Human papillomavirus (HPV) infection is the central etiologic factor in the development of cervical and anal cancers. Recent data suggest that it is causally involved in 30 percent of oral cancers. Studies by our group and others have shown that 30-60 percent of sexually active college age women have cervical HPV infection. Our inner-city adolescence population, with its many high risk (HR) characteristics, has a prevalence of 63 percent cervical, 58 percent anal and 13 percent oral in our pilot study. The new Gardasil vaccine contains HPV 6, 11, 16 & 18 virus-like particles and has been shown to have a very high efficacy in HPV-DNA negative and HPV seronegative subjects. Little is know about its efficacy and effectiveness in a HR adolescent population, or in anal and oral mucosa. Despite these uncertainties physicians would find it unacceptable to not vaccinate high-risk adolescents, such as our population. The results of our research may demonstrate the need for a formal clinical trial of high risk adolescents. We therefore propose to study incidence of HPV infection following Gardasil vaccination in a prospective cohort of 1000 sexually active adolescent girls, ages 12-19 enrolled at the Mount Sinai AHC. We will collect baseline cervical, anal, oral specimens for HPV DNA testing and serum for HPV antibodies, the vaccine naive subjects will complete the 3 necessary vaccinations. They will be followed every 6 months for two years. Serum will be collected at baseline and 12 months.
Our aims are to: 1) study the type-specific prevalence of HPV DNA in the cervix, anus, and oral cavity in high risk adolescents prior to vaccination including risk factors and co infection across sites; 2)determine the incidence of persistent HPV infection of the cervix following vaccination and contrast these rates with those expected based on the published vaccine trial results, by assessing incidence of persistent cervical infection in those adolescent women; 3)identify risk factors for an incidently developed persistent cervical infection with HPV, despite vaccination in those who were serologically and DNA negative for those types at baseline including infection in the anus or oral cavity and other risk factors; 4)study the incidence of persistent anal and oral infection with HPV following vaccination in this high risk cohort and the risk factors for infection with these HPV types in the anus, and to determine the incidence and risk factors for infection with phylogenetically- related and -unrelated HPV types in the anal and oral mucosa. ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project (R01)
Project #
5R01AI072204-02
Application #
7420925
Study Section
Infectious Diseases, Reproductive Health, Asthma and Pulmonary Conditions Study Section (IRAP)
Program Officer
David, Hagit S
Project Start
2007-05-15
Project End
2012-04-30
Budget Start
2008-05-01
Budget End
2009-04-30
Support Year
2
Fiscal Year
2008
Total Cost
$818,235
Indirect Cost
Name
Icahn School of Medicine at Mount Sinai
Department
Pediatrics
Type
Schools of Medicine
DUNS #
078861598
City
New York
State
NY
Country
United States
Zip Code
10029
Usyk, Mykhaylo; Zolnik, Christine P; Patel, Hitesh et al. (2017) Novel ITS1 Fungal Primers for Characterization of the Mycobiome. mSphere 2:
Gradíssimo, Ana; Burk, Robert D (2017) Molecular tests potentially improving HPV screening and genotyping for cervical cancer prevention. Expert Rev Mol Diagn 17:379-391
Nagpal, Julie; Linares, Lourdes Oriana; Weiss, Jocelyn et al. (2016) Knowledge about Human Papillomavirus and Time to Complete Vaccination among Vulnerable Female Youth. J Pediatr 171:122-7
Smith, Benjamin C; Zolnik, Christine P; Usyk, Mykhaylo et al. (2016) Distinct Ecological Niche of Anal, Oral, and Cervical Mucosal Microbiomes in Adolescent Women. Yale J Biol Med 89:277-284
Gordon, Lonna P; Diaz, Angela; Soghomonian, Christine et al. (2016) Increased Body Mass Index Associated with Increased Risky Sexual Behaviors. J Pediatr Adolesc Gynecol 29:42-7
Schlecht, Nicolas F; Diaz, Angela; Shankar, Viswanathan et al. (2016) Risk of Delayed Human Papillomavirus Vaccination in Inner-City Adolescent Women. J Infect Dis 214:1952-1960
Linares, Lourdes Oriana; Shankar, Viswanathan; Diaz, Angela et al. (2015) Association Between Cumulative Psychosocial Risk and Cervical Human Papillomavirus Infection Among Female Adolescents in a Free Vaccination Program. J Dev Behav Pediatr 36:620-7
Braun-Courville, Debra K; Schlecht, Nicolas F; Burk, Robert D et al. (2014) Strategies for conducting adolescent health research in the clinical setting: the Mount Sinai Adolescent Health Center HPV experience. J Pediatr Adolesc Gynecol 27:e103-8
Yavorsky, Risa L; Hollman, Dominic; Steever, John et al. (2014) Prevalence of sexually transmitted infections in at-risk adolescent females at a comprehensive, stand-alone adolescent health center in New York City. Clin Pediatr (Phila) 53:890-5
Ghartey, Jeny P; Smith, Benjamin C; Chen, Zigui et al. (2014) Lactobacillus crispatus dominant vaginal microbiome is associated with inhibitory activity of female genital tract secretions against Escherichia coli. PLoS One 9:e96659

Showing the most recent 10 out of 13 publications