Persistent Cervical HPV16 InfectionNCT07710703
NWRD09 for Persistent Cervical HPV16 Infection
A study of Persistent Cervical HPV16 Infection, run by Newish Biotech (Wuxi) Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo controlled study to determine the efficacy and safety of NWRD09 in adult women with persistent cervical HPV16 infection. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Persistent Cervical HPV16 Infection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2026to 31 May 2027
- Phase
- Interventional
- 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, aged 45 to 65 years (inclusive).
- Documented positive result for HPV 16 from a cervical sample collected at screening, with a confirmed duration of positivity for at least 12 months before screening.
- Satisfactory colposcopy examination. For participants with concomitant cervical LSIL, the entire aceto-white staining area or the suspected cervical intraepithelial neoplasia (CIN) lesion, including the upper border of the transformation zone, must be fully visualized.
- Adequate organ function within 1 week before the first dose, defined as:
- 1) Hematology: Hemoglobin (Hb) ≥ 100 g/L; Platelet count (PLT) ≥ 75 × 10⁹/L; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L.
- 2) Hepatic: Total bilirubin (TB) ≤ 1.5 × Upper Limit of Normal (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 1.5 × ULN; Plasma albumin ≥ 30 g/L.
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- 3) Renal: Serum creatinine (Scr) ≤ 1.5 × ULN, or calculated creatinine clearance ≥ 60 mL/min (using the Cockcroft-Gault formula) [for participants with serum creatinine > 1.5 × ULN].
- For premenopausal women of childbearing potential: a negative serum pregnancy test within 7 days before the first dose. Eligible participants of childbearing potential and their partners must agree to use highly effective contraception throughout the trial and for 6 months after the last study dose (at Week 12).
- Ability to understand the study and voluntarily provide written informed consent (ICF), willingness and ability to communicate effectively with the investigator, and to comply with all protocol-required treatment, examinations, and visits.
Who cannot join
- Any histopathologically confirmed cervical adenocarcinoma/adenocarcinoma in situ (AIS), high-grade cervical, vulvar, vaginal, or anal intraepithelial neoplasia, or invasive cancer.
- Cervical cytology results indicating ASC-H (Atypical Squamous Cells - cannot exclude HSIL), HSIL (High-grade Squamous Intraepithelial Lesion), SCC (Squamous Cell Carcinoma), AGC (Atypical Glandular Cells), or AIS; *Exception: Participants with ASC-H or HSIL may be enrolled if histopathological evidence confirms no lesion or CIN1, upon investigator's assessment.*.
- Pregnant or lactating women, or individuals planning to conceive during the study period.
- Participation in another clinical trial within 30 days before screening, or currently within the observational follow-up period of another clinical trial.
- Continuous systemic corticosteroid therapy (at a dose equivalent to >10 mg/day of prednisone) for more than one week within 30 days before screening; Exceptions: Hormone replacement therapy, and local administration (e.g., intra-tracheal, ocular).
- Continuous use of immunosuppressants (e.g., cyclosporine, tacrolimus, azathioprine, 6-mercaptopurine, antilymphocyte globulin) for more than one week within 30 days before screening.
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- Administration of any non-live vaccine within 4 weeks, or any live vaccine within 4 weeks, before the first dose.
- History of receiving any therapeutic HPV vaccination; Note: Vaccination with approved prophylactic HPV vaccines is acceptable.
- Use of blood or blood-derived products (including immunoglobulins) within 3 months before the first dose, or planned use during the study period.
- History of immunodeficiency or autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis).
- Current or anticipated use during the study period of disease-modifying antirheumatic drugs (e.g., azathioprine, cyclophosphamide, cyclosporine, methotrexate) or biologic disease-modifying agents (e.g., infliximab, adalimumab, etanercept).
- History of solid organ or bone marrow transplantation.
- History or current diagnosis of other malignancies.
- Presence of active infection requiring systemic therapy (including active tuberculosis, active syphilis, and bacterial, fungal, or viral infections requiring systemic treatment).
- Positive test results for any of the following: Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (anti-HCV), Treponema pallidum antibody (TP-Ab), or Human Immunodeficiency Virus antibody (anti-HIV).
- Known history of allergy to any component of the investigational product or similar drugs; or history of severe allergy to any food, drug, or other substances (e.g., urticaria, eczema, dyspnea, angioedema).
- Severe dysfunction of other organs or severe cardiopulmonary disease.
- Presence of tattoos, scars, or active lesions/rashes within a 2 cm radius of the intended injection site (deltoid muscle) that may interfere with safety assessment.
- Known psychiatric disorders or substance abuse disorders that may interfere with the subject's ability to comply with study requirements.
- Any condition, therapy, laboratory abnormality, history of other circumstances, or current evidence that, in the investigator's judgment, may increase the risk associated with study participation or investigational product administration, may interfere with the interpretation of study results, or render the participant unsuitable for enrollment in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of NWRD09 in Patients With Persistent Cervical HPV16 Infection
This is a randomized, double-blind, placebo controlled study to determine the efficacy and safety of NWRD09 in adult women with persistent cervical HPV16 infection.
Read the detailed description
This is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of NWRD09 in patients with persistent cervical HPV16 infection who may or may not have concomitant cervical LSIL. Eligible participants will be randomized in a 1:1 ratio to two groups: NWRD09 and placebo.
Participants will receive intramuscular injections of either NWRD09 or placebo at the corresponding dose at weeks 0, 2, 4, and 12 (a total of 4 doses).
Efficacy evaluations at Week 16 will include cervical cytology and HPV testing.
- Conditions
- Persistent Cervical HPV16 Infection
- Being tested
- NWRD09/ Placebo administered by IM injection
- Keywords
- NWRD09, HPV16, Persistent Infection
- Medical subject headings
- Persistent Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NWRD09/ Placebo administered by IM injectionBiological
NWRD09/ Placebo
| Study group | Role | What they receive |
|---|---|---|
| NWRD09 | Experimental | Each participant will be administered NWRD09 by IM injection at weeks 0, 2, 4, and 12. Receives: Biological: NWRD09/ Placebo administered by IM injection |
| Placebo | Placebo comparator | Each participant will be administered placebo by IM injection at weeks 0, 2, 4, and 12. Receives: Biological: NWRD09/ Placebo administered by IM injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with virologically-proven clearance of HPV 16 at week 16.
The number of participants with virologically-proven clearance of HPV 16 at week 16.
Measured: Week 16
Secondary outcomes (5)
Incidence and severity of local and systemic adverse events (AEs).
Based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V5.0, adverse events (AEs) and serious adverse events (SAEs) will be monitored.
Measured: up to 36 weeks
Proportion of participants with virologically-proven clearance of HPV 16 at week 28.
The number of participants with virologically-proven clearance of HPV 16 at week 28.
Measured: Week 28
Proportion of participants with virologically-proven clearance of HPV 16 at weeks 16 and 28.
The number of participants with virologically-proven clearance of HPV 16 at weeks 16 and 28.
Measured: Weeks 16、28
Proportion of participants with baseline cervical LSIL showing histopathological regression to no lesions at 28 weeks after the first dose.
The number of participants with cervical LSIL showing histopathological regression to no lesions at week 28.
Measured: Week 28
Levels of cellular immune responses.
Levels of cellular immune responses measured by interferon-gamma enzyme-linked immunospot (IFN-γ ELISPOT) assay in peripheral blood mononuclear cells (PBMCs) of participants at baseline and at weeks 6, 16, 28.
Measured: Weeks 6, 16 , 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start10 Feb 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Cervical HPV16 InfectionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newish Biotech (Wuxi) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710703
- Sponsor's protocol ID
- NWRD09-201
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- 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 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of NWRD09 in Patients With Persistent Cervical HPV16 Infection
- ClinicalTrials.gov ID
- NCT07710703
- Acronym / sponsor ID
- NWRD09-201
- Conditions
- Persistent Cervical HPV16 Infection
- Keywords
- NWRD09, HPV16, Persistent Infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Newish Biotech (Wuxi) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 17 Jul 2026 (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 a randomized, double-blind, placebo controlled study to determine the efficacy and safety of NWRD09 in adult women with persistent cervical HPV16 infection.
Detailed description
This is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of NWRD09 in patients with persistent cervical HPV16 infection who may or may not have concomitant cervical LSIL. Eligible participants will be randomized in a 1:1 ratio to two groups: NWRD09 and placebo.
Participants will receive intramuscular injections of either NWRD09 or placebo at the corresponding dose at weeks 0, 2, 4, and 12 (a total of 4 doses).
Efficacy evaluations at Week 16 will include cervical cytology and HPV testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NWRD09 | Experimental | Biological: NWRD09/ Placebo administered by IM injectionEach participant will be administered NWRD09 by IM injection at weeks 0, 2, 4, and 12. |
| Placebo | Placebo comparator | Biological: NWRD09/ Placebo administered by IM injectionEach participant will be administered placebo by IM injection at weeks 0, 2, 4, and 12. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female, aged 45 to 65 years (inclusive).
- Documented positive result for HPV 16 from a cervical sample collected at screening, with a confirmed duration of positivity for at least 12 months before screening.
- Satisfactory colposcopy examination. For participants with concomitant cervical LSIL, the entire aceto-white staining area or the suspected cervical intraepithelial neoplasia (CIN) lesion, including the upper border of the transformation zone, must be fully visualized.
- Adequate organ function within 1 week before the first dose, defined as:
- 1) Hematology: Hemoglobin (Hb) ≥ 100 g/L; Platelet count (PLT) ≥ 75 × 10⁹/L; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L.
Key exclusion criteria (20 listed)
- Any histopathologically confirmed cervical adenocarcinoma/adenocarcinoma in situ (AIS), high-grade cervical, vulvar, vaginal, or anal intraepithelial neoplasia, or invasive cancer.
- Cervical cytology results indicating ASC-H (Atypical Squamous Cells - cannot exclude HSIL), HSIL (High-grade Squamous Intraepithelial Lesion), SCC (Squamous Cell Carcinoma), AGC (Atypical Glandular Cells), or AIS; *Exception: Participants with ASC-H or HSIL may be enrolled if histopathological evidence confirms no lesion or CIN1, upon investigator's assessment.*.
- Pregnant or lactating women, or individuals planning to conceive during the study period.
- Participation in another clinical trial within 30 days before screening, or currently within the observational follow-up period of another clinical trial.
- Continuous systemic corticosteroid therapy (at a dose equivalent to >10 mg/day of prednisone) for more than one week within 30 days before screening; Exceptions: Hormone replacement therapy, and local administration (e.g., intra-tracheal, ocular).
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 |
|---|---|---|
| NWRD09/ Placebo administered by IM injectionNWRD09/ Placebo | Biological | NWRD09, Placebo |
Primary outcome
Proportion of participants with virologically-proven clearance of HPV 16 at week 16.
Time frame: Week 16
The number of participants with virologically-proven clearance of HPV 16 at week 16.
5 secondary outcomes
Incidence and severity of local and systemic adverse events (AEs).
Time frame: up to 36 weeks
Proportion of participants with virologically-proven clearance of HPV 16 at week 28.
Time frame: Week 28
Proportion of participants with virologically-proven clearance of HPV 16 at weeks 16 and 28.
Time frame: Weeks 16、28
Proportion of participants with baseline cervical LSIL showing histopathological regression to no lesions at 28 weeks after the first dose.
Time frame: Week 28
Levels of cellular immune responses.
Time frame: Weeks 6, 16 , 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Persistent Cervical HPV16 Infection, run by Newish Biotech (Wuxi) 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 9 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: looking for participants now, as of the sponsor's last update on 17 Jul 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 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. Some participants in this study may receive a placebo. 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?
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?
Contact Jian Zhao, M.D. (+86-15601199333, 854496@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with virologically-proven clearance of HPV 16 at week 16. (time frame: Week 16). 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 17 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.