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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00339040 |
The purpose of this study is to determine the safety of and immune response to a new human papillomavirus (HPV) vaccine in HIV infected children between the ages of 7 and 12 years.
Condition | Intervention | Phase |
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HIV Infections Sexually Transmitted Diseases |
Biological: Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) Other: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II Safety and Immunogenicity Study of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in HIV Infected Children 7 to 12 Years of Age |
Estimated Enrollment: | 120 |
Study Start Date: | October 2006 |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive three doses of the HPV vaccine and an additional doses at Week 96.
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Biological: Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP)
HPV vaccine given at study entry, Weeks 8, 24 and 96.
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2: Placebo Comparator
Participants will receive three doses of the placebo vaccine and additional doses of the vaccine at Weeks 96, 104 and 120.
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Other: Placebo
Placebo vaccine
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Genital HPV infection is the most common sexually transmitted infection in the world and may lead to genital warts, anogenital dysplasias, and invasive cancers. HIV infected people and others with compromised immunity are at greater risk for HPV-related complications. In particular, researchers are concerned about the risk of HPV infection to women, who may be infected by their male partners, especially if these partners engage in anal intercourse. HIV infected women tend to have multiple types of HPV (associated with a greater risk of HPV-related disease), are less likely to clear HPV-related conditions, and are more likely to progress to HPV-related disease. The quadrivalent HPV (types 6, 11, 16, 18) L1 virus-like particle (VLP) vaccine to be tested in this study was safe and generally well tolerated in previous studies conducted in healthy and HPV-exposed adolescents, young adults, and older women. However, it is still unclear if the vaccine will be safe and will elicit a similar immune response in younger children. The purpose of this study is to evaluate the safety and immunogenicity of the novel quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP vaccine in HIV infected children 7 to 12 years of age.
This study has two stages and will last at least 108 weeks. In Stage I, participants will be randomly assigned to one of two groups; within their group, they will be stratified by CD4 count percentage (CD4%) nadir and CD4% at study screening. During Stage I, Group 1 participants will receive 3 doses of vaccine, while Group 2 participants will receive 3 doses of placebo. Participants will not know whether they are receiving vaccine or placebo.
Participants will receive their assigned intervention at study entry and Weeks 8 and 24. At Week 96, Stage II will begin, and all study participants will be told if they received vaccine or placebo in Stage I. Group 1 participants will receive an additional dose of vaccine at Week 96; Group 2 will receive doses of vaccine at Weeks 96, 104, and 120. Over the course of the study, there will be at least 12 study visits. A physical exam and blood collection will occur at most visits; medical history will occur at selected visits.
After each vaccination, participants will be observed for at least 30 minutes to monitor for any allergic reactions possibly resulting from the vaccination. For 15 days following vaccination, parents or guardians will be asked to complete a "report card" with details of each child's signs and symptoms. Three days after each vaccination, parents or guardians of study participants will be contacted by telephone and asked about any adverse events that a child may have experienced.
Ages Eligible for Study: | 7 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Myron J. Levin, MD | Pediatric Infectious Diseases Section, University of Colorado Health Sciences Center |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | PACTG P1047 |
Study First Received: | June 19, 2006 |
Last Updated: | July 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00339040 History of Changes |
Health Authority: | United States: Food and Drug Administration |
HPV |
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 Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Genital Diseases, Male |
Immunologic Deficiency Syndromes Genital Diseases, Female Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |