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Human Papillomavirus vaccine

Phase 2

Cervical High Grade Squamous Intraepithelial Lesion | Monoclonal antibody | Oncology |Merck & Company, Inc.|Last Updated: Jun 24, 2020

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment180

FDA Designations

No designations recorded

Clinical trial landscape

Human Papillomavirus vaccine · 1 trial · 1 indication

Phase 2 1
NCT01928225Randomized, Double Blind Trial of the Quadrivalent HPV Vaccine to Improve Responses to LEEP Treatment of Cervical HSILCervical High Grade Squamous Intraepithelial Lesion
COMPLETED180 Analytics
PHASE2COMPLETED
Randomized, Double Blind Trial of the Quadrivalent HPV Vaccine to Improve Responses to LEEP Treatment of Cervical HSIL
Cervical High Grade Squamous Intraepithelial LesionUnlock trial analytics

Study Endpoints

Primary Endpoints

Cervical HSIL
up to 52 weeks

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.

Secondary Endpoints

Cervical Cytology
Week 26
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Human Papillomavirus vaccineEXPERIMENTALParticipants receive the experimental quadrivalent Human Papillomavirus vaccine at entry, week 4 and week 26.
Saline placeboPLACEBO_COMPARATORThe participants receive saline placebo at entry, week 4 and week 26.

Interventions

NameTypeDescription
Human Papillomavirus vaccineBIOLOGICALThe participants receive the qHPV vaccine at entry, week 4 and week 26
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo

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...

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Frequently asked questions about Human Papillomavirus vaccine

What is Human Papillomavirus vaccine used for in Cervical High Grade Squamous Intraepithelial Lesion?

Human Papillomavirus vaccine is being studied for use in Cervical High Grade Squamous Intraepithelial Lesion, a precancerous condition of the cervix. It is an investigational therapy in Phase 2 clinical development, evaluated as a treatment to improve responses to LEEP procedures in patients with this condition.

Who makes Human Papillomavirus vaccine?

Human Papillomavirus vaccine is developed by Merck & Company, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical research on this vaccine for the treatment of Cervical High Grade Squamous Intraepithelial Lesion.

What phase is Human Papillomavirus vaccine in?

Human Papillomavirus vaccine is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being evaluated in clinical trials for safety and efficacy in treating Cervical High Grade Squamous Intraepithelial Lesion.

What clinical trials is Human Papillomavirus vaccine in?

Human Papillomavirus vaccine is being studied in clinical trial NCT01928225, titled 'Randomized, Double Blind Trial of the Quadrivalent HPV Vaccine to Improve Responses to LEEP Treatment of Cervical HSIL.' This Phase 2 trial has been completed and enrolled 180 female participants aged 18 years and older.

What does Human Papillomavirus vaccine target?

Human Papillomavirus vaccine is a monoclonal antibody modality designed to target human papillomavirus. It is being evaluated for its ability to improve responses to LEEP treatment in patients with Cervical High Grade Squamous Intraepithelial Lesion, a condition associated with HPV infection.

Is Human Papillomavirus vaccine the same as the quadrivalent HPV vaccine?

Human Papillomavirus vaccine is referred to as the quadrivalent HPV vaccine in clinical trial NCT01928225. This investigational vaccine is being studied for its potential to improve responses to LEEP treatment in patients with Cervical High Grade Squamous Intraepithelial Lesion.