NWRD09 vaccine in persistent anal HPV16 infection
Official title: An Exploratory Clinical Study of NWRD09 in Participants With Persistent HPV16 Infection in the Anal Region: Safety and Preliminary Efficacy Observation
Run by Newish Biotech (Wuxi) Co., Ltd. · NCT07710664 · Data updated 2026-11-12
A small, open-label study tests whether the NWRD09 therapeutic vaccine can help people with persistent HPV16 infection in the anal area.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Newish Biotech (Wuxi) Co., Ltd. Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | July 20, 2026 |
| Main results expected | December 30, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | July 17, 2026 |
| Trial ID | NCT07710664 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–60 with documented persistent anal HPV16 infection for at least 12 months and low-grade histology or no abnormality.
✕Probably not a fit
Patients with high-grade lesions, invasive cancer, or contraindications to vaccination may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, investigator-initiated phase 1/early exploratory trial enrolling 10 adults with persistent anal HPV16 infection. Participants are assigned to two parallel treatment groups, with a sentinel participant in each group and a 7-day post-dose safety observation before additional enrollment. The study will assess safety and tolerability, along with immunogenic responses and preliminary signs of efficacy such as HPV16 DNA clearance, cytological improvement, and histopathological changes (where applicable) up to Week 28. No control arm is described, and outcomes focus on safety, immune response, and early indicators of lesion-grade change and viral clearance.
Why it matters
Potential benefit: If successful, participants may experience HPV16 DNA reduction and improvements in lesion status, potentially informing future therapies.
How similar studies have gone: Therapeutic HPV vaccines have shown immunogenicity in several exploratory studies, but efficacy signals in persistent anal HPV16 infection remain emerging.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Female and male, aged 18 to 60 years (inclusive). 2. HPV DNA genotyping of anal specimens demonstrates positivity for HPV16, with documented persistence for at least 12 months (≥12 months). 3. Histopathological findings show low-grade lesion, inflammation, or no abnormality. 4. Adequate organ function within 4 week before the first dose. 5. For premenopausal women of childbearing potential: a negative serum pregnancy test within 4 weeks 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. 6. 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. Key Exclusion Criteria: 1. Any histopathologically confirmed adenocarcinoma/adenocarcinoma in situ (AIS), high-grade cervical, vulvar, vaginal, or anal intraepithelial neoplasia, or invasive cancer. 2. Pregnant or breastfeeding women, or those planning to become pregnant during the study period. 3. Participation in another clinical trial within 30 days prior to screening, or currently being in the follow-up period of another clinical trial. 4. Continuous use (for \>1 week) of systemic corticosteroids at a dose equivalent to \>10 mg/day of prednisone within 30 days prior to screening, with the exception of hormone replacement therapy and topical administration (e.g., intratracheal, ophthalmic). 5. Continuous use (for \>1 week) of immunosuppressants (e.g., cyclosporine, tacrolimus, azathioprine, 6-mercaptopurine, antilymphocyte globulin) within 30 days prior to screening. 6. Receipt of any inactivated or live vaccine within 4 weeks prior to the first dose of study drug. 7. Receipt of any AIN-related drug or physical therapy within 4 weeks prior to the first dose. 8. History of any therapeutic HPV vaccination (prior receipt of licensed prophylactic HPV vaccines is acceptable). 9. Use of blood or blood-related products (including immunoglobulins) within 3 months prior to the first dose, or planned use during the study period. 10. History of immunodeficiency or autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, etc.).
Where it's running
-
Peking University First Hospital
Beijing, China Recruiting
Study contacts
- Principal investigator: Pengyuan Wang, MD — Peking University First Hospital
- Study coordinator: Dr. Chen Zeyang, MD
- Email: chenzeyang_pku@163.com
- Phone: +86-13051555186
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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NWRD09 for Persistent HPV16 Infection in Women
This study tests whether NWRD09 given as injections can help adult women with long-lasting HPV16 cervical infection compared with a placebo.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.