Infections

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Neoplasms

Communicable Diseases

Condylomata Acuminata

Virus Diseases

Papillomavirus Infections

Papilloma

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

All Drugs and Chemicals

Vaccines

Immunologic Factors

Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36.

Participants received placebo 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36.

Formulated with aluminum hydroxyphosphate sulfate (AAHS) adjuvant

V501

Placebo

Medical Director

A study to evaluate the efficacy and tolerability of V501 (quadrivalent Human Papilloma Virus \[HPV\] \[Type 6, 11, 16 and 18\] L1 Virus-Like Particle vaccine, GARDASIL™) in healthy, 16- to 26-year old Japanese males. The hypotheses tested are: 1) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection compared with placebo, and 2) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection, condyloma acuminata, penile/perianal/perineal intraepithelial neoplasia, or penile, perianal, or perineal cancer compared with placebo.

Efficacy and Tolerability Study of V501 in Japanese Males (V501-122)

A Phase III Placebo-controlled Clinical Trial to Study the Tolerability, Immunogenicity and Efficacy of V501 in 16- to 26-year-old Japanese Men

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Persistent infection was defined as 1) polymerase chain reaction (PCR) positive to HPV Type 6, 11, 16, or 18 in 2 consecutive anogenital or biopsy samples collected ≥4 months apart, or 2) Pathology Panel consensus diagnosis of condyloma acuminate, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal, or perineal cancer and PCR detection of HPV Type 6, 11, 16, or 18 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit. The combined incidence of HPV Type 6, 11, 16, or 18 persistent infection detected in samples from ≥2 consecutive visits ≥6 months apart was assessed.

Body temperature (oral or oral equivalent) was recorded on the Vaccination Report Card (VRC). The percentage of participants with a maximum temperature ≥37.5°C was summarized.

An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, and swelling) was summarized.

An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The percentage of participants with a systemic AE was summarized.

An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. Vaccine-related AEs are those that were deemed possibly, probably, or definitely related to vaccine administration by the investigator. The percentage of participants with a vaccine-related systemic AE was summarized.

Persistent infection was defined as 1) polymerase chain reaction (PCR) positive to HPV Type 6, 11, 16, or 18 in 2 consecutive anogenital or biopsy samples collected ≥4 months apart, or 2) Pathology Panel consensus diagnosis of condyloma acuminate, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal, or perineal cancer and PCR detection of HPV Type 6, 11, 16, or 18 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit. The incidence of persistent infection detected in samples from ≥2 consecutive visits ≥6 months apart was assessed. Disease was defined as HPV Type 6, 11, 16, or 18-related condyloma acuminate, PIN, penile, perianal, or perineal cancer. The combined incidence of HPV Type 6, 11, 16, or 18 persistent infection or disease was assessed.

Merck Sharp & Dohme LLC

The at-risk population was participants who received ≥1 study vaccination and had follow-up data available

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Senior Vice President, Global Clinical Development

If the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%, then superiority of the V501 group is demonstrated.

Participants who were seronegative at Day 1 and PCR negative from Day 1 through Month 7 to the relevant HPV type, received all 3 vaccinations, did not deviate from the study protocol in ways that might interfere with vaccine efficacy, and had ≥1 follow-up visit after Month 7.

Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection

Participants who received ≥1 study vaccination and had follow-up data available.

Percentage of Participants With Maximum Temperature ≥37.5°C Reported on the Vaccination Report Card

Injection-site erythema

Injection-site pain

Injection-site swelling

Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card

Percentage of Participants With a Systemic Adverse Event

Percentage of Participants With a Vaccine-related Systemic Adverse Event

If the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%, superiority of the V501 group is demonstrated.

Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection or Disease

Overall Study

0.5 mL intramuscular injection on Day 1, Month 2, and Month 6

Quadrivalent HPV \[Type 6, 11, 16 and 18\] L1 VLP vaccine), 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6

This is a study of V501 \[quadrivalent Human Papillomavirus (HPV) (Type 6, 11, 16 and 18) L1 virus-like particle (VLP) vaccine\] in healthy Japanese boys. This study will consist of two periods. Period I of the study is to evaluate the immunogenicity and tolerability of V501 up to Month 7. Period II of the study is to evaluate the long-term immunogenicity and safety from Month 7 to Month 30. Two analyses are planned. The first analysis will be conducted when all subjects have completed their Month 7 visit or have been discontinued before that time. The second analysis will be conducted at the end of study. The primary hypothesis tested in this study is that seroconversion rates for the vaccine HPV types will be \>90% at 4 weeks postdose 3.

Safety and Tolerability Study of V501 in Japanese Boys (V501-200)

A Phase III, Open-Label, Clinical Trial to Study the Safety and Immunogenicity of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP Particle (VLP) Vaccine in 9- to 15-Year-Old Japanese Boys

Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay 4 weeks after 3rd vaccination (Month 7). Antibody titers were expressed as milli Merck units/mL (mMU/mL). Seroconversion was defined as an anti-HPV 6 titer ≥20 mMU/mL, an anti-HPV 11 titer ≥16 mMU/mL, an anti-HPV 16 titer of ≥20 mMU/mL and an anti-HPV 18 titer of ≥24 mMU/mL.

The parent/guardian of the participant was to record the participant's oral temperature in the evening after each study vaccination and daily for 4 days after each study vaccination. Elevated temperature was defined as ≥99.5°F (≥37.5ºC). The percentage of participants that had an elevated temperature was summarized.

An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The parent/guardian of the participant was to record the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 5 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, and swelling) was summarized.

An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The parent/guardian of the participant was to record the presence of any VRC-prompted systemic AEs that occurred in the 5 days after any vaccination. The percentage of participants with a systemic AE was summarized.

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event. The percentage of participants that experienced 1 or more SAEs was summarized.

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event. The percentage of participants that experienced 1 or more SAEs that were considered at least possibly related to the study vaccine was summarized.

Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay. Antibody titers were expressed mMU/mL. GMTs obtained for each anti-HPV from this study were compared to each of the ant-HPV GMTs obtained in study V501-122 (NCT NCT01862874) in which Japanese males 16 to 26 years received V501 in the same 3 dose regimen, to test a hypothesis that would demonstrate non-inferiority.

Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay. Antibody titers were expressed as mMU/mL.

Serum antibodies to HPV types were measured with a competitive luminex immunoassay. The serostatus cutoffs (mMU/mL) for HPV types were as follows: HPV Type 6: ≥20; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24

Serum antibodies to HPV types were measured with a competitive luminex immunoassay. The serostatus cutoffs (mMU/mL) for HPV types were as follows: HPV Type 6: ≥20; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24.

Population included all participants that received at least 1 vaccination

Ethnicity (NIH/OMB)

Anti HPV 6

Anti HPV 11

Anti HPV 16

Anti HPV 18

All participants that received all 3 vaccinations within acceptable day ranges, were seronegative to the relevant HPV type at Day 1, did not have protocol violations that could interfere with evaluation of the immune response, and provided Month 7 serology result within 21 to 49 days post dose 3.

Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18

≥ 37.5 °C (99.5 °F) and < 38.0 °C (100.4 °F)

≥ 38.0 °C (100.4 °F) and < 38.5 °C (101.3 °F)

≥ 38.5 °C (101.3 °F)

All participants who received at least 1 study vaccination and had follow-up safety data.

Percentage of Participants With Elevated Oral Temperature (>=37.5° C)

Percentage of Participants With an Injection-site Adverse Event

Percentage of Participants With a Serious Adverse Event

Percentage of Participants With a Vaccine-related Serious Adverse Event

Anti-HPV 6

Anti-HPV 11

Anti-HPV 16

Anti-HPV 18

Participants Aged 9 to 15 Years (PN200)

Participants Aged 16 to 26 Years (PN122)

Participants 9 to 15 years old (PN200) or 16 to 26 years old (PN122) that received all 3 vaccinations within acceptable day ranges, were seronegative to the relevant HPV type at Day 1, did not have protocol violations that could interfere with evaluation of the immune response, and provided Month 7 serology result within 21 to 49 days post dose 3.

Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18 Participants Aged 9 to 15 Years Versus Participants Aged 16 to 26 Years

All participants that received all 3 vaccinations within acceptable day ranges, were seronegative to the relevant HPV type at Day 1, did not have protocol violations that could interfere with evaluation of the immune response, and provided Month 18 data within an acceptable date range of 12 months postdose 3.

Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 18 Months

All participants that received all 3 vaccinations within acceptable day ranges, were seronegative to the relevant HPV type at Day 1, did not have protocol violations that could interfere with evaluation of the immune response, and provided Month 30 data within an acceptable date range of 24 months postdose 3.

Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 30 Months

Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 18 Months

Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 30 Months

Warts

Skin Diseases

Skin Diseases, Viral

Skin Diseases, Infectious

Pharmaceutical Solutions

Anti-Infective Agents

Formaldehyde

Biopsied from genital warts will be taken through an excisional procedure. Homeostasis will be obtained by using apply of Monsel solution. Biopsied sample will be splinted in order to obtain two pieces, one of them will be frozen (liquid Nitrogen) and designated to the HPV DNA PCR test (GP5, GP6) to be performed at the immunology lab at the National Cancer Institute in Bogotá. The other one will be kept in Formalin solution (10%) and sent to the pathology laboratory for haematoxiline - eosine paint and lecture.

Biopsy Excisional

Gustavo J. Hernandez-Suarez, MD

HPV infection has been recognized as the most prevalent sexual transmitted infection worldwide. Burden of many HPV related diseases is well known particularly regarding the different associated cancers (cervical, anal, vaginal, vulvar, oro-pharyngeal) (3) ; however, there is much less available information on the general burden of genital warts, the associated HPV types, the costs of related medical treatments and the knowledge and perceptions towards the disease and its prevention.

Objectives:

1. To determine the HPV genotypes distribution in genital warts in the study population.
2. To assess the knowledge about transmission \& prevention of HPV infection related diseases
3. To determine the direct medical costs of genital warts attention.

Study population

Female and male between 18 - 45 years of age living in Bogota, Colombia

Sample frame

Patients attending to gynecologic or STD consult in a mayor out patient clinic in Bogotá (PROFAMILIA)

Analysis

Analysis of the information will be exhaustive. We will calculate prevalence of HPV genotypes in the GW in both sexes separately. Analyses of the survey will include simple frequencies, percentages, and comparison of results related to HPV knowledge with sociodemographic and clinical information. Explorative analysis using parametric or non parametric statistics of the items included in the questionnaire and clinical forms will be done as appropriate. We will calculate the medical cost of patients enrolled in the study. The treatment protocols used for this protocol will reflect the current clinical practice accepted for the treatment of genital warts. We will use national reference cost list (SOAT) to determine the cost of procedures included.

Biopsies from genital warts will be taken through an excisional procedure. Homeostasis will be obtained by using topications of Monssell solution. Biopsy sample will be splinted in order to obtain two pieces, one of them will be frozen (liquid Nitrogen) and designated to the HPV DNA PCR test (GP5, GP6) to be performed at the immunology lab at the National Cancer Institute in Bogotá. The other one will be kept in Formalin solution (10%) and sent to the pathology laboratory for haematoxiline - eosine paint and lecture.

Human Papillomavirus (HPV) Genotypes in Genital Warts in Colombian Population

Prevalence of HPV Genotypes in Genital Warts in Colombian Male and Female Population Attending Medical Services.

La Fundacion para la Investigacion y el Desarrollo

MD MSc

Antineoplastic Agents

Ammonium trichloro(dioxoethylene-O,O'-)tellurate

Adjuvants, Immunologic

Protective Agents

Radiation-Protective Agents

Reverse Transcriptase Inhibitors

Enzyme Inhibitors

Antiviral Agents

15% AS101 ointment applied twice a day for treatment of external genital warts.

AS101 15% ointment will be applied topically twice daily on external genital warts for up to 16 weeks.

Topical AS101

Shabtai Romano, MD

The purpose of this study is to determine whether the improved topical ointment formulation, AS101, is safe and effective in the treatment of external genital warts in females.

Human papillomavirus (HPV)-induced condyloma acuminata (CA), commonly known as anogenital or genital warts, is among the most common sexually transmitted diseases. There are a wide variety of available treatments of genital warts, but none are considered completely effective. It has been suggested that AS101 works by stimulating the innate and acquired arms of the immune system.

In previous proof-of-concept clinical study AS101 topical cream was tested on HPV warts and shown cure in high percentages. However the cream formulation was unstable therefore a new formulation was developed mainly for the carrier. In this study the improved AS101 ointment will be tested in female patients with external genital warts in an open study to assess its safety and efficacy.

Safety and Efficacy Study to Test Topical AS101 for External Genital Warts

A Phase I/II, Open Labeled, Uncontrolled, Single Center Study of Topical AS101 for External Genital Warts

BioMAS Ltd

vehicle gel is used as a control group. The maximum daily dosage is 3 times of 400+/-100 mg of gel, meaning no more than 1,500 mg of gel. Patients should wash thoroughly their hands, then squeeze until 4 cm of gel is out from the aluminum tube. Apply gel on the lesion warts and on the clinical normal skin on the treated area.

SR-T100 contains 1.0% SM. The maximum daily dosage is 3 times of 400+/-100 mg of gel, meaning no more than 1,500 mg of gel. Patients should wash thoroughly their hands, then squeeze until 4 cm of gel is out from the aluminum tube. Apply gel on the lesion warts and on the clinical normal skin on the treated area.

SR-T100 contains 2.3% SM. The maximum daily dosage is 3 times of 400+/-100 mg of gel, meaning no more than 1,500 mg of gel. Patients should wash thoroughly their hands, then squeeze until 4 cm of gel is out from the aluminum tube. Apply gel on the lesion warts and on the clinical normal skin on the treated area.

Clinical diagnosed lesion site(s): Topical application once daily with occlusive dressing.

Clinical normal skin on treated area: Topical application thrice daily without occlusive dressing.

Total application \<1,500 mg gel per day.

Vehicle gel

SR-T100 gel with 1.0 % SM

SR-T100 gel with 2.3% SM

Kou-Wha Kuo, PhD

Cheng-Yang Chou, M.D.

To evaluate the efficacy of SR-T100 gel by observing total clearance rate of treated baseline EGW(s) on the treated area.

A double-blind, randomized,vehicle-controlled, parallel-group, and dose-ranging study to evaluate the efficacy and safety of SR-T100 gel in patients with EGW(s). The primary efficacy endpoint will be defined as the proportion of patients whose baseline EGW(s) on the treated area achieve total clearance. The efficacy of SR-T100 gel in prevention of new EGW(s) occurrence will be evaluated. Distinct to existing medications for EGWs, SR-T100 gel possesses characteristics of high safety and low LSR causality. SR-T100 gel will be administered on EGW lesion(s) for clearance and on the surrounding clinical normal skin for prevention of new EGW(s) occurrence.

Efficacy and Safety Profiles of SR-T100 Gel on External Genital Warts/Condyloma Acuminate(EGWs)

A Double-Blind, Vehicle Controlled, Randomized, Phase II Study of SR-T100 Gel on External Genital Warts/Condyloma Acuminate (EGWs)

including PE, vital sign, lab. test, local skin reaction, and adverse event, etc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Tolerability Study of V501 in Japanese Males (V501-122)	NCT01862874	Anogenital Huma... Condyloma Acumi...	V501 Placebo	16 Years - 26 Years	Merck Sharp & Dohme LLC
Safety and Tolerability Study of V501 in Japanese Boys (V501-200)	NCT02576054	Anogenital Huma... Condyloma Acumi...	V501	9 Years - 15 Years	Merck Sharp & Dohme LLC
Human Papillomavirus (HPV) Genotypes in Genital Warts in Colombian Population	NCT00847340	Genital Warts HPV Infections	Biopsy Excision...	18 Years - 45 Years	La Fundacion para la Investigacion y el Desarrollo
Human Papillomavirus (HPV) Genotypes in Genital Warts in Colombian Population	NCT00847340	Genital Warts HPV Infections	Biopsy Excision...	18 Years - 45 Years	La Fundacion para la Investigacion y el Desarrollo
Safety and Efficacy Study to Test Topical AS101 for External Genital Warts	NCT01555112	Wart; External ... Condyloma Acumi...	Topical AS101	18 Years -	BioMAS Ltd
Efficacy and Safety Profiles of SR-T100 Gel on External Genital Warts/Condyloma Acuminate(EGWs)	NCT01796821	Condyloma Acumi... Genital Warts Condylomata Acu... Venereal Warts	Vehicle gel SR-T100 gel wit... SR-T100 gel wit...	20 Years -	G&E Herbal Biotechnology Co., LTD

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