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

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).

Eligibility

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

Conditions3

Browse More Trials