Study of FluBHPVE6E7 in HPV-16 Infected Women

NCT04490512 | Completed Phase 1 DMC

• 1 other identifier: BS-01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

BS-01 is a randomised, double-blind, placebo-controlled, phase 1 dose escalation study assessing safety, tolerability and immunogenicity of FluBHPVE6E7, changes in the HPV infection status and cervical cytology, and biodistribution in HPV-16 infected women with normal cytology, CIN1 or CIN2. The safety and immunogenicity of two dose levels, 7.5 log10 and 9.0 log10 fTCID50/dose of FluBHPVE6E7 are assessed after three subcutaneous administrations. In addition the safety of 9.0 log10 fTCID50/dose of FluBHPVE6E7 is assessed after three intradermal or intramuscular administrations.

Conditions

HPV Infection

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events (type, frequency, severity).

  To assess the safety and tolerability of FluBHPVE6E7 by monitoring the type, frequency, and severity of AEs

  7 days

Secondary Outcomes (8)

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

  16 weeks

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

  16 weeks

• Induction of HPV-specific CD4+ and CD8+ T-cells following FluBHPVE6E7 administration

  16 weeks

• Local HPV clearance

  16 weeks

• Cervical cytology

  16 weeks

Study Arms (2)

FluBHPVE6E7

EXPERIMENTAL

Multiple administration of FluBHPVE6E7

Biological: FluBHPVE6E7

Placebo

PLACEBO COMPARATOR

Multiple administration of buffer solution

Biological: FluBHPVE6E7

Interventions

FluBHPVE6E7 BIOLOGICAL

Multiple subcutaneous, intradermal or intramuscular administrations

Also known as: Placebo

FluBHPVE6E7; Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females in general good health, EITHER 18-49 years of age with HPV-16 infection and cervical cytological evaluation with a normal result, OR 25-49 years of age, with HPV-16 infection, and histologically confirmed cervical intraepithelial neoplasia 1 (CIN1) or 2 (CIN2) for whom a "wait-and-see" approach for the study period is indicated
• HPV-16 infection has been confirmed at least twice by a validated HPV test separated by at least 3 months
• Satisfactory colposcopy (i.e. the entire cervix as well as the entire squamocolumnar junction can be visualized by colposcopy and there is no evidence of invasive cancer)
• 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. Reliable forms of contraception are hysterectomy or bilateral tubal ligation, hormonal methods (oral, injected, implanted or transdermal), intrauterine device, barrier method plus spermicide, history of a single male partner with vasectomy, or a history of abstinence deemed credible by the investigator. Furthermore, male partners should use condoms during the whole study period.
• Provides written informed consent

You may not qualify if:

• Seropositivity (i.e. HAI titres \>1:20) to the vector-derived wild type virus
• Any vaccination within 6 weeks of receiving study treatment
• Active significant viral infections including influenza, CMV, and EBV within 30 days of receiving study treatment
• Current cervical intraepithelial neoplasia 3 (CIN3)
• Co-infection with hepatitis B, hepatitis C, or HIV or having other immune deficient states
• Prior history of or current malignancy, high-grade cervical intraepithelial neoplasia (CIN2/3), 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) during the preceding 3 months
• 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 (e.g. anticoagulants or antiplatelet drugs) 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 (e.g., azathioprine, cyclophosphamide, cyclosporine, methotrexate), and biologic disease modifying drugs such as TNF-α inhibitors (e.g. infliximab, adalimumab or etanercept). Corticosteroids must be discontinued \> 4 weeks prior to day 0 of study medication administration. Eye drops or ear drops containing corticosteroids are permissible.

Sponsors & Collaborators

• BlueSky Immunotherapies GmbH: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

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

Study Design

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

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 29, 2020
• Study Start: December 9, 2020
• Primary Completion: March 16, 2023
• Study Completion: June 6, 2023
• Last Updated: June 26, 2023

Record last verified: 2023-06

Locations

AU (1)