Safety and immunogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, and 18) vaccine in HIV-infected children 7 to 12 years old
Myron J Levin, Anna-Barbara Moscicki, Lin-Ye Song, Terrence Fenton, William A Meyer 3rd, Jennifer S Read, Edward L Handelsman, Barbara Nowak, Carlos A Sattler, Alfred Saah, David R Radley, Mark T Esser, Adriana Weinberg, IMPAACT P1047 Protocol Team, Deidre Thompson, Jennifer Sween, Steven Zeichner, Ellen C Moore, Chokechai Rongkavilit, Elizabeth Secord, Ulyssa Hancock, Denise Ferraro, Erin Infanzon, Michele Kelly, Jill Utech, Sandra Jones, Nehali Patel, Lennie Lott, Russell B Van Dyke, Margarita Silio, Cheryl Borne, Sheila Bradford, Sandra Deygoo, William Borkowsky, Siham Akleh, Sulachni Chandwani, Margaret Donnelly, Mary Jo Hasseett, Joan Wilson, Kareema Whitfield, James B McAuley, Nike Mourikes, Maureen Haak, Kenneth Boyer, LaShonda Spencer, James Homans, Michael Neely, Andrea Kovacs, Audra Deveikis, Jagmohan Batra, Susan Marks, Janielle Jackson-Alvarez, Jennifer Armstrong, Ruth Williams, Eric Cagwin, Stephanie Osborne, Antonio Arrieta, Mavis Dummit, Caroline Nubel, Stefan Hagmann, Murli Purswani, Faith Minglana, Chivon McMullen-Jackson, Mary E Paul, William T Shearer, Midnela Acevedo-Flores, Milagros Gonzáles-Diaz, Lizbeth Fabrega, Wanda Marrero, Mobeen Rathore, Ayesha Mirza, Kathy Thoma, Chas Griggs, Mark Abzug, Emily Barr, Megan Canon, Carol Salbenblatt, Lisa Frenkel, Ann Melvin, Joycelyn Thomas, Geoffrey A Weinberg, Barbra Murante, Susan Laverty, Francis Gigliotti, Helga Finke-Castro, Sohail Rana, Connie Nguyen, Patricia Houston, Stephen A Spector, Rolando Viani, Kimberly Norris, Jeanne Manning, Ellen R Cooper, Diana Clarke, Laureen Kay, H J Moallem, J M Kaye, D Swindel, Ana Puga, Kathleen Graham, Lisa Bridges, Richard Sellars, Marlene Burey, Raphaelle Auguste, Elaine Perez, Francisco Reinoso, Myron J Levin, Anna-Barbara Moscicki, Lin-Ye Song, Terrence Fenton, William A Meyer 3rd, Jennifer S Read, Edward L Handelsman, Barbara Nowak, Carlos A Sattler, Alfred Saah, David R Radley, Mark T Esser, Adriana Weinberg, IMPAACT P1047 Protocol Team, Deidre Thompson, Jennifer Sween, Steven Zeichner, Ellen C Moore, Chokechai Rongkavilit, Elizabeth Secord, Ulyssa Hancock, Denise Ferraro, Erin Infanzon, Michele Kelly, Jill Utech, Sandra Jones, Nehali Patel, Lennie Lott, Russell B Van Dyke, Margarita Silio, Cheryl Borne, Sheila Bradford, Sandra Deygoo, William Borkowsky, Siham Akleh, Sulachni Chandwani, Margaret Donnelly, Mary Jo Hasseett, Joan Wilson, Kareema Whitfield, James B McAuley, Nike Mourikes, Maureen Haak, Kenneth Boyer, LaShonda Spencer, James Homans, Michael Neely, Andrea Kovacs, Audra Deveikis, Jagmohan Batra, Susan Marks, Janielle Jackson-Alvarez, Jennifer Armstrong, Ruth Williams, Eric Cagwin, Stephanie Osborne, Antonio Arrieta, Mavis Dummit, Caroline Nubel, Stefan Hagmann, Murli Purswani, Faith Minglana, Chivon McMullen-Jackson, Mary E Paul, William T Shearer, Midnela Acevedo-Flores, Milagros Gonzáles-Diaz, Lizbeth Fabrega, Wanda Marrero, Mobeen Rathore, Ayesha Mirza, Kathy Thoma, Chas Griggs, Mark Abzug, Emily Barr, Megan Canon, Carol Salbenblatt, Lisa Frenkel, Ann Melvin, Joycelyn Thomas, Geoffrey A Weinberg, Barbra Murante, Susan Laverty, Francis Gigliotti, Helga Finke-Castro, Sohail Rana, Connie Nguyen, Patricia Houston, Stephen A Spector, Rolando Viani, Kimberly Norris, Jeanne Manning, Ellen R Cooper, Diana Clarke, Laureen Kay, H J Moallem, J M Kaye, D Swindel, Ana Puga, Kathleen Graham, Lisa Bridges, Richard Sellars, Marlene Burey, Raphaelle Auguste, Elaine Perez, Francisco Reinoso
Abstract
Background: Quadrivalent human papillomavirus vaccine (QHPV) is > 95% effective in preventing infection with vaccine-type human papillomavirus. The safety and immunogenicity of QHPV are unknown in HIV-infected children.
Methods: HIV-infected children (N = 126)-age > 7 to < 12 years, with a CD4% ≥ 15-and on stable antiretroviral therapy if CD4% was < 25-were blindly assigned to receive a dose of QHPV or placebo (3:1 ratio) at 0, 8, and 24 weeks. Adverse events were evaluated after each dose. Serum antibody against QHPV antigens was measured by a competitive Luminex immunoassay 1 month after the third QHPV dose.
Results: The safety profile of QHPV was similar in the 2 study arms and to that previously reported for QHPV recipients. QHPV did not alter the CD4% or plasma HIV RNA. Seroconversion to all 4 antigens occurred in > 96% of QHPV recipients and in no placebo recipients. Geometric mean titer was > 27 to 262 times greater than the seropositivity cutoff value, depending on the antigen, but was 30%-50% lower against types 6 and 18 than those of age-similar historical controls.
Conclusions: QHPV was safe and immunogenic in this cohort of HIV-infected children. Efficacy trials are warranted.
Trial registration: ClinicalTrials.gov NCT00339040.
Source: PubMed