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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) National Institute of Dental and Craniofacial Research (NIDCR) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00604175 |
Human papillomavirus (HPV) is the most common sexually transmitted disease in the world. HPV infection can cause genital warts and certain cervical problems, including cervical cancer. HPV infection may be more severe and harder to treat in HIV-infected people. The purpose of this study is to determine whether the quadrivalent HPV vaccine is safe, tolerable, and effective in producing antibodies to HPV in HIV-infected women.
Condition | Intervention | Phase |
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HIV Infections Sexually Transmitted Diseases |
Biological: Quadrivalent human papillomavirus vaccine |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Females |
Estimated Enrollment: | 402 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Stratum A: Active Comparator
Participants with a CD4 count greater than 350 cells/mm3 will receive the quadrivalent HPV vaccine at study entry and Weeks 8 and 24.
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Biological: Quadrivalent human papillomavirus vaccine
All groups will receive the vaccine via intramuscular injection
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Stratum B: Active Comparator
Participants with a CD4 count between 200 and 350 cells/mm3 will receive the quadrivalent HPV vaccine at study entry and Weeks 8 and 24.
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Biological: Quadrivalent human papillomavirus vaccine
All groups will receive the vaccine via intramuscular injection
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Stratum C: Active Comparator
Participants with a CD4 count 200 cells/mm3 or less will receive the quadrivalent HPV vaccine at study entry and Weeks 8 and 24.
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Biological: Quadrivalent human papillomavirus vaccine
All groups will receive the vaccine via intramuscular injection
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HPV is a DNA virus that affects both men and women. Approximately 90 types of HPV have been identified, 30 of which are sexually transmitted. The most common forms of HPV are types 6, 11, 16, and 18. The quadrivalent HPV vaccine that will be tested in this study has been shown in previous studies to be effective in preventing infection with HPV 6, 11, 16, and 18 in healthy young women. According to a report by the Centers for Disease Control and Prevention (CDC), 80% of women will have acquired HPV by the age of 50. HIV infected women have been reported to have a higher prevalence and persistence of HPV infection, as well as an increased risk for abnormal Pap smears and cervical cancer. HPV types 16 and 18 cause the majority of cervical cancers worldwide, and types 6 and 11 are responsible for the majority of cases of genital warts. Vaccinations for preventable infections are particularly important among HIV infected people because people with HIV have compromised immune systems; therefore, any infection is very serious and can potentially be fatal. However, standard vaccination series have not been very successful because a compromised immune system may not produce the desired immune response to a vaccine. The HPV vaccine is designed to protect against infection with HPV types 6, 11, 16, and 18 and has been approved by the FDA for use in women between the ages of 9 and 26. The purpose of this study is to determine whether the quadrivalent HPV vaccine is safe, tolerable, and effective in producing antibodies to HPV in HIV infected females.
This study will last 72 weeks. Participants will receive their first dose of the HPV vaccine by intramuscular injection. The HPV vaccine will be administered again at Weeks 8 and 24. Following each injection, participants will remain at the clinic for 30 minutes of observation for adverse events. A phone call from or a home visit by study staff will occur within 2 days following each injection.
Participants will return to the clinic for visits at Weeks 4, 8, 12, 24, 28, 52, and 72. Most study visits will include a physical exam, medication review, blood and urine collection, and answering questions about signs and symptoms since study screening. Some visits will include measurement of HIV viral load in the cervix, a cervical brush, an anal swab, and an oral exam. Some participants will be asked to provide additional blood samples.
Ages Eligible for Study: | 13 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Erna Milunka Kojic, MD | Department of Immunology/Infectious Disease, The Miriam Hospital, Brown University |
Study Chair: | Susan Cu-Uvin, MD | Obstetrics-Gynecology and Medicine, The Miriam Hospital, Brown University |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | ACTG A5240 |
Study First Received: | January 17, 2008 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00604175 |
Health Authority: | United States: Food and Drug Administration |
HIV-1 HPV 6 HPV 11 |
HPV 16 HPV 18 Vaccine |
Genital Diseases, Female Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Acquired Immunodeficiency Syndrome |
Sexually Transmitted Diseases Genital Diseases, Male Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |