Testing a new treatment for HPV16-infected women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 dose-escalation study evaluates the safety, tolerability, and immunogenicity of FluBHPVE6E7, an immunotherapeutic agent designed to target HPV infections and related cervical conditions. The study involves administering FluBHPVE6E7 three times at two different dose levels, with the first dose given directly into the cervix and subsequent doses administered intramuscularly. Participants will be women aged 18-49 who are infected with HPV16 and have specific cervical cytological evaluations indicating low-grade abnormalities or no malignancy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Females, 18-49 years of age with HPV16 infection and cervical cytological evaluation negative for intraepithelial lesion or malignancy (NILM), atypical squamous cells of undetermined significance (ASC-US), low grade squamous intraepithelial lesion (LSIL), or low-grade cervical intraepithelial neoplasia (CIN1)
* HPV16 infection has been confirmed at least twice by a validated HPV test separated by at least 3 months
* Satisfactory colposcopy
* No clinically significant out of range haematological, renal or hepatic laboratory tests
* Normal screening ECG or screening ECG with no clinically significant findings, as judged by the investigator
* Negative serum pregnancy test at screening
* Agree to use a reliable form of contraception during the whole study period.
* Provides written informed consent

Exclusion Criteria:

* Any vaccination within 6 weeks of day 0
* Active significant viral infections including influenza, CMV, and EBV within 30 days of receiving study treatment
* Co-infection with hepatitis B, hepatitis C, or HIV or having other immune deficient states
* Current Bacterial Vaginosis (BV) infection
* Current high-grade cervical intraepithelial neoplasia (CIN2/3)
* Prior history of or current malignancy, vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VAIN), atypical glandular cells (AGC), adenocarcinoma in situ (AIS) or any suspicion of either micro-invasive or invasive disease
* Pregnancy, breastfeeding
* Influenza-like illness (ILI) within 3 months of day 0
* Known hypersensitivity to oseltamivir or any of its components
* Any anatomical condition of the cervix, including that resulting from previous cervical surgery, congenital malformation or other condition, that would interfere with a complete evaluation of the cervix
* Current pelvic inflammatory disease, cervicitis, or other gynaecological infection as per colposcopy and clinical examination
* Serious, concomitant disorder, including active systemic infection requiring treatment
* Presence of acute or chronic bleeding or clotting disorder, or use of blood thinners within 2 weeks of day 0
* A proven or suspected autoimmune disease
* Immunosuppression including any concurrent condition requiring the continued use of systemic or topical steroids, or the use of immunosuppressive agents, disease modifying doses of anti-rheumatic drugs, and biologic disease modifying drugs. Any immunosuppressive agents containing corticosteroids or monoclonal antibodies specific for the treatment of obstructive airway, ear or vestibular diseases are permissible.
* Acute or history of Herpes genitalis
* Prior major surgery within 4 weeks of day 0
* Administration of any blood product within 3 months of enrolment
* Any current significant cardiac, hepatic or renal disease or history of clinically significant, medically unstable disease
* Any current or history of neurological disease including history of seizures
* Participation in another experimental protocol/use of investigational drug during the prior two months

Where it's running

• Univerzitná nemocnica Bratislava
  Bratislava, Slovakia Recruiting

Study contacts

• Study coordinator: BlueSky Clinical Operations
• Email: clinical@bluesky-itx.com
• Phone: +43 664 1888028

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing two treatments for persistent low-grade cervical lesions caused by high-risk HPV

  This study is testing whether a new light therapy or a laser treatment is better at helping women with long-lasting low-grade cervical lesions caused by high-risk HPV.

  Recruiting First Affiliated Hospital of Wenzhou Medical University · Wenzhou, Zhejiang · NCT06052033

• Risk of cervical cancer after HPV detection in healthy women

  This study tests how likely it is for cervical cancer to develop after different HPV detection patterns in healthy women who undergo HPV-based screening.

  Recruiting Karolinska Institutet · Stockholm · NCT07850128

• Dysplasix™ intravaginal suppositories for women with high‑risk HPV and mild cervical cell changes

  This trial tests whether nightly Dysplasix™ vaginal suppositories can clear high‑risk HPV and help mild cervical cell changes (ASC‑US or LSIL) in adult women.

  Recruiting Phase 2 Amplexd Therapeutics, Inc. · Shatin, New Territories · NCT07572396

• At-home HPV self-collection kits for cervical cancer screening

  We are testing different ways to give at-home HPV self-collection kits to under-screened people aged 25–65 to see if more of them complete cervical cancer screening and follow-up.

  Recruiting Washington University School of Medicine · St Louis, Missouri · NCT07453459

• Comparing clinic-only versus clinic plus community outreach to offer HPV self-collection for cervical screening in women with HIV

  This project will test whether adding community health worker outreach to clinic services helps more women living with HIV complete HPV self-collection for cervical screening.

  Recruiting UNC Lineberger Comprehensive Cancer Center · Kampala · NCT07428330

• CHW4CervixHealth: HPV self-collection kits with community health workers

  This project will test whether giving self-collection HPV kits during community workshops led by community health workers helps increase screening among under-screened women aged 25–65 and will first compare kit results to clinical Pap smears.

  Recruiting Thomas Jefferson University · Philadelphia, Pennsylvania · NCT07336134

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.