Two-dose Schedule of Quadrivalent HPV Recombinant Vaccine in 11-year-old Boys in Mexico City

Study Overview
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Brief Summary
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In the genital tract human papilloma virus (HPV), especially types 6 and 11 cause genital warts, the commonest viral sexually transmitted disease. The HPV 16 and 18 are the most common oncogenic high-risk genotypes and cause approximately 70% of all cervical cancers despite the fact that are associated with other anogenital cancers, anus, vagina, vulva and penis, and cancers of the head and neck. Current estimates are that 5.2% of all cancers are HPV associated. A large number of studies, including both adult and young females, have demonstrated that HPV vaccines are highly immunogenic and induce a long lasting protection against infection. Immunogenic vaccination results in young men and boys are equally satisfactory with the quadrivalent HPV (types 6, 11, 16, 18) vaccine recommended for men. The recommended vaccination scheme includes three shots giving the second at two months and the third at six months after the initial shot. Recently, it has been shown that the use of a two shot scheme (0 and 6 months) is equally effective among girls. The purpose of this study is to determine that the immunogenicity is non-inferior in boys using a two shot scheme compared with young women and girls.

Official Title
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Evaluation of a Two-dose Schedule of Quadrivalent Human Papilloma Virus (Types 6, 11, 16, 18) Recombinant Vaccine in 11-year-old Boys in Mexico City (Gardasil® Merck and Co.).

Conditions
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Human Papilloma Virus

Intervention / Treatment
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* Biological: quadrivalent human papillomavirus (types 6, 11, 16,18) recombinant vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All those children whose parents accept their participation in the study. Exclusion Criteria: Fever, previous vaccination against HPV, allergy to vaccine components, thrombocytopenia, immunosuppression, diarrhea, vomiting, dyscrasia, administration of another anti-viral vaccine in the previous 15 days.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>11 year old boys enrolled in fifth grade of 40 public elementary schools of Mexico City, from the political demarcations of Azcapotzalco, Gustavo A. Madero, Iztacalco, Miguel Hidalgo, Venustiano Carranza, Iztacalco and Tlalpan, reciving a two-dose vaccination scheme (0-6). 250 subjects will be recruited. | Biological: quadrivalent human papillomavirus (types 6, 11, 16,18) recombinant vaccine<br>* dose scheme (0 and 6 month)<br>* Other names: Gardasil;|
| Active Comparator: Cohort 2<br>Historical cohort of young women 18-24 years old recruited by Lazcano et. al. receiving a standard vaccination schedule (0-1-6 months). 500 subjects were recruited. | Biological: quadrivalent human papillomavirus (types 6, 11, 16,18) recombinant vaccine<br>* dose scheme (0 and 6 month)<br>* Other names: Gardasil;|
| Active Comparator: Cohort 3<br>11 year old girls enrolled in fifth grade of 40 public elementary schools of Mexico City, from the political demarcations of Azcapotzalco, Venustiano Carranza, Iztacalco and Tlalpan, reciving a two-dose vaccination scheme (0-6). 250 subjects will be recruited. | Biological: quadrivalent human papillomavirus (types 6, 11, 16,18) recombinant vaccine<br>* dose scheme (0 and 6 month)<br>* Other names: Gardasil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity (Geometric mean antibody concentration will be compared between the two groups) | Geometric means will be compared between the two groups of interest (boys and young women) | 7 months (1 month after the last dose) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quadrivalent, vaccine