HSIL of CervixNCT05905354
Clinical Study of HPV Therapeutic DNA Vaccine (NWRD08) in Patients With Cervical HPV16 and/or HPV18 Positive
A study testing NWRD08 in people with HSIL of Cervix, run by Newish Technology (Beijing) Co., Ltd. at 1 site in China.
Trial summary
This is an open-label exploratory clinical study. The main objective is to explore the immunogenicity of HPV therapeutic DNA vaccine NWRD08. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HSIL of Cervix
- What is being tested?
- NWRD08
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 7 Mar 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years old;
- women who have sex;
- HPV16 and/or 18 DNA and E6E7 mRNA were positive;
- Patients with highly squamous intraepithelial lesions of the cervix confirmed by histology and cytology, or persistent cervical PV16 and/or 18 infection for more than 12 months;
- Cervical tissue specimens/sections should be provided 4 weeks before the first treatment of HISL;
- Electrocardiogram (ECG) is normal;
- Women of reproductive age must have a negative serum pregnancy test within 1 week prior to the first dose and have agreed to use effective contraception during the study drug use period and within 6 months after the last dose of the study drug. For males, it should be surgical sterilization or consent to effective contraception during the study drug use period and within 6 months after the last study drug administration;
- Have fully understood the study and voluntarily signed the ICF, be able to communicate well with the investigator and complete all treatments, examinations and visits required by the study protocol.
Who cannot join
- any histopathologically confirmed adenocarcinoma in situ (AIS), high-grade vulvar, vaginal or anal intraepithelial tumors, or invasive cancers;
- Patients with unsatisfactory colposcope;
- Patients who were satisfied with colposcopy but not satisfied with ECC (patients who were positive for HPV18 or had abnormal adenocytes on cervical cytology but satisfied with colposcopy should undergo ECC examination);
- Positive HPV type 31 or 33 or 45 or 52 or 58;
- Have received cervical physical therapy;
- pregnant, breastfeeding, or considering becoming pregnant during the study period;
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- previous history of therapeutic or preventive HPV vaccination;
- Received any non-investigational inactivated vaccine injection within 2 weeks;
- Received any non-investigational live vaccine within 4 weeks;
- Acute or chronic bleeding or coagulopathy;
- Less than two sites can be used for intramuscular injection;
- Received chemotherapy, molecular targeted therapy, biological immunotherapy, or Chinese patent drugs for cervical lesions within 30 days before or during screening;
- participated in other clinical trials within 30 days prior to screening, or was in the observation period of other clinical trials;
- Continuous (more than 1 week) glucocorticoid therapy (dose equivalent to prednisone \> 10 mg/ day), except hormone replacement therapy and endotracheal administration;
- History of immune deficiency or autoimmune disease (such as rheumatoid joint disease, systemic lupus erythematosus, multiple sclerosis, etc.);
- with uncontrolled severe infection;
- Patients with a history of hepatitis B virus (HBV), hepatitis C virus (HCV) infection or human immunodeficiency virus (HIV) infection or syphilis carriers;
- Patients with severe other organ dysfunction or cardiopulmonary disease, including myocardial infarction, stroke, congestive heart failure, severe lung disease, metabolic diseases, wound healing abnormalities, ulcers or fractures;
- Epilepsy accompanied by medication (such as steroids or antiepileptic drugs);
- Previous or present malignant neoplasms;
- A history of severe allergies, or a history of allergic diseases, or an allergic constitution, or a severe iodine contrast allergy, meeting any of these criteria;
- serious mental disorders;
- A history of drug or alcohol abuse;
- A pregnant or lactating woman, or a woman of childbearing age who has a positive blood pregnancy test, or a patient of childbearing age and her spouse who is unwilling to take effective contraceptive measures during the clinical study period and within 6 months after the end of treatment;
- Patients deemed unsuitable for this clinical trial by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Heze Municipal Hospital
Heze, Shandong
Sun Guodong, Master, (+86)0530-5613206, sunguodong0723@163.com
About this study
This is an open-label exploratory clinical study. The main objective is to explore the immunogenicity of HPV therapeutic DNA vaccine NWRD08.
Read the detailed description
The main objective is to explore the immunogenicity of HPV therapeutic DNA vaccine NWRD08.The secondary objective was to observe the safety of NWRD08 in cervical patients who were positive for HPV16 and/or HPV18, and to initially explore the efficacy of NWRD08.
- Conditions
- HSIL of Cervix
- Being tested
- NWRD08
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NWRD08Biological
Subjects in dose group 1 and 2 were intramuscularly injected with NWRD08 at week 0, week 4 and week 12 by electric pulse gene delivery instrument, respectively. Subjects in dose group 3 and 4 were intramuscularly injected NWRD08 at week 0, week 2, week 4 and week 12 by electric pulse gene delivery instrument, respectively.
| Study group | Role | What they receive |
|---|---|---|
| lose dose,high dose | Experimental | Four dose groups were set up: dose group 1, a single dose of 2mg, administered at week 0, 4 and 12, three times in total; Dose group 2, a single dose of 6mg, respectively at the 0, 4, 12 weeks, a total of 3 times; Dose group 3, a single dose of 2mg, was given at the 0, 2, 4, 12 weeks, a total of 4 times; Dose group 4, with a single dose of 6mg, was given 4 times at week 0, 2, 4 and 12, respectively. There were 3 subjects in each group. Climb from the low dose group to the high dose group. Receives: Biological: NWRD08 |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV 16/18 E6E7 specific immune response in peripheral blood after vaccination compared to before vaccination.
Analysis of immunogenicity data included the level, type, subtype, and time and duration of specific humoral and cellular immune responses in peripheral blood before and after vaccination.
Measured: Week36
Secondary outcomes (3)
Adverse Events (AEs)
Adverse Events (AEs), adverse events according to type, frequency, severity [according to the Classification Scale of Adverse Events in Clinical Trials for Preventive Vaccines issued by the Center for Drug Evaluation (CDE) of the National Medical Products Administration in 2019], occurrence time, and severity. And whether it's related to treatment.
Measured: End of study
proportion of patients with HPV virus clearance
Proportion of patients with negative HPV16/18 DNA and E6E7 mRNA.
Measured: Week 36
proportion of patients with regression of cervical lesions
- HSIL patients 36 weeks group / 18 DNA and E6E7 mRNA overcast and histological ratio dropped below CIN1 and patients;
- HSIL patients 36 weeks group / 18 DNA and E6E7 mRNA overcast and histological the proportion of patients with squamous intraepithelial lesions;
- LSIL patients 18 DNA and 36 weeks group/E6E7 mRNA overcast and cytology squamous intraepithelial lesions;
Measured: Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start7 Mar 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HSIL of CervixStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 3+3 dose climb
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newish Technology (Beijing) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sun Guodong, Master, Principal investigator, Shandong Heze Municipal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905354
- Sponsor's protocol ID
- NEWISH-HPV-001
- Status last verified
- May 2023
- First submitted
- 23 May 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of HPV Therapeutic DNA Vaccine (NWRD08) in Patients With Cervical HPV16 and/or HPV18 Positive
- ClinicalTrials.gov ID
- NCT05905354
- Acronym / sponsor ID
- NEWISH-HPV-001
- Conditions
- HSIL of Cervix
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Newish Technology (Beijing) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label exploratory clinical study. The main objective is to explore the immunogenicity of HPV therapeutic DNA vaccine NWRD08.
Detailed description
The main objective is to explore the immunogenicity of HPV therapeutic DNA vaccine NWRD08.The secondary objective was to observe the safety of NWRD08 in cervical patients who were positive for HPV16 and/or HPV18, and to initially explore the efficacy of NWRD08.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3+3 dose climb
| Arm | Type | Receives |
|---|---|---|
| lose dose,high dose | Experimental | Biological: NWRD08Four dose groups were set up: dose group 1, a single dose of 2mg, administered at week 0, 4 and 12, three times in total; Dose group 2, a single dose of 6mg, respectively at the 0, 4, 12 weeks, a total of 3 times; Dose group 3, a single dose of 2mg, was given at the 0, 2, 4, 12 weeks, a total of 4 times; Dose group 4, with a single dose of 6mg, was given 4 times at week 0, 2, 4 and 12, respectively. There were 3 subjects in each group. Climb from the low dose group to the high dose group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years old;
- women who have sex;
- HPV16 and/or 18 DNA and E6E7 mRNA were positive;
- Patients with highly squamous intraepithelial lesions of the cervix confirmed by histology and cytology, or persistent cervical PV16 and/or 18 infection for more than 12 months;
- Cervical tissue specimens/sections should be provided 4 weeks before the first treatment of HISL;
Key exclusion criteria (25 listed)
- any histopathologically confirmed adenocarcinoma in situ (AIS), high-grade vulvar, vaginal or anal intraepithelial tumors, or invasive cancers;
- Patients with unsatisfactory colposcope;
- Patients who were satisfied with colposcopy but not satisfied with ECC (patients who were positive for HPV18 or had abnormal adenocytes on cervical cytology but satisfied with colposcopy should undergo ECC examination);
- Positive HPV type 31 or 33 or 45 or 52 or 58;
- Have received cervical physical therapy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NWRD08Subjects in dose group 1 and 2 were intramuscularly injected with NWRD08 at week 0, week 4 and week 12 by electric pulse gene delivery instrument, respectively. Subjects in dose group 3 and 4 were intramuscularly injected NWRD08 at week 0, week 2, week 4 and week 12 by electric pulse gene delivery instrument, respectively. | Biological | lose dose,high dose |
Primary outcome
HPV 16/18 E6E7 specific immune response in peripheral blood after vaccination compared to before vaccination.
Time frame: Week36
Analysis of immunogenicity data included the level, type, subtype, and time and duration of specific humoral and cellular immune responses in peripheral blood before and after vaccination.
3 secondary outcomes
Adverse Events (AEs)
Time frame: End of study
proportion of patients with HPV virus clearance
Time frame: Week 36
proportion of patients with regression of cervical lesions
Time frame: Week 36
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for HSIL of Cervix
Active, not recruiting
Optimization of Cervical Cancer Screening Among Women Living With HIV in Latin American Countries
Cervix Cancer, HPV Infection
Not yet recruitingPhase 1/2
Evaluation of the Safety, Tolerability, Immunogenicity and Preliminary Efficacy of BBM-C101 Injection in Patients With Cervical High-Grade Squamous Intraepithelial Lesion(HSIL)
High-grade Squamous Intraepithelial Lesions of the Cervix Associated With Human Papillomavirus (HPV) Type 16 and/or HPV Type 18 Infection
Recruiting
Comparison Between Liquid-Based Cytology And Molecular Screening For Detecting Precursor Lesions and Cervical Cancer
I) Atypical Squamous Cells of Undetermined Significance (ASC-US), II) Atypical Glandular Cells of Uncertain Significance (AGUS)
Active, not recruitingObservational study
Primary Cervical Cancer Screening by Self-sampling HPV Test
Human Papillomavirus Infection, Cervical Cancer
RecruitingObservational study
Conservative Management of HSIL in Patients With Future Pregnancy Aspiration
Cervical Intraepithelial Neoplasia, Squamous Intraepithelial Lesions of the Cervix
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sun Guodong, Master principal investigator
Shandong Heze Municipal Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NWRD08 in people with HSIL of Cervix, run by Newish Technology (Beijing) Co., Ltd. at 1 site in China.
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 8 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 15 Jun 2023. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liu Defang, Doctor ((+86)010-87661655, ldf@newishes.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV 16/18 E6E7 specific immune response in peripheral blood after vaccination compared to before vaccination. (time frame: Week36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2023.