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
BlueSky Immunotherapies GmbH
20 participants
Sep 12, 2023
INTERVENTIONAL
Conditions
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).
Eligibility
Plain Language Summary
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Interventions
Intracervical administration for first dose followed by intramuscular administration for subsequent doses at recommended dose level and determined schedule
Intracervical administration for first dose followed by intramuscular administration for subsequent doses at determined schedule
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05829629