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

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BlueSky Immunotherapies GmbH

Criteria

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-like illness (ILI) within 3 months of day 0

• Known hypersensitivity to oseltamivir or any of its components

• Any anatomical condition of the cervix, including that resulting from previous cervical surgery, congenital malformation or other condition, that would interfere with a complete evaluation of the cervix

• Current pelvic inflammatory disease, cervicitis, or other gynaecological infection as per colposcopy and clinical examination

• Serious, concomitant disorder, including active systemic infection requiring treatment

• Presence of acute or chronic bleeding or clotting disorder, or use of blood thinners within 2 weeks of day 0

• A proven or suspected autoimmune disease

• Immunosuppression including any concurrent condition requiring the continued use of systemic or topical steroids, or the use of immunosuppressive agents, disease modifying doses of anti-rheumatic drugs, and biologic disease modifying drugs. Any immunosuppressive agents containing corticosteroids or monoclonal antibodies specific for the treatment of obstructive airway, ear or vestibular diseases are permissible.

• Acute or history of Herpes genitalis

• Prior major surgery within 4 weeks of day 0

• Administration of any blood product within 3 months of enrolment

• Any current significant cardiac, hepatic or renal disease or history of clinically significant, medically unstable disease

• Any current or history of neurological disease including history of seizures

• Participation in another experimental protocol/use of investigational drug during the prior two months