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New treatment option for HPV Infection
Official title Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women
ClinicalTrials.gov ID: NCT05829629
What this study is testing
What is FluBHPVE6E7?
FluBHPVE6E7 is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for hpv infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- BS-02 is a randomised, double-blind, placebo-controlled, phase 1 dose escalation study to assess the safety, tolerability and immunogenicity of FluBHPVE6E7, in women infected with HPV-16. with 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).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 49, women only
You may be able to join if
- Females, 18-49 years of age with HPV16 infection and cervical cytological evaluation negative for intraepithelial lesion or malignancy (NILM)...
- 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
You likely can't join if
- 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...
See the full eligibility 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...
- 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bratislava, Slovakia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 49 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bratislava, Slovakia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.