Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05829629
Status:
RECRUITING
Last Update Posted:
2023-09-14
First Post:
2023-04-11
Brief Title:
Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women
Sponsor:
BlueSky Immunotherapies GmbH
Organization:
BlueSky Immunotherapies GmbH
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None