Myron J Levin1, Sharon Huang2, Anna-Barbara Moscicki3, Lin-Ye Song4, Jennifer S Read5, William A Meyer6, Alfred J Saah7, Kelly Richardson8, Adriana Weinberg9. 1. Section of Pediatric Infectious Diseases, Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, United States. Electronic address: myron.levin@ucdenver.edu. 2. Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, MA 02115, United States. 3. Department of Pediatrics, University of California Los Angeles, Los Angeles, CA 19954, United States. 4. Formerly Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, MA 02115, United States; Office of Science, Food & Drug Administration; Silver Spring, MD 20993, United States. 5. Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, Bethesda, MD, United States. 6. Quest Diagnostics, Baltimore, MD, United States. 7. Merck & Co., Inc., Kenilworth, NJ, United States. 8. Section of Pediatric Infectious Diseases, Department of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, United States. 9. Section of Pediatric Infectious Diseases, Departments of Pediatrics, Medicine, and Pathology, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, United States.
Abstract
OBJECTIVE: Although HIV-infected children are recommended to receive quadrivalent human papillomavirus vaccine (QHPV) there is limited information on their response to QHPV. This study in HIV-infected children, evaluated the magnitude and duration of immune responses to QHPV. This report describes type-specific serum antibody responses over a 4-to-5year period after either 3 or 4 doses of QHPV. DESIGN/ METHODS: HIV-infected children, ages 7-to-11years, received 3 doses ofQHPV (n=96) or placebo (n=30). At 72weeks QHPV recipients received a fourth dose (n=84), while placebo recipients began the 3-dose QHPV schedule (n=27). HPV serotype-specific antibody was determined, by competitive Luminex immunoassay (cLIA) and IgG Luminex immunoassay, at 2, 3.5, and 4-to-5years after the last dose of QHPV in each treatment arm. RESULTS: At 4-to-5years after the last dose of QHPV, antibody titers were significantly higher in 4-dose than in 3-dose group. However, the proportion of vaccinees with a seroresponse in the cLIA assay was not different between the two groups (86-93% for HPV types 6, 11, and 16, and 64% for HPV type 18). These results were very similar to the seroresponse rate in these HIV-infected children at 1month after completing vaccination. CONCLUSIONS:Children with well-controlled HIV infection who receive 3 doses of the QHPV vaccine maintain seropositivity and antibody levels that are generally similar to children of the same age who are not HIV-infected. Antibody titer correlated strongly with low log HIV RNA, low CD8%, and high CD4%. Additionally, a fourth dose of vaccine in HIV-infected children produces a marked rise in antibody characteristic of an anamnestic response and persistence of high antibody levels. Study identification: IMPAACT P1085 (V501-021). CLINICALTRIALS.GOV identifier: NCT01206556.
RCT Entities:
OBJECTIVE: Although HIV-infectedchildren are recommended to receive quadrivalent human papillomavirus vaccine (QHPV) there is limited information on their response to QHPV. This study in HIV-infectedchildren, evaluated the magnitude and duration of immune responses to QHPV. This report describes type-specific serum antibody responses over a 4-to-5year period after either 3 or 4 doses of QHPV. DESIGN/ METHODS:HIV-infectedchildren, ages 7-to-11years, received 3 doses of QHPV (n=96) or placebo (n=30). At 72weeks QHPV recipients received a fourth dose (n=84), while placebo recipients began the 3-dose QHPV schedule (n=27). HPV serotype-specific antibody was determined, by competitive Luminex immunoassay (cLIA) and IgG Luminex immunoassay, at 2, 3.5, and 4-to-5years after the last dose of QHPV in each treatment arm. RESULTS: At 4-to-5years after the last dose of QHPV, antibody titers were significantly higher in 4-dose than in 3-dose group. However, the proportion of vaccinees with a seroresponse in the cLIA assay was not different between the two groups (86-93% for HPV types 6, 11, and 16, and 64% for HPV type 18). These results were very similar to the seroresponse rate in these HIV-infectedchildren at 1month after completing vaccination. CONCLUSIONS:Children with well-controlled HIV infection who receive 3 doses of the QHPV vaccine maintain seropositivity and antibody levels that are generally similar to children of the same age who are not HIV-infected. Antibody titer correlated strongly with low log HIV RNA, low CD8%, and high CD4%. Additionally, a fourth dose of vaccine in HIV-infectedchildren produces a marked rise in antibody characteristic of an anamnestic response and persistence of high antibody levels. Study identification: IMPAACT P1085 (V501-021). CLINICALTRIALS.GOV identifier: NCT01206556.
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