BS-FU01 Follow-Up Study of FluBHPVE6E7 Study Subjects

BlueSky Immunotherapies

Status: Completed

Conditions: HPV Infection; Safety Issues

Treatments: Other: Observation without intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT04528407

BS-FU01

Details and patient eligibility

About

This is a follow-up study for patients treated with FluBHPVE6E7 in previous interventional studies.

Full description

BS-FU01 is a follow-up study for patients treated with FluBHPVE6E7 in previous phase 1 and 2 interventional studies. The aim of the follow-up study is to assess the safety and immunogenicity of FluBHPVE6E7, changes in the HPV infection status, cervical cytology, and biodistribution after treatment with FluBHPVE6E7 in previous studies.

Enrollment: 25 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patient who enrolled in previous phase 1 or 2 clinical studies of FluBHPVE6E7
• Negative pregnancy test at baseline
• Written informed consent

Exclusion criteria

• Pregnancy, breastfeeding