Immunogenicity and safety of 1 vs 2 doses of quadrivalent meningococcal conjugate vaccine in youth infected with human immunodeficiency virus
Jorge Lujan-Zilbermann, Meredith G Warshaw, Paige L Williams, Stephen A Spector, Michael D Decker, Mark J Abzug, Barb Heckman, Adam Manzella, Bill Kabat, Patrick Jean-Philippe, Sharon Nachman, George K Siberry, International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1065 Protocol Team, Kenneth D Braun Jr, Donna Picard, Paul Tran, Scott Watson, James Oleske, Arlene Bardeguez, Arry Dieudonne, Linda Bettica, Nicole Falgout, Joseph Geffen, Karin Nielsen, Jaime Deville, Chivon Jackson, Shelley Buscher, Faith Mingala, Mary E Paul, Alice Higgins, Andrea Jurgrau, Marc Foca, Seydi Vasquez, Gwendolyn B Scott, Charles D Mitchell, Patricia Bryan, Claudia Florez, Rolando M Viani, Jeanne Manning, Kim Norris, Margaret Donnelly, Joan Wilson, Mary Jo Hassett, Kathleen McGann, Aditya Kaul, Sulachni Chandwani, William Borkowsky, Nagamah Deygoo, Andrew Wiznia, Marlene Burey, Jorge Sansary, Francisco Reinoso, Ann J Melvin, Lisa M Frenkel, Joycelyn Thomas, Denise Casey, Carolyn Graisbery, Gail Lewis, Carina Rodriguez, Midnela Acevedo-Flores, Milagros González-Díaz, Lizbeth Fábregas, Denise Ferraro, Erin Infanzon, Michele Kelly, Ellen C Moore, Chokechai Rongkavilit, Elizabeth Secord, Ulyssa Hancock, Sohail Rana, Helga Finke-Castro, Meseret Deressa, Connie Nguyen, James Homans, Andrea Kovacs, LaShonda Spencer, Michael Neely, Mobeen H Rathore, Nizar Maraqa, Kathy Thoma, Chas Griggs, Myron J Levin, Emily Barr, Megan Canon, Jason Child, Ana M Puga, Kathleen Graham, Kevin Brown, Carol Owens, Geoffrey A Weinberg, Barbra Murante, Susan Laverty, Francis Gigliotti, Marvin Belzer, Johanna Olson, Diane Tucker, Nancy Flores, Jill Utech, Nehali Patel, Lennie Lott, Aditya H Gaur, Irma Febo, Licette Lugo, Ruth Santos, Maritza Cruz, Steven D Douglas, Richard M Rutstein, Carol A Vincent, Patricia C Coburn, Aida Matias, Mavis Dummitt, Stefan Hagmann, Murli Purswani, Richard Moriarty, Katherine Luzuriaga, Jessica Pagano-Therrien, Ram Yogev, Jorge Lujan-Zilbermann, Meredith G Warshaw, Paige L Williams, Stephen A Spector, Michael D Decker, Mark J Abzug, Barb Heckman, Adam Manzella, Bill Kabat, Patrick Jean-Philippe, Sharon Nachman, George K Siberry, International Maternal Pediatric Adolescent AIDS Clinical Trials Group P1065 Protocol Team, Kenneth D Braun Jr, Donna Picard, Paul Tran, Scott Watson, James Oleske, Arlene Bardeguez, Arry Dieudonne, Linda Bettica, Nicole Falgout, Joseph Geffen, Karin Nielsen, Jaime Deville, Chivon Jackson, Shelley Buscher, Faith Mingala, Mary E Paul, Alice Higgins, Andrea Jurgrau, Marc Foca, Seydi Vasquez, Gwendolyn B Scott, Charles D Mitchell, Patricia Bryan, Claudia Florez, Rolando M Viani, Jeanne Manning, Kim Norris, Margaret Donnelly, Joan Wilson, Mary Jo Hassett, Kathleen McGann, Aditya Kaul, Sulachni Chandwani, William Borkowsky, Nagamah Deygoo, Andrew Wiznia, Marlene Burey, Jorge Sansary, Francisco Reinoso, Ann J Melvin, Lisa M Frenkel, Joycelyn Thomas, Denise Casey, Carolyn Graisbery, Gail Lewis, Carina Rodriguez, Midnela Acevedo-Flores, Milagros González-Díaz, Lizbeth Fábregas, Denise Ferraro, Erin Infanzon, Michele Kelly, Ellen C Moore, Chokechai Rongkavilit, Elizabeth Secord, Ulyssa Hancock, Sohail Rana, Helga Finke-Castro, Meseret Deressa, Connie Nguyen, James Homans, Andrea Kovacs, LaShonda Spencer, Michael Neely, Mobeen H Rathore, Nizar Maraqa, Kathy Thoma, Chas Griggs, Myron J Levin, Emily Barr, Megan Canon, Jason Child, Ana M Puga, Kathleen Graham, Kevin Brown, Carol Owens, Geoffrey A Weinberg, Barbra Murante, Susan Laverty, Francis Gigliotti, Marvin Belzer, Johanna Olson, Diane Tucker, Nancy Flores, Jill Utech, Nehali Patel, Lennie Lott, Aditya H Gaur, Irma Febo, Licette Lugo, Ruth Santos, Maritza Cruz, Steven D Douglas, Richard M Rutstein, Carol A Vincent, Patricia C Coburn, Aida Matias, Mavis Dummitt, Stefan Hagmann, Murli Purswani, Richard Moriarty, Katherine Luzuriaga, Jessica Pagano-Therrien, Ram Yogev
Abstract
Objective: To compare the immunogenicity of 1 vs 2 doses of meningococcal polysaccharide conjugate vaccine (MCV4) in youth infected with human immunodeficiency virus (HIV).
Study design: P1065 was a phase I/II immunogenicity and safety trial of MCV4 in 324 youth infected with HIV performed at 27 sites of the International Maternal Pediatric Adolescent AIDS Clinical Trials Group network in the US. At entry subjects received 1 dose of MCV4. At 24 weeks, those with screening cluster of differentiation 4 (CD4)% ≥ 15 were randomized to receive a second dose or not, and all with screening CD4% <15 received a second dose. Immunogenicity was evaluated as the proportion of subjects with a ≥ 4-fold rise from entry in serum bactericidal antibody against each meningococcal serogroup (SG) at weeks 28 and 72. Logistic regression models adjusting for HIV disease severity were used to evaluate the effect of 1 vs 2 MCV4 doses among those with screening CD4% ≥ 15.
Results: Subjects randomized to receive 2 vs 1 MCV4 dose had significantly higher response rates to all SGs at week 28 and to all except Neisseria meningitidis SG Y at week 72, with adjusted ORs of 2.5-5.6. In 31 subjects with screening CD4% <15 who received 2 MCV4 doses, response rates ranged from 22%-55% at week 28 and 6%-28% at week 72.
Conclusion: In youth infected with HIV with a CD4% ≥ 15, a second dose of MCV4 given 6 months after the initial dose significantly improves response rates at 28 and 72 weeks. Subjects with CD4% <15 at entry had lower response rates despite 2 doses of MCV4.
Trial registration: ClinicalTrials.gov NCT00459316.
Conflict of interest statement
Financial support and conflict of interest information is available at www.jpeds.com (Appendix 2). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
Copyright © 2012 Mosby, Inc. All rights reserved.
Figures
Source: PubMed