Study of FluBHPVE6E7 in HPV-16 Infected Women (NCT04490512) | Clinical Trial Compass
CompletedPhase 1
Study of FluBHPVE6E7 in HPV-16 Infected Women
Austria28 participantsStarted 2020-12-09
Plain-language 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.
Who can participate
Age range18 Years – 49 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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
Exclusion criteria:
* Seropositivity (i.e. HAI titres \>1:20) to the vector-derived wild type virus
* Any vaccin…
What they're measuring
1
Number of participants with adverse events (type, frequency, severity).