Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women (NCT05829629) | Clinical Trial Compass
RecruitingPhase 1
Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women
Slovakia20 participantsStarted 2023-09-12
Plain-language summary
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).
Who can participate
Age range18 Years – 49 Years
SexFEMALE
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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-li…