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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00798265 |
RATIONALE: Vaccine therapy may be effective in preventing human papillomavirus infection in young participants.
PURPOSE: This phase I trial is studying the side effects of vaccine therapy in preventing human papillomavirus infection in young participants who are either HIV-positive or HIV-negative.
Condition | Intervention | Phase |
---|---|---|
Anal Cancer Cervical Cancer Penile Cancer Precancerous/Nonmalignant Condition Vulvar Cancer |
Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine Genetic: DNA analysis Genetic: RNA analysis Genetic: protein analysis Other: immunologic technique Other: laboratory biomarker analysis Other: survey administration |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized |
Official Title: | A Phase I Study of Quadrivalent Human Papilloma Virus (HPV) (Types 6,11, 16, 18) Recombinant Vaccine in HIV-Infected and HIV-Negative Pre-Adolescents, Adolescents and Young Adults |
Estimated Enrollment: | 105 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Participants receive intramuscular quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine at 0, 2, and 6 months.
All participants complete human papillomavirus (HPV)/HIV knowledge and risk and sexual behavior surveys and undergo oral rinse/buccal swab and external anogenital sampling for HPV DNA testing at baseline. Blood samples are collected periodically for CD4 cell count, functional HPV antibody assay, HPV-specific lymphocyte proliferation assays (LPA), and cytokine profiling. HIV-positive patients (cohorts 1 and 2) also have blood samples collected for analysis of immunologic responses, HIV-1 RNA levels, and HIV-specific LPA.
After completion of study therapy, patients are followed periodically for 1 year and then every 6 months for 3 years.
NOTE: Preventing human papillomavirus (HPV) infection may prevent some HPV-associated cancers, such as cervical cancer and anogenital (vulvar, vagina, penis and anus) cancer.
Ages Eligible for Study: | 12 Years to 26 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
DISEASE CHARACTERISTICS:
Participants meeting one of the following criteria:
HIV-positive (cohorts 1 and 2)
Patients on stable highly active antiretroviral therapy for ≥ 6 months (cohort 1 only)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
At least 8 weeks since prior immunosuppressors or immunomodulators
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Principal Investigator: | Lauren V. Wood, MD | NCI - Vaccine Branch |
Study ID Numbers: | CDR0000625982, NCI-09-C-0024, NCI-P07277 |
Study First Received: | November 25, 2008 |
Last Updated: | July 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00798265 History of Changes |
Health Authority: | Unspecified |
human papilloma virus infection cervical cancer vulvar cancer |
anal cancer penile cancer HIV infection |
Precancerous Conditions Genital Neoplasms, Male Rectal Neoplasms Gastrointestinal Diseases Vulvar Cancer Urogenital Neoplasms Anal Cancer Rectal Diseases Genital Diseases, Female Vulvar Neoplasms Penile Neoplasms Papilloma Digestive System Neoplasms Skin Diseases Acquired Immunodeficiency Syndrome |
Rectal Neoplasm Genital Neoplasms, Female Genital Diseases, Male Intestinal Diseases Intestinal Neoplasms Virus Diseases Skin Diseases, Infectious Rectal Cancer Warts Digestive System Diseases HIV Seropositivity HIV Infections Gastrointestinal Neoplasms DNA Virus Infections Papillomavirus Infections |
Precancerous Conditions Genital Neoplasms, Male Rectal Neoplasms Gastrointestinal Diseases Tumor Virus Infections Urogenital Neoplasms Rectal Diseases Genital Diseases, Female Neoplasms by Site Vulvar Neoplasms Penile Neoplasms Digestive System Neoplasms Skin Diseases Genital Neoplasms, Female Intestinal Diseases |
Genital Diseases, Male Penile Diseases Intestinal Neoplasms Skin Diseases, Viral Virus Diseases Skin Diseases, Infectious Neoplasms Warts Digestive System Diseases Gastrointestinal Neoplasms DNA Virus Infections Papillomavirus Infections Anus Neoplasms Anus Diseases Vulvar Diseases |