Infections

All Conditions

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Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Communicable Diseases

Papillomavirus Infections

Papilloma

Virus Diseases

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

9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6

Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6

9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection

V503

Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection

GARDASIL

Medical Director

Primary objective

To demonstrate that administration of V503 induces non-inferior Geometric Mean Titres (GMTs) for serum anti-HPV 6, 11, 16, and 18, compared to GARDASIL in 16- to 26-year-old men

Secondary objectives

* To evaluate the tolerability of V503 in 16- to 26-year-old men.
* To summarise humoral immune responses, including anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, 58 GMTs and seroconversion rates at 4 weeks post-dose 3, in 16- to 26-year-old men who received V503 or GARDASIL

A Study to Compare Immune Response of V503 to Gardasil in 16- to 26-year-old Men (V503-020)

A Randomized, Double-Blinded, Controlled With GARDASIL (Human Papillomavirus Vaccine [HPV] [Types 6, 11, 16, 18] (Recombinant, Adsorbed)), Phase 3 Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus L1 Virus-Like Particle [VLP] Vaccine) in 16- to 26-year-old Men

Serum antibodies to HPV types 6, 11, 16, and 18 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL.

Serum antibodies to HPV types 31, 33, 45, 52, and 58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL.

Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24; HPV Type 31: ≥10; HPV Type 33: ≥8; HPV Type 45: ≥8; HPV Type 52: ≥8; HPV Type 58: ≥8.

The percentage of participants with one or more adverse events was assessed.

The percentage of participants discontinued from the study due to an adverse event was assessed.

The percentage of participants with one or more injection-site adverse reactions (solicited or unsolicited) was assessed.

The percentage of participants with a maximum temperature ≥37.8 °C was assessed.

The percentage of participants with one or more systemic adverse events was assessed.

The percentage of participants with one or more serious adverse events was assessed.

Merck Sharp & Dohme LLC

Total

Age, Continuous

<18 years old

>=18 years old

Age, Customized

Sex: Female, Male

Senior Vice President, Global Clinical Development

HPV Type 6

HPV Type 11

HPV Type 16

HPV Type 18

All randomized participants. The number contributing to each data point is participants who received all 3 vaccinations within acceptable day ranges, had Month 7 serology for the HPV type within acceptable day ranges, were seronegative at Day 1, and had no protocol violations that interfered with evaluation of immune response.

Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18

HPV Type 31

HPV Type 33

HPV Type 45

HPV Type 52

HPV Type 58

All randomized participants. The number contributing to each data point is participants who received all 3 vaccinations within acceptable day ranges, had Month 7 serology for the HPV type within acceptable day ranges, were seronegative at Day 1, and had no protocol violations that interfered with evaluation of immune response

GMTs to HPV Types 31/33/45/52/58

Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58

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

Percentage of Participants With One or More Adverse Events

Percentage of Participants With Study Discontinuation Due to an Adverse Event

Percentage of Participants With One or More Injection-site Adverse Reactions

Percentage of Participants With Maximum Temperature ≥37.8 °C

Percentage of Participants With One or More Systemic Adverse Events

Percentage of Participants With One or More Serious Adverse Events

Overall Study

Skin and Connective Tissue Diseases

Carcinoma

Warts

Carcinoma, Verrucous

Antioxidants

The experimental arm will receive nutritional supplements Viusid + Glizigen

The control group will receive a placebo of both (Viusid and Glizigen).

The VIUSID nutritional supplement is presented in the form of envelopes and will be administered orally diluted in water, juice or milk, according to the patient's preference and will be administered 3 times a day, 15 minutes before breakfast, lunch and dinner.

Viusid®

The GLIZIGEN® product is presented in spray bottles and will be administered orally to swallow, away from meals 2 times a day.

Glizigen®

The placebo of VIUSID nutritional supplement is presented in the form of envelopes and will be administered orally diluted in water, juice or milk, according to the patient's preference and will be administered 3 times a day, 15 minutes before breakfast, lunch and dinner .

Viusid Placebo

The placebo of GLIZIGEN® product is presented in spray bottles and will be administered orally to swallow, away from meals 2 times a day.

Glizigen Placebo

A randomized, double-blind, phase II clinical trial was conducted versus placebo in 110 patients with esophageal human papillomavirus. The experimental group will receive the VIUSID® plus GLIZIGEN® nutritional supplements, administered on an outpatient basis for 3 months. The control group will receive placebo from Viusid plus Glizigen placebo. It is expected that patients in the experimental group have a 30% higher rate of elimination of the virus than patients in the placebo group after treatment. The study will be conducted in the Superior Digestive Tract consultation of the Institute of Gastroenterology of Havana, Cuba.

Initially the study was planned as an adaptive study without seams, phase II / III for 150 patients. 75 in each therapeutic arm. The sample size was calculated with parameters of phase III studies, but establishing an early stop rule, with an intermediate analysis. For the calculation it was taken into account that the expected percentage of elimination of the virus by spontaneous remission in immunocompetent patients, reported internationally is on average 35%. It is intended that in the group of patients to whom VIUSID® plus GLIZIGEN® will be administered, this figure is ≥ 65%. In other words, it is desired to reach a minimum difference of approximately 30% between both groups. Considering a type I error of 5% (adjusted to 2.5% by an intermediate evaluation), a power of 90%, plus 5% of dropouts or losses to follow-up, the minimum number of patients to recruit is 150 patients in total , 75 in each therapeutic arm.

However, by decision of the promoter the study was stopped with 55 patients in each arm, 110 patients in total. And established as a phase II trial.

Random assignment, through a list obtained by computer. Patients will be randomized in the consultation of the upper digestive tract, once the anatomopathological result with the presence of coilocytes is received, and they meet the established selection criteria.

A double blind. To achieve the masking of the research product, these have been labeled by a computerized randomized balanced list, which will be in the possession of the promoter and the study Biostatistician. The masking will be maintained until the analysis of the data. However, access to the code will be allowed if serious adverse events arise related to the research product.

Efficacy of VIUSID® Plus GLIZIGEN® in Patients With Papilloma Virus Esophageal

Efficacy and Safety of VIUSID® Plus GLIZIGEN® in Patients With Papilloma Virus Esophageal. Phase II Clinical Trial

Absence of coilocytes / papilloma in the paraffin sample

Negativization of the virus in fresh sample of the mucosa in the PCR study

Papillary hyperplasia lamina propria: Yes or no

Hyperplasia of the basal layer of the epithelium: Yes or No

Dysplasia: Yes (Low Degree or High Degree) or No

It will be determined through the reporting of adverse events that are presented to the research product

Catalysis SL

The main objective of this study is to find out whether young MSM (men who have sex with men) believe it is important for their GP to be informed of their sexual orientation, in order to improve their clinical, especially with HPV vaccination.

The secondary objective is to analyze the state of knowledge about the HPV vaccine and the value of HPV vaccine in this target population.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Compare Immune Response of V503 to Gardasil in 16- to 26-year-old Men (V503-020)	NCT02114385	Papilloma Viral...	V503 GARDASIL	16 Years - 26 Years	Merck Sharp & Dohme LLC
Efficacy of VIUSID® Plus GLIZIGEN® in Patients With Papilloma Virus Esophageal	NCT03584308	Papilloma Viral... Papillomavirus ... Esophageal Vira... Esophageal Verr...	Viusid® Glizigen® Viusid Placebo Glizigen Placeb...	18 Years - 65 Years	Catalysis SL
HPV and Male Homosexuality in General Practice?	NCT05078554	Papilloma Viral...		18 Years - 26 Years	University Hospital, Strasbourg, France

Spots Global Cancer Trial Database for papilloma viral infection