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Disease Attributes

intracervical and intramuscular 0.5 ml per dose 3 doses (12 weeks)

Intracervical administration for first dose followed by intramuscular administration for subsequent doses at recommended dose level and determined schedule

FluBHPVE6E7

Intracervical administration for first dose followed by intramuscular administration for subsequent doses at determined schedule

Placebo

BlueSky Clinical Operations

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).

FluBHPVE6E7 is an influenza virus vector that was modified on several levels to be used as an immunotherapeutic agent against human papillomavirus (HPV) infections, and precancers and cancers induced by HPV.

Study BS-02 investigates the safety, tolerability and immunogenicity of FluBHPVE6E7 in HPV-16 infected women.

FluBHPVE6E7 is administered three times at two dose levels. The first dose is administered into the cervix, subsequent doses are administered intramuscularly.

Participants are assigned females at birth.

Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women

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

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.

To evaluate the induction of HPV16 E6- and E7-specific T-cells (%) by IFN-gamma ELISPOT analysis.

To evaluate the induction of systemic vector-specific antibodies by HAI assay.

To evaluate the status of HPV-16 infection by HPV test (yes or no).

To evaluate changes in cervical cytology by Pap smear. Results are reported as Pap results according to the Bethesda System.

To evaluate the presence of FluBHPVE6E7 by quantification of FluBHPVE6E7 genome copies in blood samples by RT-qPCR (copies per ml blood).

To evaluate the presence of FluBHPVE6E7 by qualitative real-time PCR assay specific for influenza B virus (positive or negative).

To evaluate the presence of FluBHPVE6E7 by quantification of FluBHPVE6E7 genome copies in vaginal secretion samples by RT-qPCR (copies per sample).

To assess the safety and tolerability of FluBHPVE6E7 by monitoring the type, frequency, and severity of AEs.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women	NCT05829629	HPV Infection HPV-Related Cer...	FluBHPVE6E7 Placebo	18 Years - 49 Years	BlueSky Immunotherapies GmbH
Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women	NCT05829629	HPV Infection HPV-Related Cer...	FluBHPVE6E7 Placebo	18 Years - 49 Years	BlueSky Immunotherapies GmbH

Spots Global Cancer Trial Database for flubhpve6e7

Every month we try and update this database with for flubhpve6e7 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for flubhpve6e7

Every month we try and update this database with for flubhpve6e7 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for flubhpve6e7 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.