan
Ages 20+ · Women only
Far Eastern Memorial Hospital · Sites in Taiwan
Women only · Healthy volunteers
A study can be open while its sites in Taiwan have not opened yet or have stopped. Only those recruiting at a site in Taiwan →
Of the 43 Uterine Cervical Dysplasia studies recruiting now, 19 (44%) set no upper age limit and 21 (49%) stop at 75 or younger; 3 take children under 18; 11 take healthy volunteers.
This study: 19 Years to 65 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2 · Phase 3 1
First in 2005; this study’s year is marked. 3 started in 2026.
This study's planned enrollment of 94 is below the median of 167 across 285 interventional studies indexed under Uterine Cervical Dysplasia.
Median enrollment 292 across the 6 interventional studies, 425 across the 4 observational. Of the 3 that completed or were terminated, 1 (33%) have results posted.
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2 of 10 have an industry lead sponsor. The 8 most frequent:
Chang Gung Memorial Hospital is the lead sponsor of 1,096 studies on the registry; 239 are open to participants now.
Chang Gung Memorial Hospital has 3 studies filed under Uterine Cervical Dysplasia — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Uterine Cervical Dysplasia with a site in Taiwan, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate the safety, efficacy, and tolerability of pBI-4, an investigational therapeutic DNA vaccine, in treating adult women with Human Papillomavirus type 16 (HPV16)-positive Grade 1 cervical intraepithelial neoplasia (CIN1) or persistent HPV16 infection.
This is a randomized, double-blind, placebo-controlled, multicenter Phase II trial in Taiwan, aiming to enroll a total of 94 female participants. Participants will be randomly assigned (1:1 ratio) to receive either a single 1.0 mg dose of the pBI-4 vaccine or a placebo. The study drug or placebo will be administered intramuscularly in the thigh muscle using the TriGrid™ Delivery System version 2.0 (TDS-IM v2.0), a specialized device that applies short, mild electrical pulses (electroporation) to help cells take up the vaccine and stimulate a stronger immune response.
The primary goal of the study is to compare the rate of HPV16 viral clearance between the vaccine and placebo groups at Month 6. The study also features an adaptive design: an interim analysis will be conducted after approximately 50% of participants complete their 6-month assessment. If the initial single-dose regimen shows suboptimal efficacy at the interim stage, the trial may adaptively switch to a two-dose (prime-boost) regimen administered one month apart for the remaining participants. All participants will be closely monitored for safety, side effects, and immune responses for a total duration of 12 months.
STUDY OVERVIEW AND TRIAL DESIGN This study is a randomized, double-blind, placebo-controlled, multicenter Phase II clinical trial in Taiwan to evaluate the safety, efficacy, tolerability, and immunogenicity of the pBI-4 therapeutic DNA vaccine administered via the clinical-stage Intramuscular TriGrid™ Delivery System version 2.0 (TDS-IM v2.0) [1-4]. The target study population consists of adult female subjects aged 19 years and older who have biopsy-confirmed Grade 1 cervical intraepithelial neoplasia (CIN1) with concurrent Human Papillomavirus type 16 (HPV16) infection, or who exhibit persistent (defined as 6 months or longer) HPV16 infection with normal cytology (CIN\<1) [5-8].
A maximum target of 94 eligible subjects will be enrolled and randomized in a 1:1 ratio into two parallel groups: 47 subjects in the active pBI-4 vaccine group and 47 subjects in the placebo group [1, 4, 9].
THERAPEUTIC VACCINE AND ELECTROPORATION DELIVERY MECHANISM The investigational drug, pBI-4, is a clinical-grade, 6,999 base-pair circular plasmid DNA vaccine [10-12]. It is engineered to express human calreticulin (CRT) linked to codon-optimized HPV16 E6, E7, and L2 residues (amino acids 11-200) [11]. To ensure clinical safety, the gene sequences encoding the HPV16 E6 and E7 proteins incorporate specific mutations that disable their native oncogenic functions [10, 11, 13].
The vaccine (at a dose of 1.0 mg in 1.0 mL volume) or placebo (1.0 mL of phosphate-buffered saline) is administered intramuscularly into the vastus lateralis (thigh) muscle [1, 14, 15]. To overcome the historical limitation of low cellular DNA uptake in humans, the trial utilizes the automated TDS-IM v2.0 delivery system [14, 16-18]. During the automated administration sequence (which takes approximately 10 seconds), the device deploys an injection needle and four surrounding electrodes into the muscle [19]. Following fluid delivery, short, mild electrical pulses are applied to the local tissue [19]. This electroporation process transiently opens pores in cell membranes, enhancing intracellular plasmid DNA uptake and antigen expression by 2 to 3 orders of magnitude compared to standard needle injections [16, 19, 20].
TWO-STAGE ADAPTIVE REGIMEN MODIFICATION The trial employs a two-stage group-sequential design featuring a pre-specified, non-binding adaptive regimen modification [3, 21]. A single interim analysis will be conducted by an independent Data Safety Monitoring Board (DSMB) once approximately 50% of the randomized participants (approximately 42 patients) complete their Month 6 primary assessment [9, 22].
At the interim analysis, the DSMB will calculate the conditional power (CP) based on the primary efficacy endpoint (HPV16 clearance rate) under the design alternative (assuming a 60% clearance rate in the vaccine group versus a 30% clearance rate in the placebo group) [9, 21, 23].
CLINICAL EVALUATIONS AND FOLLOW-UP TIMELINE
All participating subjects will undergo structured clinical assessments across multiple visits:
If the adaptive two-dose regimen is triggered, Stage 2 participants will undergo an additional vaccination visit at Month 2 Day 1 (with pre-dose safety labs and a pregnancy test) and a subsequent post-vaccination telephone call at Week 9 to document tolerability and safety parameters [24, 40].
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with CIN1 on and whose cytologic sample is HPV16+ by Roche Cobas test in the past 30 days, OR patients with CIN\<1 on biopsy whose cytologic sample is HPV16+ by Roche Cobas test in the past 30 days and a history of a second HPV16+ test at least 6 months prior
White blood cell count > 3,000/mcL Absolute lymphocyte number > 500/mcL > 1,000/mcL > 90,000/mcL > 9 g/dL Total \< 3 x institutional limit of normal (SGOT)/ALT(SGPT) \< 3 x institutional limit of normal Creatinine \< 2.5 x institutional limit of normal Women of must agree to use effective (hormonal and/or barrier) prior to study entry and for the duration of the study
Exclusion Criteria:
Patients with AIS (adenocarcinoma in situ) or cancer determined by cervical cytology at study entry
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A clinical-grade, 6,999 base-pair circular recombinant plasmid DNA vaccine (pBI-4) engineered to express human calreticulin (CRT) linked to codon-optimized HPV16 E6, E7, and L2 residues (amino acids 11-200). To ensure clinical safety, E6 and E7 incorporate inactivating mutations to disable their native oncogenic transforming activities. Administered at a dose of 1.0 mg (1.0 mL) intramuscularly into the thigh muscle using the TDS-IM v2.0 electroporation device.
Biological: pBI-4 Vaccine
Placebo
Biological: pBI-4 Vaccine
A clinical-grade, 6,999 base-pair circular recombinant plasmid DNA vaccine (pBI-4) engineered to express human calreticulin (CRT) linked to codon-optimized HPV16 E6, E7, and L2 residues (amino acids 11-200). To ensure clinical safety, E6 and E7 incorporate inactivating mutations to disable their native oncogenic transforming activities. Administered at a dose of 1.0 mg (1.0 mL) intramuscularly into the thigh muscle using the TDS-IM v2.0 electroporation device.
Proportion of subjects exhibiting virological clearance of HPV16 and histopathological regression of cervical lesions to < CIN2 at Month 6
The proportion of subjects with histopathologically confirmed HPV16-associated CIN2 or CIN3 who exhibit virological clearance of HPV16 and regression of cervical lesions to \< CIN2 at Month 6.
Time frame: Month 6 (or 6 months post-vaccination)
Plan to share: No — No individual participant data will be shared with persons other than the investigators of this study to protect participant confidentiality.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Mar 2030, 42 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital →