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Also known as qHPV vaccine
Human Papillomavirus vaccine · 1 trial · 1 indication
For this trial, the primary endpoint is high-grade squamous intraepithelial lesions (HSIL) or atypical squamous cells suggestive of HSIL found on cervical cytology, or HSIL found on cervical biopsy specimens at either the week 26 or week 52 visit.
| Arm | Type | Description |
|---|---|---|
| Human Papillomavirus vaccine | EXPERIMENTAL | Participants receive the experimental quadrivalent Human Papillomavirus vaccine at entry, week 4 and week 26. |
| Saline placebo | PLACEBO_COMPARATOR | The participants receive saline placebo at entry, week 4 and week 26. |
| Name | Type | Description |
|---|---|---|
| Human Papillomavirus vaccine | BIOLOGICAL | The participants receive the qHPV vaccine at entry, week 4 and week 26 |
Inclusion Criteria: 1. HIV infection 2. Women aged ≥ 18 years. 3. Cervical HSIL on biopsy (i.e. CIN2 and/or CIN3) 4. For participants of reproductive potential, negative serum or urine pregnancy test 5. All study participants must agree not to participate in a conception process (e.g., active attem...
The Human Papillomavirus vaccine is being studied in cervical high grade squamous intraepithelial lesion, a precancerous condition of the cervix. In this setting it is given alongside loop electrosurgical excision procedure (LEEP) treatment, with the goal of improving responses to that procedure. It is a vaccine modality and remains investigational for this oncology indication.
Merck & Company, Inc., which trades under the ticker MRK, is the developer of the Human Papillomavirus vaccine described here. Merck is the sponsor of the clinical program evaluating the vaccine in cervical high grade squamous intraepithelial lesion.
The Human Papillomavirus vaccine is in Phase 2 development for cervical high grade squamous intraepithelial lesion. The program has one completed Phase 2 trial and no active trials. It is investigational and is not approved for this indication.
The Human Papillomavirus vaccine has been evaluated in one completed Phase 2 trial, NCT01928225. That randomized, double-blind, placebo-controlled study enrolled 180 female participants aged 18 years and older and tested the quadrivalent HPV vaccine to improve responses to LEEP treatment of cervical HSIL.
NCT01928225 was a randomized, double-blind, placebo-controlled Phase 2 trial of the quadrivalent HPV vaccine in cervical high grade squamous intraepithelial lesion. It enrolled 180 female participants aged 18 years and older, did not include healthy volunteers, and has been completed.