HPV16 and/or HPV18 infection
Conditions
Interventions
Cohort 1
* 100 mcg ProCervix (solution) on day 1 and day 42 and Imiquimod on day 1,2, 42
and 43.
Cohort 2
* 600 mcg ProCervix (solution) on day 1 and day 42 and Imiquimod on day 1,2, 42
and 43.
Co
Sponsors
Genticel, Pasteur-BioTop
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Female between the ages of 18 and 45 years (inclusive), in general good health with HPV infection confirmed by 2 genotyping tests showing one or both type 16 and type 18. 2. Subject has two consecutive normal cervical cytological evaluations, separated by 6 weeks to 12 months prior to enrolment. 3. Subject has a normal gynaecologic examination. 4. Subject has employed highly effective contraception for the month prior to the first vaccination and will agree to employ highly effective contraception for at least 4 months after the last vaccination. 5. Subject has a CD4+ total count *500cells/mm3. 6. Subject is in general good health based on medical history and clinically acceptable results, in the judgment of the Investigator, on the following assessments: physical examination, vital signs, clinical chemistry, and haematology.
Exclusion criteria
Exclusion criteria: 1. Subject has a current acute or chronic disease, other than infection with HPV that would increase the expected risk of exposure to ProCervix or Imiquimod or would be expected to interfere with the planned evaluations of response to ProCervix, in the judgment of the Investigator. 2. Subject has prior exposure to HPV prophylactic vaccine. 3. Subject has a history of cancer of the cervix or of untreated high grade abnormal cervical cytological evaluation. 4. Subject has received any prophylactic or therapeutic vaccine within 4 weeks of first vaccination. 5. Subject has current systemic infection or any history of primary or secondary systemic immunosuppression. 6. Subject has a history of severe allergy (requiring hospital care) or history of asthma requiring drug management in the last year. 7. Subject has a history of malignancy. 8. Subject was dosed with another investigational drug within 30 days prior to the Screening Visit. 9. Subject has a known history of hypersensitivity to Imiquimod. 10. Subject has a history of severe reaction to any drug or prior vaccination. 11. Subject has a medical condition with clinical and/or biological consequences judged by the investigator incompatible with vaccination(s). 12. Subject is known to have current infection with any other sexually transmitted infection. 13. Subject has a symptomatic vaginal or genital infection. 14. Subject is pregnant or is nursing. 15. Subject has participated in the past in another clinical trial of vaccination related to infection with HPV. 16. Subject has donated blood or plasma within 60 days prior to the Screening Visit. 17. Subject has a prior exposure to ProCervix. 18. Women negative for one or both HPV genotyping tests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: - treatment-emergent adverse events (AEs) including serious adverse events (SAEs) - treatment-emergent changes in clinical laboratory tests, - vital signs - physical examinations - exams directed at the vaccination site - observations on the status of HPV 16 and HPV 18 infection - cytology in cervical scrapings from before and after exposure to ProCervix Immunogenicity: - tests of humoral immunity to HPV - test of cellular immunity to HPV - assessment of cellular immune response (changes in peripheral blood [PB] T-cell responses to the E7 antigen of HPV 16 and HPV 18) - evaluation of serologic response (changes in anti-HPV 16 E7 and anti-HPV 18 E7 antibody titres) | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunological assessments other than the antigen specific measures listed above will be evaluated in subjects using available material from preserved peripheral blood mononuclear cells, plasma and cervical samples, to characterize immunological responses to ProCervix. | — |
Countries
Netherlands
Outcome results
None listed