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

ConditionsHPV InfectionHPV-Related Cervical Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorBlueSky Immunotherapies GmbH

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • FluBHPVE6E7

    Biological/Vaccine

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

  • Placebo

    Drug

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: FluBHPVE6E7Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
7 days

Secondary outcomes

1

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

To evaluate the induction of HPV16 E6- and E7-specific T-cells (%) by IFN-gamma ELISPOT analysis.

Time frame
16 weeks
2

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

To evaluate the induction of systemic vector-specific antibodies by HAI assay.

Time frame
16 weeks
3

Local HPV clearance

To evaluate the status of HPV-16 infection by HPV test (yes or no).

Time frame
16 weeks
4

Cervical cytology

To evaluate changes in cervical cytology by Pap smear. Results are reported as Pap results according to the Bethesda System.

Time frame
16 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BlueSky Immunotherapies GmbH

Lead sponsor

Source ClinicalTrials.gov
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