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JOURNAL ONKOLOGIE – STUDIE

Study of FluBHPVE6E7 in HPV-16 Infected Women

Rekrutierend

NCT-Nummer:
NCT04490512

Studienbeginn:
Dezember 2020

Letztes Update:
27.01.2021

Wirkstoff:
FluBHPVE6E7

Indikation (Clinical Trials):
Papillomavirus Infections

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
BlueSky Immunotherapies GmbH

Collaborator:
-

Kontakt

Studienlocations
(1 von 1)

Medical University of Vienna
1090 Vienna
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Michael Wolzt, MD
Phone: +43 (0)1 40400
Phone (ext.): 29810
E-Mail: klin-pharmakologie@meduniwien.ac.at
» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

BS-01 is a randomised, placebo-controlled, double- blind phase 1 dose-escalation study in

women with normal cytology or low-grade cervical intraepithelial neoplasia.

The primary objective is to assess the safety and tolerability of subcutaneous

administrations of FluBHPVE6E7. Secondary objectives are the assessment of the systemic

immune responses to immunisations with FluBHPVE6E7 , changes in HPV infection status and

cervical cytology, and biodistribution.

Study medication is administered subcutaneously three times (Day 0, Week 4, Week 12). Study

participants are randomised at a ratio of 3:1 for FluBHPVE6E7 or placebo. The first cohort is

treated at dose level 107.5 fTCID50/dose. The second cohort is treated at 109 fTCID50/dose.

Interim safety reviews are performed by a Data Monitoring Committee. After completion of the

dose-escalation and in order to collect additional safety data on the highest safe and

tolerated dose level, four additional study participants are enrolled into an expansion

cohort.

Ein-/Ausschlusskriterien

Inclusion criteria:

- 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 low-grade cervical intraepithelial neoplasia (CIN1), at screening

- 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

Exclusion criteria:

- 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

- 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.

- 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 (e.g. chronic renal failure; angina,

myocardial ischemia or infarction, congestive heart failure, cardiomyopathy, or

clinically significant arrhythmias)

- 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

- Any condition that, in the judgment of the investigator, might prevent safe

participation in the study or interfere with study objectives

- Unability to comply with the protocol requirements

Studien-Rationale

Primary outcome:

1. Number of participants with adverse events (type, frequency, severity). (Time Frame - 7 days):
To assess the safety and tolerability of FluBHPVE6E7 by monitoring the type, frequency, and severity of AEs



Secondary outcome:

1. Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) following FluBHPVE6E7 administration (Time Frame - 16 weeks):
To evaluate of the induction of systemic vector-specific antibodies by HAI assay

2. Induction of HPV-specific T-cell response following FluBHPVE6E7 administration (Time Frame - 16 weeks):
To evaluate the induction of HPV16 E6- and E7-specific T-cells (%) by IFN-gamma ELISPOT analysis

3. Induction of HPV-specific CD4+ and CD8+ T-cells following FluBHPVE6E7 administration (Time Frame - 16 weeks):
To evaluate the induction of HPV16 E6- and E7 specific T-cells (%) by ICS and FACS analysis

4. Local HPV clearance (Time Frame - 16 weeks):
To evaluate the status of HPV-16 infection by HPV test (yes or no)

5. Cervical cytology (Time Frame - 16 weeks):
To evaluate changes in cervical cytology by Pap smear. Results are reported as Pap results according to the Bethesda System

6. Biodistribution: Detection of FluBHPVE6E7 in blood samples (Time Frame - 16 weeks):
To evaluate the presence of FluBHPVE6E7 by quantification of FluBHPVE6E7 genome copies in blood samples by RT-qPCR (copies per ml blood)

7. Biodistribution: Detection of FluBHPVE6E7 in nasal secretions (Time Frame - 16 weeks):
To evaluate the presence of FluBHPVE6E7 by qualitative real-time PCR assay specific for influenza B virus (positive or negative)

8. Number of participants with adverse events (type, frequency, severity). (Time Frame - 16 weeks):
To assess the safety and tolerability of FluBHPVE6E7 by monitoring the type, frequency, and severity of AEs

Studien-Arme

  • Experimental: FluBHPVE6E7
    Multiple administration of FluBHPVE6E7
  • Placebo Comparator: Placebo
    Multiple administration of buffer solution

Geprüfte Regime

  • FluBHPVE6E7 (Placebo):
    Multiple subcutaneous administrations

Quelle: ClinicalTrials.gov


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