HPV Infection Clinical Trial
Official title:
Randomised, Double-blind, Placebo-controlled Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women With NILM, ASC-US, LSIL or Low-grade CIN
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).
Status | Recruiting |
Enrollment | 20 |
Est. completion date | November 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 49 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Slovakia | Univerzitná nemocnica Bratislava | Bratislava |
Lead Sponsor | Collaborator |
---|---|
BlueSky Immunotherapies GmbH |
Slovakia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency and severity of adverse events (AEs) | The severity of the adverse event is assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. | 7 days | |
Secondary | Induction of HPV-specific T-cell response following FluBHPVE6E7 administration | To evaluate the induction of HPV16 E6- and E7-specific T-cells (%) by IFN-gamma ELISPOT analysis. | 16 weeks | |
Secondary | Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) following FluBHPVE6E7 administration | To evaluate the induction of systemic vector-specific antibodies by HAI assay. | 16 weeks | |
Secondary | Local HPV clearance | To evaluate the status of HPV-16 infection by HPV test (yes or no). | 16 weeks | |
Secondary | Cervical cytology | To evaluate changes in cervical cytology by Pap smear. Results are reported as Pap results according to the Bethesda System. | 16 weeks | |
Secondary | Biodistribution: Detection of FluBHPVE6E7 in blood samples | To evaluate the presence of FluBHPVE6E7 by quantification of FluBHPVE6E7 genome copies in blood samples by RT-qPCR (copies per ml blood). | 16 weeks | |
Secondary | Biodistribution: Detection of FluBHPVE6E7 in saliva | To evaluate the presence of FluBHPVE6E7 by qualitative real-time PCR assay specific for influenza B virus (positive or negative). | 16 weeks | |
Secondary | Viral shedding: Detection of FluBHPVE6E7 in vaginal secretion samples | To evaluate the presence of FluBHPVE6E7 by quantification of FluBHPVE6E7 genome copies in vaginal secretion samples by RT-qPCR (copies per sample). | 16 weeks | |
Secondary | Number of participants with adverse events (type, frequency, severity). | To assess the safety and tolerability of FluBHPVE6E7 by monitoring the type, frequency, and severity of AEs. | 16 weeks |
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