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

NCT05829629 | Recruiting Phase 1 DMC

• 1 other identifier: BS-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

HPV Infection; HPV-Related Cervical Carcinoma

Outcome Measures

Primary Outcomes (1)

• Frequency and severity of adverse events (AEs)

  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.

  7 days

Secondary Outcomes (8)

• Induction of HPV-specific T-cell response following FluBHPVE6E7 administration

  16 weeks

• Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) following FluBHPVE6E7 administration

  16 weeks

• Local HPV clearance

  16 weeks

• Cervical cytology

  16 weeks

• Biodistribution: Detection of FluBHPVE6E7 in blood samples

  16 weeks

Study Arms (2)

FluBHPVE6E7

EXPERIMENTAL

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

Biological: FluBHPVE6E7

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

FluBHPVE6E7 BIOLOGICAL

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

FluBHPVE6E7

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Participants are assigned females at birth.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• BlueSky Immunotherapies GmbH: lead

Study Sites (1)

Univerzitná nemocnica Bratislava

Bratislava, 82606, Slovakia

RECRUITING

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

BlueSky Clinical Operations

CONTACT

+43 664 1888028; clinical@bluesky-itx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 26, 2023
• Study Start: September 12, 2023
• Primary Completion: September 1, 2025
• Study Completion: November 1, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

SL (1)